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Ovarian, Cervical CancerOpen to EnrollmentPhase 2

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

Study snapshot

Title
TORL Biotherapeutics TORL-1-23 Catalina-2 Ovarian Plt Resistant
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
Principal investigator
Michael Ulm, MD
Sponsor
TORL Biotherapeutics
Path
Epithelial
Randomized
Yes
ClinicalTrials.gov ID
NCT06690775

Eligibility and objectives

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

Treatment details