TORL-1-23 + Chemotherapy for Ovarian Cancer

Overseen By Caroline Labib, PharmD

Age: 18+

Sex: Female

Trial Phase: Phase 1 & 2

Sponsor: TORL Biotherapeutics, LLC

Must not be taking: Chemotherapy, Biologics, Immunomodulators, others

Disqualifiers: Brain metastases, Uncontrolled conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 24 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Are You a Good Fit for This Trial?

This trial is for women with advanced ovarian cancer, including cancers of the fallopian tubes and peritoneum. Participants must be in stage III or IV, test positive for CLDN6 expression, have a performance status indicating they can perform daily activities with some effort or less (ECOG ≤2), and have organs that are functioning well.

Inclusion Criteria

My cancer is in an advanced stage (III or IV).

My cancer tests positive for CLDN6.

My organs are working well.

Exclusion Criteria

I do not have serious uncontrolled conditions or active infections.

Pregnant or breastfeeding women

My ovarian cancer is of a specific type, not the common kind.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive TORL-1-23 with chemotherapy every three weeks for up to 8 cycles

24 weeks

8 visits (in-person)

Surgery

Interval cytoreductive surgery is performed after neoadjuvant chemotherapy

1 week

Follow-up

Participants are monitored for safety and effectiveness after treatment

15 months

What Are the Treatments Tested in This Trial?

Interventions

• TORL-1-23

Trial Overview

The study tests TORL-1-23 combined with chemotherapy drugs paclitaxel and carboplatin before initial surgery to see if it's safe and effective against advanced ovarian cancer. It's an early-phase trial where patients receive this combination treatment regimen.

How Is the Trial Designed?

Group I: Treatment Arm C: TORL-1-23, paclitaxel, and carboplatin Experimental Treatment 1 Intervention

Administered once every three weeks

Group II: Treatment Arm B: TORL-1-23 and carboplatin Experimental Treatment 1 Intervention

Administered once every three weeks

Group III: Treatment Arm A: TORL-1-23 and paclitaxel Experimental Treatment 1 Intervention

Administered once every three weeks

Who Is Running the Clinical Trial?

TORL Biotherapeutics, LLC

Lead Sponsor

Trials

6

Recruited

600+