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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
Status: Recruiting
This study is being conducted to determine the safest and most effective dose of TORL-1-23 in treating advanced platinum-resistant ovarian cancer.
Sex: Female
Age Group: 18 years and over
Inclusion Criteria:
• 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
Exclusion 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
Interventions:
Drug: Pegfilgrastim (drug), Drug: TORL-1-23, Drug: TORL-1-23, Drug: TORL-1-23
Conditions:
Cancer
Keywords:
Clinics and Surgery Center (CSC), Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cancer
Study Contact: Boris Winterhoff - bwinterh@umn.edu
Principal Investigator: Boris Winterhoff
Phase: PHASE2
IRB Number: STUDY00024234
See this study on ClinicalTrials.gov