Search Results
CATALINA-2: A Phase 2 Study Evaluating the Efficacy and Safety of TORL-1-23 in Women with Advanced Platinum-Resistant Epithelial Ovarian Cancer (Including Primary Peritoneal and Fallopian Tube Cancers) Expressing Claudin 6
This study is being conducted to determine the safest and most effective dose of TORL-1-23 in treating advanced platinum-resistant ovarian cancer.
• diagnosis of advanced (unresectable) or metastatic (has spread) high grade serous ovarian, primary peritoneal (i.e, of primary origin), or fallopian tube cancer
• positive for CLDN6 expression
• have platinum-resistant disease
• may not be able to do strenuous activity but able to walk and carry out work of a light or sedentary nature, e.g., light house work, office work
• must agree to use a highly effective birth control method from the time of the first study drug treatment through 7 months after the last study drug treatment
• must agree to not breastfeed from the first dose of study treatment through 90 days after the last dose of study treatment
• see link to clinicaltrials.gov for complete inclusion criteria
• have not recovered from serious side effects of previous treatment
• progressive or symptomatic brain metastases
• history of significant heart disease
• history of another cancer within 3 years (exception of basal or squamous cell carcinoma of the skin)
• see link to clinicaltrials.gov for complete exclusion criteria
HM2025-16: Phase Ib/II Trial of Epcoritamab plus Ibrutinib in Patients with Relapsed/Refractory Aggressive B-cell Non-Hodgkin Lymphoma.
This phase Ib/II trial evaluates the safety, optimal dose, and efficacy of the combination of epcoritamab and ibrutinib in treating patients with aggressive B-cell non-Hodgkin lymphoma that has come back (relapsed) or responded to previous treatment (refractory).
• diagnosis of B-cell non-Hodgkin lymphoma
• have relapsed or refractory aggressive B-cell lymphoma and received prior treatment with an anthracycline in combination with an anti-CD20 monoclonal antibody
• treatment with autologous stem cell transplant (ASCT) is allowed if ≥ 100 days
• capable of all selfcare and able to walk but unable to carry out any work activities; up and about more than 50% of waking hours
• women of child-bearing potential and men must agree to use adequate contraception 2 weeks before starting treatment, for the duration of study participation and for 12 months after completing treatment
• see link to clinicaltrials.gov for complete Inclusion criteria
• active central nervous system (CNS) involvement
• active uncontrolled infection
• current uncontrolled or symptomatic cardiovascular conditions
• liver cirrhosis with moderate to severe liver impairment
• significant lung disease
• treatment with coumadin/warfarin
• women who are pregnant or breastfeeding
• see link to clinicaltrials.gov for complete Exclusion criteria
ITCC-101/APAL2020D - A randomized phase 3 trial of fludarabine/cytarabine/gemtuzumab ozogamicin with or without venetoclax in children with relapsed AML (A subtrial of the PedAL/EuPAL relapsed acute leukemia master protocol)
A study to evaluate if the randomized addition of venetoclax to a chemotherapy backbone (fludarabine/cytarabine/gemtuzumab ozogamicin [GO]) improves survival of children/adolescents/young adults with acute myeloid leukemia (AML) in 1st relapse who are unable to receive additional anthracyclines, or in 2nd relapse.
• participants must be at least 29 days of age and less than 21 years of age at enrollment
• participants must have enrolled on APAL2020SC, NCT Number: NCT04726241
• children, adolescents, and young adults with acute myeloid leukemia without FLT3/internal tandem duplication (ITD) mutation
• second relapse who are sufficiently fit to undergo another round of intensive chemotherapy
• first relapse who per investigator discretion cannot tolerate additional anthracycline containing chemotherapy
• see link to clinicaltrials.gov for complete criteria
• participants with Down syndrome
• participants with Acute promyelocytic leukemia (APL) or Juvenile myelomonocytic leukemia (JMML)
• study staff will review additional exclusion criteria
A Phase 1b Open-label, Multicenter Study Evaluating the Safety, Tolerability, and Efficacy of Xaluritamig in Combination with Androgen Receptor Pathway Inhibitors in Participants with Metastatic Hormone-sensitive Prostate Cancer
The main goal of this study is to see if it's safe for people to take xaluritamig together with either darolutamide or abiraterone.
• diagnosis of metastatic adenocarcinoma of the prostate
• started androgen deprivation therapy (ADT) (luteinising hormone-releasing hormone [LHRH] agonist/antagonist or orchiectomy) with or without androgen receptor pathway inhibitor (ARPI) (pre-enrollment treatment with enzalutamide, abiraterone, apalutamide, or darolutamide are allowed).
• first treatment with ADT should be no longer than 12 weeks before starting the study
• see link to clinicaltrials.gov for complete Inclusion criteria
• history of central nervous system (CNS) metastases
• autoimmune disease requiring systemic treatment in the past 2 years
• prior radiotherapy (to the prostate and/or to all visible metastatic lesions; palliative radiation within 2 weeks prior to first dose of study treatment is allowed
• see link to clinicaltrials.gov for complete Exclusion criteria
An Open-Label Multiple-Dose, 52-Week Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of XYOSTED® for Testosterone Replacement in Male Adolescents (ages: 12 to <18 years) with Conditions Associated with Deficiency or Absence of Endogenous Testosterone Due to Primary or Secondary Hypogonadism (Congenital or Acquired)
This is a study to see if a new drug, named XYOSTED Injection (study drug) will help in the treatment of male adolescents ages 12 to less than 18 years old who have low or no testosterone due to a medical condition called Hypogonadism. Male Hypogonadism is a condition in which the body doesn’t produce enough of the hormone called testosterone that plays a key role in masculine growth and development during puberty. Participation in the study will last 52 weeks.
• 12 to < 18 years of age
• diagnosed with a deficiency or absence of testosterone due to hypogonadism
• if receiving testosterone treatment, must be on a stable dose for at least 12 weeks before starting the study
• body mass index (BMI)-for-age greater than the 5th percentile and weigh at least 40 kg (88 pounds)
• see link to clinicaltrials.gov for complete Inclusion criteria
• suspected or known constitutional growth delay in growth and puberty (CDGP)
• possible nutritional or gastrointestinal disorder that may impact growth
• allergy to foods or products containing sesame seeds or sesame oil
• history of suicidal behavior suicide attempts
• have a history of drug or alcohol abuse
• see link to clinicaltrials.gov for complete Exclusion criteria
A Randomized Phase III Trial Evaluating the Safety and Efficacy of Intraperitoneal IMNN-001 (IL-12 Plasmid Formulated with PEG-PEI-Cholesterol Lipopolymer) Administered in Combination with Standard Neoadjuvant and Adjuvant Chemotherapy in Newly Diagnosed Patients with Advanced Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer (OVATION-3)
The purpose of this research is to learn more about whether IMNN-001 combined with standard chemotherapy is safe and effective for the treatment of advanced ovarian, fallopian tube, or primary peritoneal cancer, compared to standard chemotherapy alone.
• ages 18 years of age or older
• diagnosed with advanced high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer (Stage IIIB/C or IV)
• eligible to receive chemotherapy before surgery
• willing and able to provide a tumor tissue sample for biomarker testing
• see link to clinicaltrials.gov for complete Inclusion criteria
• prior treatment for high-grade ovarian, fallopian tube, or primary peritoneal cancer
• pregnant, breastfeeding, or inability to use required contraception
• see link to clinicaltrials.gov for complete Exclusion criteria
Characterization of spleen motion and anatomy using imaging and sensors
This research is being performed to examine how the spleen moves during breathing in various body positions and breathing conditions. Physical measurements of the participant's body will be recorded (weight, height, and body dimensions) and then noninvasive recordings of the spleen and breathing patterns will be recorded. The spleen motion will be measured using standard abdominal ultrasound imaging, and breathing will be measured with accelerometers (small devices about the size of a quarter that measure the movement of the chest during breathing).
• at least 18 years old
• individuals who have had a splenectomy
• people with breathing difficulties and/or individuals for whom short breath holds and modification of breathing patterns is difficult or uncomfortable
• unable to maintain five body positions: sitting, sitting with a 45 degree recline, laying on back (supine), laying on right side, and laying face down (prone) comfortably and independently
• unable to speak and read English
MT2025-50: An Open-label, Multicenter Phase 1/2 Study to Evaluate the Safety and Efficacy of AB-3028 in Patients with Castration Resistant Prostate Cancer (CRPC)
The main purpose of first part of this study is to see if an experimental cell therapy called AB-3028 is a safe and effective treatment for people with metastatic castration resistant prostate cancer (mCRPC). AB-3028 is a personalized cell therapy made from your own white blood cells. The main goals of the first part are to test the safety of the treatment at different dose levels and find the recommended dose for the second part of the study.
• confirmed adenocarcinoma of the prostate
• progressive metastatic castration-resistant prostate cancer
• prior treatment with at least 1 novel androgen receptor pathway inhibitor (ARPI) therapy
• see link to clinicaltrials.gov for complete Inclusion criteria
• Central nervous system (CNS) metastatic disease, leptomeningeal disease, or spinal cord compression
• unwilling to participate in an extended period of monitoring for side effects
• see link to clinicaltrials.gov for complete Exclusion criteria
A Randomized, Double-Blind, Multicenter, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Atumelnant in Adult Participants with Classic Congenital Adrenal Hyperplasia
The purpose of this research study is to evaluate the safety and effectiveness of a new investigational drug called atumelnant for adults with classic Congenital Adrenal Hyperplasia (CAH) caused by 21-hydroxylase deficiency (21-OHD). Researchers want to learn how well atumelnant helps control CAH symptoms, how the body processes the drug (pharmacokinetics or PK), and whether it produces the expected effects in the body (pharmacodynamics or PD). The study will also evaluate whether participants may be able to reduce their steroid (glucocorticoid) dose while taking atumelnant.
• diagnosis of classical congenital adrenal hyperplasia (CAH)
• on a stable dose of your current steroid (glucocorticoid) treatment
• see link to clinicaltrials.gov for complete inclusion criteria
• diagnosis of any other form of CAH
• are pregnant, breastfeeding, or unable/unwilling to use effective birth control during the study
• see link to clinicaltrials.gov for complete exclusion criteria
A Phase 1a/b Study of ADRX-0405 in Subjects with Select Advanced Solid Tumors
This study aims to evaluate the safety and tolerability of ADRX-0405 in people with advanced cancer and determine the optimal dose for treatment.
• age 18 or older
• Phase 1a: confirmed advanced solid tumors (metastatic castration resistant prostate cancer (mCRPC), gastric cancer (GC), and non-small cell lung cancer (NSCLC))
• Phase 1b: confirmed prostate adenocarcinoma that is confirmed to be castration resistant and that is intolerant/resistant to standard of care (SOC) therapies
• see link to clinicaltrials.gov for complete inclusion criteria
• active and uncontrolled central nervous system metastases
• have received an anticancer or investigational therapy prior to the first dose of study drug
• history of ILD/pneumonitis requiring steroid treatment within the past 2 years, current ILD/pneumonitis, or an active infection requiring systemic antibiotics (prophylactic antibiotics permitted)
• see link to clinicaltrials.gov for complete exclusion criteria
MT2024-25: Allogeneic Hematopoietic Stem Cell Transplant for Patients with High Risk Hemoglobinopathies and Other Red Cell Transfusion Dependent Disorders
This study’s strategy is to take a personalized approach, using a type of donor source combined with a drug regimen specific to that source. The common risks of a transplant approach include graft failure – when the transplant does not take; graft versus host disease (GVHD) – when the transplanted donor cells attack the recipient; and a late effect of infertility. We are studying whether this new approach with conditioning regimen matched with donor source is safer and more effective than our previous approach. Additionally, we are testing whether the dose of radiation will reduce the risk of graft failure.
• 0 to 55 years old
• diagnosis of sickle cell disease (SCD) with transfusion dependent alpha- or beta- thalassemia, diamond blackfan anemia, or other non-malignant hematologic disorders
• sexually active people of childbearing potential or people with partners of childbearing potential must agree to use a highly effective form of contraception during study treatment and for at least 4 months after transplant
• study staff will review additional requirements
• women who are pregnant, breast feeding, or who plan to become pregnant during the study period
• HIV positive
• active uncontrolled infection
MT2026-02: A Phase III, Randomized Study of Daratumumab, Cyclophosphamide, Bortezomib and Dexamethasone (Dara-VCD) Induction Followed by Autologous Stem Cell Transplant or Dara-VCD Consolidation and Daratumumab Maintenance in Patients with Newly Diagnosed AL Amyloidosis (SWOG S2213)
The purpose of this study is to compare two treatment approaches for people with amyloidosis: daratumumab, cyclophosphamide, bortezomib, and dexamethasone (Dara-VCD) chemotherapy followed by an autologous stem cell transplant versus Dara-VCD followed by daratumumab maintenance therapy without a stem cell transplant.
• diagnosis of systemic amyloid light chain (AL) amyloidosis
• may receive up to one cycle (or 28 days) of therapy prior to starting the study
• may be receiving chronic corticosteroids if they are being given for other disorders
• must be willing to undergo high dose chemotherapy and autologous stem cell transplantation
• see link to clinicaltrials.gov for complete inclusion criteria
• women who are pregnant or breastfeeding
• other uncontrolled illnesses including diabetes, hypertension, heart or lung disease
• see link to clinicaltrials.gov for complete exclusion criteria
MT2025-20: A Phase II, multi-part, five-year, randomized, open-label, assessor-blinded, active-controlled, multicenter study to evaluate the efficacy and safety of rapcabtagene autoleucel versus rituximab treatment in participants with severe refractory diffuse cutaneous systemic sclerosis
The goal of this study is to find out if the experimental drug rapcabtagene autoleucel (herein referred to as YTB323), an investigational new therapy, is safe and effective (can help) for people who have severe refractory diffuse cutaneous systemic sclerosis (dcSSc). YTB323 is a chimeric antigen receptor T cell (CAR-T cell) therapy, which is a type of gene therapy or immunotherapy. CAR-T involves collecting and using a patient’s own immune cells, specifically their T cells, to treat their condition.
• 18 to 70 years old
• diagnosis of systemic sclerosis and meet the criteria for diffuse cutaneous (dcSSc)
• Disease onset from the first symptoms attributable to SSc (e.g., puffy hands, scleroderma, digital ulcers, arthralgia, dyspnea) within past 7 years
• severe, progressive systemic sclerosis disease
• see link to clinicaltrials.gov for complete Inclusion criteria
• Rheumatic disease other than dcSSc
• pulmonary hypertension
• significant kidney disease
• uncontrolled hypertension
• see link to clinicaltrials.gov for complete Exclusion criteria
Phase I Clinical Trial of iPSC-Based Therapy (MyoPAXon) for Muscular Dystrophy
This study aims to find out whether MyoPAXon, a genetically modified cellular therapy treatment, is safe to give to patients with Duchenne Muscular Dystrophy (DMD), and whether it has any positive effect on their disease. It will also determine how much MyoPAXon is safe to give to a person at one time.
• diagnosed with Duchenne muscular dystrophy (DMD) and non-ambulatory
• age 18 or older
• off investigational treatments for at least 30 days
• presence of HLA antibodies directed toward HLA antigens on MyoPAXon
• active treatment with another investigational therapy
• known allergy to MyoPAXon components
A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF ALTO-300 WITH AN OPEN-LABEL EXTENSION IN ADULTS WITH MAJOR DEPRESSIVE DISORDER
The purpose of this study is to evaluate the safety and effectiveness of ALTO-300, an investigational medication being studied for adults with Major Depressive Disorder (MDD). This study will compare ALTO-300 to a placebo to learn more about how the medication may improve symptoms of depression and to identify factors that may help predict who is most likely to benefit from treatment.
• ages 18-70 years old
• diagnosed with moderate to severe major depressive disorder (MDD)
• currently taking one approved antidepressant medication (SSRI, SNRI, or bupropion) for at least 6 weeks with no recent dose changes
• diagnosed with fibromyalgia
• pregnant or breastfeeding
A Phase 2, Randomized, Controlled, Multicenter Study of Vosoritide in Children With Idiopathic Short Stature (ISS)
This research is being done to learn if a study drug called vosoritide can help children who are shorter than should be for their age to grow.
• 3 to 10 years old if a girl
• 3 to 11 years old if a boy
• have short stature compared to others of the same gender and age with no known cause
• able to move and stand without help
• known chromosomal imbalance or genetic variant causing short stature syndrome
• previous treatment with a growth promoting agent
COG APEC14B1 The Project: Every Child Protocol: A Registry, Eligibility Screening, Biology and Outcome Study Additional Title: EVERYCHILD (APEC14B1) PCR - COG Foundation
This research trial studies the Project: Every Child for younger patients with cancer. Gathering health information over time from younger patients with cancer may help doctors find better methods of treatment and on-going care.
• must be =< 25 years of age at time of original diagnosis, except for patients who are being screened specifically for eligibility onto a COG (or COG participating National Clinical Trials Network [NCTN]) therapeutic study, for which there is a higher upper age limit
• patients with a known or suspected neoplasm that occurs in the pediatric, adolescent or young adult populations
• enrollment must occur within 6 months of initial disease presentation OR within 6 months of refractory disease, disease progression, disease recurrence, second or secondary malignancy
• see link to clinicaltrials.gov for additional inclusion criteria
PRE-I-SPY TRIAL - PRE-Investigation of Serial Studies to Predict Your Therapeutic Response with Imaging And moLecular Analysis: A Phase I/Ib platform trial (I-SPY)
This study is intended to find the safest dose of a new combination of drugs (ALX148 and T-DXd) and to start to determine how effective it is at treating advanced or metastatic breast cancer. This study is an addition to the ongoing ISPY study program.
• have HER2+ breast cancer
• cancer has spread to other organs or returned within 6 months after first treatment
• active heart or liver disease
• cancer has spread to the brain and is causing current symptoms
MT2025-14: A Phase 1a/1b Study of GTB-5550, a Camelid Nanobody TriSpecific Killer Engager (camB7-H3 TriKE®), in Select Advanced Solid Tumors That Failed Prior Therapy
This study will test GTB-5550, a B7H3-targeted natural killer (NK) cell engager, for the treatment of select solid tumor cancers. The study will determine the optimal dose level and evaluate preliminary safety and efficacy.
• confirmed cancer that can be measured on scans
• fully active, able to care for yourself
• have recovered from side effects of any prior cancer treatments
• have adequate blood counts, kidney, liver, heart, and lung function based on recent lab tests
• see link to clinical trials.gov for complete Inclusion criteria
• recent cancer treatment (within 2 weeks)
• have had a prior organ transplant
• are pregnant or breastfeeding
• another active or recent cancer
• see link to clinicaltrials.gov for complete Exclusion criteria
A pivotal Phase 3, multicenter, randomized, double-blind, placebo-controlled study of the efficacy and safety of DMX-200 in patients with focal segmental glomerulosclerosis (FSGS) who are receiving an angiotensin II receptor blocker (ARB) (ACTION3)
A clinical research study for primary focal segmental glomerulosclerosis (FSGS), or genetic focal segmental glomerulosclerosis (FSGS), or focal segmental glomerulosclerosis (FSGS) of undetermined cause in pediatric (12-17 years) and adult patients. Eligible participants will be assigned to receive either DMX-200 (repagermanium) or placebo (50/50 chance) over a treatment period, with total participation up to 28 month, with potential for participation in an Open Label Extension study period. The main purpose of this study is to see if DMX-200 reduces proteinuria and slows the loss of kidney function in those with FSGS.
• 12-80 years old;
• Primary FSGS, genetic FSGS or FSGS of undetermined cause
• Receiving an ARB, or willing to take one for the study
• see link to clinicaltrials.gov for complete inclusion criteria
• Secondary FSGS
• Not previously treated with standard of care therapies (including steroids)
• Unable to swallow oral medication
• see clinical to clinicaltrials.gov for complete exclusion criteria
MT2025-31: A Phase Ib/II Study of AZD0120, Dual-Targeting Autologous Chimeric Antigen Receptor T-cell (CAR T) Therapy Directed Against CD19 and B-cell Maturation Antigen (BCMA) in Participants With Relapsed/Refractory Multiple Myeloma (DURGA-1)
The purpose of this study is to test a new CAR T-cell therapy called AZD0120 in adults with multiple myeloma that has returned or has not responded to previous treatments. Researchers want to learn whether this therapy is safe, determine the best dose to use, and see how well it works against the cancer. The study will also look at how the treatment affects the immune system and participants’ quality of life.
• diagnosed with multiple myeloma
• have multiple myeloma that has come back or has not responded to treatment
• have received at least 3 prior lines of treatment, including commonly used multiple myeloma therapies
• see link to clinicaltrials.gov for complete inclusion criteria
• had serious side effects from prior CAR T-cell or similar immune-based therapies
• have another active cancer, significant medical condition (such as heart, neurological, mental health, autoimmune, or serious infection-related conditions), or plasma cell leukemia (some exceptions may apply)
• have had a recent stroke, seizure, bleeding in the brain, dementia, or major changes in mental status
• have multiple myeloma affecting the brain or central nervous system
• see link to clinicaltrials.gov for complete exclusion criteria
NRG-GU012: Randomized Phase II Stereotactic Ablative Radiation Therapy (SABR) for Metastatic Unresected Renal Cell Carcinoma (RCC) Receiving Immunotherapy (SAMURAI) (SAMURAI)
The primary purpose of this study is to find out if adding a highly focused form of radiation therapy (called SABR) to the main kidney tumor, along with immunotherapy, helps people with advanced kidney cancer live longer or do better than using immunotherapy by itself.
• diagnosis of renal cell cancer with positive lymph nodes that can't be removed or metastasis to another area
• not recommended for or refused immediate nephrectomy
• must agree to use a highly effective contraception while on study drug and for 6 months following the last dose of study drug
• see link to clinicaltrials.gov for complete inclusion criteria
• untreated or unstable brain metastases
• prior radiotherapy to the kidney
• systemic therapy for metastatic renal cell carcinoma (RCC) that was initiated > 90 days before starting the study
• women who are pregnant or breastfeeding -see link to clinicaltrials.gov for complete exclusion criteria
DCIS: RECAST Trial Ductal Carcinoma In Situ: Re-Evaluating Conditions for Active Surveillance Suitability as Treatment: a breast cancer prevention pilot study
The trial offers women with ductal cell carcinoma in situ (DCIS) 6 months of neoadjuvant exposure to endocrine therapy with the intent of determining their suitability for long-term active surveillance without surgery.
• diagnosis of HR+ DCIS (at least 50% ER or PR (from biopsy at diagnosis) with or without microinvasion
• may have received endocrine therapy
• see link to clinicaltrials.gov for complete Inclusion criteria
• women who are pregnant or breast feeding
• breast cancer is invasive
• unable to swallow tablets or capsules
• gastrointestinal conditions that would interfere with absorption of medication -- see link to clinical trials.gov for complete Exclusion criteria
Zymfentra (Infliximab-dyyb) REal World Cohort STudy (ZEST)
The goal of this study is to learn more about the safety and effectiveness of Zymfentra treatment for people with inflammatory bowel disease (IBD), Crohn’s disease, and ulcerative colitis. Researchers will collect information about symptoms, treatment response, and side effects over time to better understand how Zymfentra works for people with IBD.
• diagnosis of Crohn’s disease (CD), ulcerative colitis (UC), or inflammatory bowel disease unclassified (IBDU)
• starting or switching to Zymfentra treatment for inflammatory bowel disease
COG AALL1732: A Phase 3 Randomized Trial of Inotuzumab Ozogamicin (IND#:133494, NSC#: 772518) for Newly Diagnosed High-Risk B-ALL; Risk-Adapted Post-Induction Therapy for High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and Disseminated B-LLy
• patients must be > 365 days and < 25 years of age
• participant has newly diagnosed B-ALL or MPAL with ≥25% blasts on a bone marrow (BM) aspirate or newly diagnosed B-LLy
• see link to clinicaltrials.gov for complete inclusion criteria
• patients with Down syndrome are not eligible
• patients with acute undifferentiated leukemia (AUL) are not eligible
• female patients who are pregnant, since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required for female patients of childbearing potential
• lactating women who plan to breastfeed their infants while on study and for 2 months after the last dose of inotuzumab ozogamicin.
• see link to clinicaltrials.gov for complete exclusion criteria
A Phase 1, First-in-Human, Dose Escalation and Expansion Study to Evaluate the Safety and Tolerability of XmAb541 in Advanced Solid Tumors
This study is testing an investigational drug called XmAb541 for people with advanced solid tumors that test positive for a protein called CLDN6. XmAb541 is a type of immunotherapy designed to help the body's immune system recognize and attack cancer cells. The first part of the study will test different doses of XmAb541 to determine a safe and appropriate dose for future research. Once a recommended dose is identified, additional participants will receive that dose in the second part of the study. Researchers will evaluate the safety of XmAb541, how the body responds to the treatment, and whether it shows signs of helping to control or shrink cancer.
• ovarian, fallopian tube, peritoneal, endometrial, uterine, or another CLDN6-positive cancer that has returned, spread, or not responded to previous treatment
• able to carry out most daily activities with limited assistance
• see link to ClinicalTrials.gov for complete Inclusion Criteria
• active autoimmune disease
• significant heart, lung, or gastrointestinal disease
• active hepatitis B or hepatitis C infection
• see link to ClinicalTrials.gov for complete Exclusion Criteria
An open, parallel-group, randomized, early feasibility trial to evaluate the initial safety and performance of the INGA catheter in labor induction
The purpose of this study is to evaluate the safety and effectiveness of a new device used during labor induction. We will enroll pregnant adults who are at least 37 weeks pregnant and are scheduled to have labor induced using a balloon catheter. The study will evaluate whether the device can improve monitoring of the pregnant person and baby during labor.
• pregnant adults ages 18–56
• at least 37 weeks pregnant
• pregnant with one baby
• planning to have labor induced using a balloon catheter
• pregnant with more than one baby (twins, triplets, etc.)
• baby is not in a head-down position
• previous cesarean section or other surgery that left a scar on the uterus
• you or your baby need immediate delivery for medical reasons
MT2025-51: A RANDOMIZED, OPEN-LABEL STUDY EVALUATING THE EFFICACY AND SAFETY OF CEMACABTAGENE ANSEGEDLEUCEL IN PARTICIPANTS WITH MINIMAL RESIDUAL DISEASE AFTER RESPONSE TO FIRST LINE THERAPY FOR LARGE B-CELL LYMPHOMA (ALPHA3) (ALPHA3)
This study is for adults with large B-cell lymphoma whose cancer responded to standard treatment but still shows small amounts of disease on a specialized blood test. Participants will be randomly assigned to receive either an investigational CAR T-cell therapy or standard follow-up observation to compare safety and how well each approach helps prevent the lymphoma from returning.
• 18 years of age or older
• diagnosed with certain types of large B-cell lymphoma (LBCL)
• completed standard first-line treatment without needing additional therapy
• cancer is in complete remission or partial remission suitable for observation after first-line treatment
• lymphoma has spread to the brain or spinal cord, or developed from another type of cancer
• previously treated with anti-CD19 therapy
• active autoimmune disease or a serious infection requiring treatment
• another cancer or bone marrow disorder diagnosed within the past 3 years
A PHASE 2 STUDY OF ALISERTIB IN COMBINATION WITH ENDOCRINE THERAPY IN PATIENTS WITH HR+, HER2-NEGATIVE RECURRENT OR METASTATIC BREAST CANCER (ALISCA-Breast1)
The purpose of this study is to see if the study drug, called alisertib, in combination with an ‘endocrine therapy’ such as anastrozole, letrozole, exemestane, tamoxifen or fulvestrant can help people with HR+, HER2-negative recurrent or metastatic breast cancer. The study will also look at how well people tolerate treatment with alisertib in combination with one of the endocrine therapies that are commonly used in clinical practice.
• diagnosis of adenocarcinoma of the breast that has reoccurred of spread to other areas of the body (metastatic)
• treatment with at least two prior lines of endocrine therapy in the recurrent or metastatic setting
• see link to clinicaltrials.gov for complete inclusion criteria
• treatment with chemotherapy in the recurrent or metastatic setting
• see link to clinicaltrials.gov for complete exclusion criteria
Cell free and circulating tumor DNA in the management of muscle invasive bladder cancer, a prospective cohort study.
The goal of this study is to identify the role of cell-free fragments of DNA (cfDNA) and circulating tumor DNA (ctDNA) found in blood and/or urine of patients with bladder cancer in determining whether some patients can avoid chemotherapy and or radical cystectomy. Large numbers of samples need to be analyzed. Participants will be asked to provide additional blood and urine samples; no treatment is provided in this study.
• people who may have invasive bladder cancer
• planning to have a transurethral resection of bladder tumor (TURBT)
• women who are pregnant
• any other active cancer
• at least able to do self care, up and walking & carry out light work or sedentary activity