CATALINA-2: Study of TORL-1-23 for Treating Platinum-resistant Ovarian Cancer

Inclusion Criteria

• Women aged 18 or older.
• Must agree to and sign an informed consent form.
• Have advanced or metastatic high-grade serous ovarian, primary peritoneal, or fallopian tube cancer, or high-grade endometrioid ovarian cancer.
• Tumor must test positive for CLDN6 expression.
• Cancer must be resistant to platinum-based treatments, meaning it returned or progressed within 3 to 6 months after the last platinum treatment.
• Have received 1 to 3 previous cancer treatments and are suitable for single-agent therapy.
• Have measurable disease according to specific criteria.
• Be in good general health with an ECOG performance status of 0 or 1.
• Have adequate organ function based on specific blood test results.
• Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control during and after the study.
• Agree not to donate eggs or breastfeed during and after the study.

Exclusion Criteria

• Have not fully recovered from side effects of previous cancer treatments.
• Have certain types of ovarian cancer, such as clear cell or mucinous tumors.
• Have cancer that did not respond to initial platinum-based treatment.
• Have received certain cancer treatments recently before starting the study drug.
• Have progressive or symptomatic brain metastases.
• Have significant nerve damage or lung disease.
• Have serious, uncontrolled medical conditions or infections.
• Have significant heart disease or recent heart attack.
• Have a history of certain blood disorders or other cancers within the last 3 years.
• Have a seizure disorder requiring medication.
• Have allergies to the study drugs.
• Have had a bone marrow or organ transplant.
• Are taking certain medications that affect the liver enzyme CYP3A4 or P-glycoprotein.