Giving TORL-1-23 with chemotherapy before initial surgery for advanced ovarian, fallopian tube, and primary peritoneal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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

Where it's running

• Providence St. Jude Medical Center
  Fullerton, California, United States Recruiting
• City of Hope
  Irvine, California, United States Recruiting
• University of Southern California
  Los Angeles, California, United States Recruiting
• UCLA
  Los Angeles, California, United States Recruiting
• The Mayo Clinic
  Rochester, Minnesota, United States Recruiting
• Mt Sinai Hospital
  New York, New York, United States Recruiting

Study contacts

• Study coordinator: Caroline Labib, PharmD
• Email: caroline.labib@torlbio.com
• Phone: 310-348-9636

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.