Recruiting
Phase 1
Phase 2

TORL-1-23 with Chemotherapy

Sponsor:

TORL Biotherapeutics, LLC

Code:

NCT07322094

Conditions

FIGO Stage III and IV Ovarian Cancer

Fallopian Tube Cancers

Primary Peritoneal Cancer

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

TORL-1-23 and paclitaxel

TORL-1-23 and carboplatin

TORL-1-23, paclitaxel, and carboplatin

Study Details

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

Conditions

FIGO Stage III and IV Ovarian Cancer

Fallopian Tube Cancers

Primary Peritoneal Cancer

Study ID

NCT07322094

Start date

Dec 10, 2025

Status verified date

Jul, 2026

Completion date

Jan, 2028

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment Arm A: TORL-1-23 and paclitaxel

Administered once every three weeks

experimental: Treatment Arm B: TORL-1-23 and carboplatin

Administered once every three weeks

experimental: Treatment Arm C: TORL-1-23, paclitaxel, and carboplatin

Administered once every three weeks

Interventions

TORL-1-23 and paclitaxel

TORL-1-23 and paclitaxel

TORL-1-23 and carboplatin

TORL-1-23 and carboplatin

TORL-1-23, paclitaxel, and carboplatin

TORL-1-23, paclitaxel, and carboplatin

Primary outcome measure

  • Characterize the safety and feasibility of TORL-1-23 in combination with chemotherapy by analyzing the incidence of treatment emergent adverse events and serious adverse events. [ Time Frame: Treatment during Cycle 1 to Cycle 4 (Each cycle is 21 days) ]
  • To assess the efficacy of neoadjuvant TORL-1-23 in combination with chemotherapy [ Time Frame: postoperative after Cycle 4 (Each cycle is 21 days) ]

Central Contacts and Locations

Central contacts

Caroline Labib, PharmD

310-348-9636caroline.labib@torlbio.com

Locations

Providence St. Jude Medical Center

Recruiting

Fullerton, California, United States, 92835

City of Hope

Recruiting

Irvine, California, United States, 92618

University of Southern California

Recruiting

Los Angeles, California, United States, 90007

UCLA

Recruiting

Los Angeles, California, United States, 90095

Contacts

Principal Investigator

310-348-9636

The Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Mt Sinai Hospital

Recruiting

New York, New York, United States, 10029

Duke University

Recruiting

Durham, North Carolina, United States, 27705

More Information

Sponsor

TORL Biotherapeutics, LLC

Last update posted

Jul 13, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by TORL Biotherapeutics, LLC on 2026-07-13.