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TORL-1-23 in platinum-resistant ovarian cancer
NCT06690775Phase 2
Key facts
- Status
- Recruiting
- Start
- Nov 2024
- Primary completion
- Oct 2027
- Countries
- 12
- Sponsor
- TORL BioTherapeutics
- Modality
- Antibody-Drug Conjugates (ADCs)
- Drugs
- ixotatug vedotin
- Conditions
- epithelial ovarian cancer (EOC)primary peritoneal cancer (PPC)fallopian tube cancer (PFTC)
01
Overview
Phase 2, open-label trial of ixotatug vedotin in epithelial ovarian cancer (EOC), primary peritoneal cancer (PPC) and fallopian tube cancer (PFTC) (3 cohorts), sponsored by TORL BioTherapeutics. Primary endpoint: Efficacy of TORL-1-23 as monotherapy at 40 months. Started Nov 2024; status: recruiting.
02
Design
3 arms- Study design
- Non-randomizedOpen-label
Cohort 1
TORL-1-23 2.4 mg/kg + pegfilgrastim
Cohort 2
TORL-1-23 3.0 mg/kg + pegfilgrastim
Cohort 3
TORL-1-23 3.4 mg/kg + pegfilgrastim
03
Who it enrols
Women ≥18 years with advanced platinum-resistant high-grade serous ovarian, primary peritoneal, or fallopian tube cancer (or high-grade endometrioid ovarian cancer) expressing CLDN6, with 1-3 prior lines of therapy, ECOG 0-1, measurable disease, and adequate organ function
04
Endpoints
Primary
Efficacy of TORL-1-23 as monotherapy
Secondary
Duration of Response
Objective Response Rate
Progression-Free Survival
Overall Survival
Adverse Events
CA-125 Response per GCIG Criteria
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