Clinical trial · Interventional
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
CATALINA-4: Phase 1B/2 Study of TORL-1-23 With Neoadjuvant Chemotherapy and Interval Cytoreductive Surgery in Newly Diagnosed Patients With Advanced Stage Ovarian Cancer
NCT07322094CI-TRIAL-00117766recruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fallopian Tube Cancers | Malignant Fallopian Tube Neoplasm | ALIAS | 0.90 |
| FIGO Stage III and IV Ovarian Cancer | — | UNRESOLVED | — |
| Primary Peritoneal Cancer | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TORL-1-23 and carboplatin | Combination Product | — | UNRESOLVED |
| TORL-1-23 and paclitaxel | Combination Product | — | UNRESOLVED |
| TORL-1-23, paclitaxel, and carboplatin | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Treatment Arm A: TORL-1-23 and paclitaxel
- description
- Administered once every three weeks
- interventionNames
- Combination Product: TORL-1-23 and paclitaxel
- type
- EXPERIMENTAL
- label
- Treatment Arm B: TORL-1-23 and carboplatin
- description
- Administered once every three weeks
- interventionNames
- Combination Product: TORL-1-23 and carboplatin
- type
- EXPERIMENTAL
- label
- Treatment Arm C: TORL-1-23, paclitaxel, and carboplatin
- description
- Administered once every three weeks
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.