NCT07322094

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
17mo left

Started Dec 2025

Typical duration for phase_1

Geographic Reach
1 country

7 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress32%
Dec 2025Jan 2028

Study Start

First participant enrolled

December 10, 2025

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

December 17, 2025

Completed
21 days until next milestone

First Posted

Study publicly available on registry

January 7, 2026

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2028

Last Updated

July 13, 2026

Status Verified

July 1, 2026

Enrollment Period

2 years

First QC Date

December 17, 2025

Last Update Submit

July 9, 2026

Conditions

Fallopian Tube CancersFIGO Stage III and IV Ovarian CancerPrimary Peritoneal Cancer

Outcome Measures

Primary Outcomes (2)

  • 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.

    Incidence of Grade greater than or equal to 3 (using CTCAE V5.0) treatment-emergent adverse event (TEAE) and related serious adverse event (SAE)

    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

    Determination of percentage CRS3 score for each treatment arm

    postoperative after Cycle 4 (Each cycle is 21 days)

Secondary Outcomes (2)

  • To assess the tolerability of TORL-1-23 in combination with chemotherapy

    Treatment up to Cycle 8 (each cycle is 21 days)

  • To characterize duration of benefit for TORL-1-23 plus chemotherapy

    Measured up to 15 months after surgery

Study Arms (3)

Treatment Arm A: TORL-1-23 and paclitaxel

EXPERIMENTAL

Administered once every three weeks

Combination Product: TORL-1-23 and paclitaxel

Treatment Arm B: TORL-1-23 and carboplatin

EXPERIMENTAL

Administered once every three weeks

Combination Product: TORL-1-23 and carboplatin

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

EXPERIMENTAL

Administered once every three weeks

Combination Product: TORL-1-23, paclitaxel, and carboplatin

Interventions

TORL-1-23 and paclitaxelCOMBINATION_PRODUCT

TORL-1-23 and paclitaxel

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

TORL-1-23 and carboplatin

Treatment Arm B: TORL-1-23 and carboplatin
TORL-1-23, paclitaxel, and carboplatinCOMBINATION_PRODUCT

TORL-1-23, paclitaxel, and carboplatin

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

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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 the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Providence St. Jude Medical Center

Fullerton, California, 92835, United States

RECRUITING

City of Hope

Irvine, California, 92618, United States

RECRUITING

University of Southern California

Los Angeles, California, 90007, United States

RECRUITING

UCLA

Los Angeles, California, 90095, United States

RECRUITING

The Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

Mt Sinai Hospital

New York, New York, 10029, United States

RECRUITING

Duke University

Durham, North Carolina, 27705, United States

RECRUITING

MeSH Terms

Conditions

Fallopian Tube Neoplasms

Interventions

PaclitaxelCarboplatin

Condition Hierarchy (Ancestors)

Genital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFallopian Tube DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesCoordination Complexes

Central Study Contacts

Caroline Labib, PharmD

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2025

First Posted

January 7, 2026

Study Start

December 10, 2025

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

January 1, 2028

Last Updated

July 13, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

US(7)