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

Part of paid clinical trials in Fullerton, California.

Sponsor
TORL Biotherapeutics, LLC
Study ID
NCT07322094
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • FIGO Stage III and IV Ovarian Cancer
  • Fallopian Tube Cancers
  • Primary Peritoneal Cancer

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • TORL-1-23 and paclitaxel — COMBINATION_PRODUCT
    TORL-1-23 and paclitaxel
  • TORL-1-23 and carboplatin — COMBINATION_PRODUCT
    TORL-1-23 and carboplatin
  • TORL-1-23, paclitaxel, and carboplatin — COMBINATION_PRODUCT
    TORL-1-23, paclitaxel, and carboplatin

Study Details

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

Key Dates

First listed
Jan 7, 2026
Start date
Dec 10, 2025
Status verified
Jul 2026
Primary completion
Dec 31, 2027
Completion
Jan 31, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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

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) ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Providence St. Jude Medical CenterFullertonCalifornia92835-
City of HopeIrvineCalifornia92618-
UCLALos AngelesCalifornia90095
Principal Investigator
310-348-9636
University of Southern CaliforniaLos AngelesCalifornia90007-
The Mayo ClinicRochesterMinnesota55905-
Mt Sinai HospitalNew YorkNew York10029-
Duke UniversityDurhamNorth Carolina27705-

Find similar trials in Fullerton, CA

By research site
Providence St. Jude Medical Center· Fullerton, CACity of Hope· Irvine, CAUCLA· Los Angeles, CAUniversity of Southern California· Los Angeles, CAThe Mayo Clinic· Rochester, MNMt Sinai Hospital· New York, NY

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