Giving TORL-1-23 with chemotherapy before initial surgery for advanced ovarian, fallopian tube, and primary peritoneal cancer
CATALINA-4: Phase 1B/2 Study of TORL-1-23 With Neoadjuvant Chemotherapy and Interval Cytoreductive Surgery in Newly Diagnosed Patients With Advanced Stage Ovarian Cancer
This study will test whether adding TORL-1-23 to standard paclitaxel and carboplatin before initial surgery helps women with advanced (FIGO III/IV) ovarian, fallopian tube, or primary peritoneal cancer whose tumors are CLDN6-positive.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | Female |
| Sponsor | TORL Biotherapeutics, LLC Industry-sponsored |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT07322094 on ClinicalTrials.gov |
What this trial studies
This is a Phase 1b/2 neoadjuvant trial adding the investigational agent TORL-1-23 to standard paclitaxel and carboplatin and giving the combination before initial (debulking) surgery. The Phase 1b portion will focus on safety and selecting the recommended dose when combined with chemotherapy, and the Phase 2 portion will look for signs of anti-tumor activity and surgical outcomes. Eligible participants are treatment-naïve women with FIGO stage III or IV epithelial ovarian, fallopian tube, or primary peritoneal cancer that tests positive for CLDN6 and who have adequate organ function and ECOG ≤2. Key exclusions include certain histologies (clear cell, mucinous, low-grade/borderline, non-epithelial), prior systemic therapy or prior abdominal/pelvic radiation, active brain metastases, and pregnancy or breastfeeding.
Who should consider this trial
Good fit: Women with newly diagnosed FIGO stage III or IV epithelial ovarian, fallopian tube, or primary peritoneal cancer with CLDN6-positive tumors, ECOG performance status 0–2, no prior systemic treatment or surgery, and adequate organ function are the ideal candidates.
Not a fit: Patients with excluded histologies (clear cell, mucinous, sarcomatous, mixed, low-grade/borderline, or non-epithelial), prior systemic therapy or prior surgery, CLDN6-negative tumors, active uncontrolled medical conditions, brain metastases, or who are pregnant/breastfeeding are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the combination could increase tumor shrinkage before surgery and improve the chances for a more complete surgical removal of cancer.
How similar studies have performed: CLDN6-targeted therapies are a relatively new approach with only limited early-phase signals of activity reported, so this is an early clinical test of this specific agent and combination.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2. * 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 chemotherapy, biologic/targeted therapy, immunomodulator therapy for any disease indication * 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
Where this trial is running
Los Angeles, California
- UCLA — Los Angeles, California, United States (Recruiting)
Study contacts
- Study coordinator: Caroline Labib, PharmD
- Email: caroline.labib@torlbio.com
- Phone: 310-348-9636
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.