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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

ConditionsFIGO Stage III and IV Ovarian CancerFallopian Tube CancersPrimary Peritoneal Cancer
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorTORL Biotherapeutics, LLC

About 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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2.

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

60 Participants
are divided into 3 treatment groups
Group A: Treatment Arm A: TORL-1-23 and paclitaxelExperimental treatment 1 intervention
Group B: Treatment Arm B: TORL-1-23 and carboplatinExperimental treatment 1 intervention
Group C: Treatment Arm C: TORL-1-23, paclitaxel, and carboplatinExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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)

Time frame
Treatment during Cycle 1 to Cycle 4 (Each cycle is 21 days)
2

To assess the efficacy of neoadjuvant TORL-1-23 in combination with chemotherapy

Determination of percentage CRS3 score for each treatment arm

Time frame
postoperative after Cycle 4 (Each cycle is 21 days)

Secondary outcomes

1

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

Safety assessed by incidence of intolerable Grade 2 and Grade greater than or equal to 3 TEAE and related SAE.

Time frame
Treatment up to Cycle 8 (each cycle is 21 days)
2

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

Relapse free survival for participants

Time frame
Measured up to 15 months after surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

TORL Biotherapeutics, LLC

Lead sponsor

Source ClinicalTrials.gov
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