West Cancer Center

OVARIAN: PLATINUM RESISTANT: CLAUDIN-6 EXPRESSING: CATALINA-2

Catalina-2: A Phase 2 Study Evaluating the Efficacy and Safety of TORL-1-23 in Women With Advanced Platinum-Resistant Epithelial Ovarian Cancer (Including Primary Peritoneal and Fallopian Tube Cancers) Expressing Claudin 6

Title

TORL Biotherapeutics TORL-1-23 Catalina-2 Ovarian Plt Resistant

Study Title

Site Link

NCT06690775

Malignancy

Ovarian Cancer, Primary Peritoneal Cancer, Fallopian Tube Cancer

Stage

Stage 4

Disease Setting

Metastatic/Palliative

Line Of Therapy

2nd, 3rd, or 4th line

Investigational Agent

TORL-1-23

Drug Class

Claudin 6 ADC

Michael Ulm, MD

Sponsor

TORL Biotherapeutics

Phase

Phase 2

Status

Open to Enrollment

Key Eligibility Criteria

Key Eligibility Criteria Details

Histologically or cytologically confirmed diagnosis of advanced (unresectable) or metastatic high grade serous ovarian, primary peritoneal, or fallopian tube cancer. High-grade endometrioid ovarian cancer is permitted, Carcinosarcoma is permitted
Positive CLDN6 expression as per central lab
Platinum resistant disease as per protocol
Patients who are platinum refractory during front-line treatment are excluded
Must have received at least 1 but no more than 3 prior systemic lines of anticancer therapy and for whom single-agent therapy is appropriate as next line
- Adjuvant or neoadjuvant therapy is counted as one line
Measurable disease
ECOG PS 0-1
Must have recovered from acute effects of prior therapy
No clear cell, mucinous, sarcomatous, mixed histology, or low grade, borderline ovarian tumors or non-epithelial ovarian cancers
No prior cancer within 3 years

Objective

Primary
- ORR
Secondary
- DoR
- Investigator ORR
- PFS
- OS
- AEs
- CA-125 response

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

Epithelial

Dosing Frequency

Control Agents

Study Protocol

Randomized

Yes