Clinical Trials in the USA / NCT07322094
Recruiting
Phase 1/2
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
NCT07322094 · tracked via the Priya Life Science USA tracker
Condition(s) studied
FIGO Stage III and IV Ovarian CancerFallopian Tube CancersPrimary Peritoneal Cancer
Investigational drug(s) / intervention(s)
TORL-1-23 and paclitaxelTORL-1-23 and carboplatinTORL-1-23, paclitaxel, and carboplatin
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
Study 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
Eligibility
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
Primary outcome measure(s)
- 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. — Treatment during Cycle 1 to Cycle 4 (Each cycle is 21 days)
Incidence of Grade greater than or equal to 3 (using CTCAE V5.0) treatment-emergent adverse event (TEAE) and related serious adverse event (SAE) - To assess the efficacy of neoadjuvant TORL-1-23 in combination with chemotherapy — postoperative after Cycle 4 (Each cycle is 21 days)
Determination of percentage CRS3 score for each treatment arm
Trial sites (7)
| Facility | City | Region | Status |
|---|---|---|---|
| Providence St. Jude Medical Center | Fullerton | California | Recruiting |
| City of Hope | Irvine | California | Recruiting |
| University of Southern California | Los Angeles | California | Recruiting |
| UCLA | Los Angeles | California | Recruiting |
| The Mayo Clinic | Rochester | Minnesota | Recruiting |
| Mt Sinai Hospital | New York | New York | Recruiting |
| Duke University | Durham | North Carolina | Recruiting |
More TORL Biotherapeutics, LLC trials in the USA
A Phase 1, First in Human Study of TORL-4-500 in Patients With Advanced Cancer
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First in Human Study of TORL-2-307-ADC in Participants With Advanced Cancer
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First in Human Study of TORL-3-600 in Participants With Advanced Cancer
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Other trials for the same condition
Study of IMNN-001 (Also Known as GEN-1) With NACT for Treatment of Ovarian Cancer (OVATION 2)
Active, not recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07322094 on ClinicalTrials.gov ↗ ← All trials in the USA