What is TORL-1-23 studying for advanced ovarian cancer?

TORL-1-23 is being studied to evaluate its safety and effectiveness in women with advanced platinum-resistant ovarian cancer expressing Claudin 6. The research aims to better understand how this treatment works in patients whose cancer has not responded well to prior platinum-based chemotherapy. TORL Biotherapeutics, LLC is sponsoring this clinical trial to explore new options for this challenging condition.

Who may be eligible for this ovarian cancer clinical trial?

Women 18 years or older with advanced platinum-resistant ovarian, primary peritoneal, or fallopian tube cancer that expresses Claudin 6 may be eligible. Participants should have received 1 to 3 prior systemic anticancer therapies and have measurable disease with good organ function. Please review eligibility criteria for more details.

Is there any cost to participate in this ovarian cancer clinical trial?

Study-related care, including the study drugs and all trial visits, is provided at no cost. Personal travel expenses and other related costs may vary and are typically not covered by the study. Participants should plan accordingly for any out-of-pocket expenses.

Actively Recruiting

Phase 2

Age: 18Years +

FEMALE

ID06690775

Phase 2 Study of TORL-1-23 Treatment for Advanced Platinum-Resistant Ovarian and Related Cancers in Women Expressing Claudin 6

Led by TORL Biotherapeutics, LLC · Updated on 2025-12-23

230

Participants Needed

Research Sites

8 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and effectiveness of TORL-1-23 in women with advanced platinum-resistant epithelial ovarian cancer, including primary peritoneal and fallopian tube cancers that express Claudin 6. This Phase 2 study focuses on patients whose cancer has not responded well to platinum-based chemotherapy and aims to understand how this treatment works in this population. The study involves three groups receiving different doses of TORL-1-23 given as an intravenous infusion on Day 1 of every 21-day cycle. Alongside TORL-1-23, participants receive pegfilgrastim by subcutaneous injection on Day 4 of each cycle to support their immune system. Each treatment cycle lasts three weeks, and all participants follow this schedule throughout the study period. Participants will be monitored regularly with scans and lab tests to measure how their cancer responds to treatment, including progression-free survival and overall survival. Safety will be checked by recording side effects and laboratory abnormalities from the start of treatment until 30 days after the last dose. The study will last about 40 months, during which disease progression and other outcomes will be tracked at set intervals to assess the treatments effects.

CONDITIONS

Brief Title

CATALINA-2: A Clinical Study of TORL-1-23 in Platinum-resistant Ovarian Cancer.

Who Can Participate

Age: 18Years +

FEMALE

Eligibility Criteria

You may qualify if you...

Female aged 18 years or older at time of consent
Signed informed consent including protocol compliance
Histologically or cytologically confirmed advanced or metastatic high-grade serous ovarian, primary peritoneal, or fallopian tube cancer, including high-grade endometrioid ovarian cancer
Tumor positive for CLDN6 expression confirmed by reference laboratory
Platinum-resistant disease as defined by progression timeline after platinum therapy
Received 1 to 3 prior systemic anticancer therapies with single-agent therapy appropriate next
Measurable disease per RECIST v1.1
ECOG performance status 0-1
Adequate organ function including ANC ≥1500/mcL, platelets ≥100,000/mcL, hemoglobin ≥9 g/dL, creatinine clearance ≥30 mL/min, bilirubin ≤1.5x ULN (exceptions allowed), AST/ALT ≤3x ULN (exceptions allowed), albumin ≥2.5 g/dL, and normal or non-significant ECG
Negative serum pregnancy test within 72 hours before treatment if of childbearing potential
Agree to use effective birth control from first dose through 7 months after last dose or be nonchildbearing
Agree not to donate eggs from first dose through 7 months after last dose
Agree not to breastfeed from first dose through 90 days after last dose

You will not qualify if you...

Not recovered from acute toxicities of prior therapy except alopecia or eligible lab abnormalities
Clear cell, mucinous, sarcomatous, mixed histology, low-grade, borderline ovarian tumors or non-epithelial ovarian cancers
Primary platinum-refractory disease defined as progression within 3 months of first-line platinum therapy
Prior chemotherapeutic, investigational, radiotherapy, or other cancer treatments within 14 days (small molecules) or 28 days (biologics) before first dose
Prior treatment with CLDN6-targeting agents or MMAE-containing ADCs
Progressive or symptomatic brain metastases (stable radiated brain metastases allowed)
Grade 2 or greater peripheral neuropathy
History of non-infectious pneumonitis or interstitial lung disease within 6 months
High medical risk from serious uncontrolled disorders or infections
Significant cardiac disease including recent heart failure, unstable angina, recent myocardial infarction, untreated arrhythmia
History of myelodysplastic syndrome or acute myeloid leukemia
Other cancers within 3 years except treated basal or squamous cell skin cancer or low recurrence risk malignancies
Uncontrolled active infections (CTCAE Grade >2)
Seizure disorder requiring medication
Known hypersensitivity to study drugs or excipients
History of allogeneic bone marrow or organ transplant
Any condition interfering with study participation or safety
Use of strong CYP3A4 enzyme inducers/inhibitors or P-glycoprotein inhibitors

Research Team

Hatem Dokainish, PhD

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Phase 2 Study of TORL-1-23 Treatment for Advanced Platinum-Resistant Ovarian and Related Cancers in Women Expressing Claudin 6

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria