NCT07322094 CATALINA-4: A Study to Investigate the Safety and Efficacy of TORL-1-23 With Chemotherapy Given Before Initial Surgery in Women With Advanced Stage Ovarian Cancer
| NCT ID | NCT07322094 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | TORL Biotherapeutics, LLC |
| Condition | FIGO Stage III and IV Ovarian Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-12-10 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 60 participants in total. It began in 2025-12-10 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
A Phase 1B/2 Study to Investigate the Safety and Efficacy of TORL-1-23 with Chemotherapy Given Before Initial Surgery in Women with Advanced Stage Ovarian Cancer
Eligibility Criteria
Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1 * Histologically or cytologically confirmed diagnosis of epithelial ovarian, primary peritoneal or fallopian tubes cancer * FIGO Stage III or IV * Positive for claudin 6 (CLDN6) expression * Adequate organ function Exclusion Criteria: * Clear cell, mucinous, sarcomatous, mixed histology, low-grade/borderline, or non-epithelial ovarian cancers * Prior systemic treatment for the disease under study * Prior surgery * Prior radiation therapy to the abdomen or pelvis * Current recipient or receipt within 5-half-lives of C1D1 of any of the following: chemotherapy, biologic/targeted therapy, herbal medications or supplements, immunomodulator therapy for any disease indication. * History of noninfectious pneumonitis/interstitial lung disease (ILD) within 6 months of first dose of study drug. * Active, progressive, or symptomatic brain metastases * Participants considered poor medical risks due to serious, uncontrolled medical conditions, active infections, or nonmalignant systemic diseases * Pregnant or breastfeeding women
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07322094 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 75 Years, studying FIGO Stage III and IV Ovarian Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07322094 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07322094 currently recruiting?
Yes, NCT07322094 is actively recruiting participants. Contact the research team at caroline.labib@torlbio.com for enrollment information.
Where is the NCT07322094 trial being conducted?
This trial is being conducted at Fullerton, United States, Irvine, United States, Los Angeles, United States, Los Angeles, United States and 3 additional locations.
Who is sponsoring the NCT07322094 clinical trial?
NCT07322094 is sponsored by TORL Biotherapeutics, LLC. The trial plans to enroll 60 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.