CATALINA-2: A Clinical Study of TORL-1-23 in Platinum-resistant Ovarian Cancer.

Conditions

• Endometrioid Ovarian Cancer
• Epithelial Ovarian Cancer
• Fallopian Tube Cancer
• Primary Peritoneal

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• TORL-1-23 — DRUG
  2.4mg/kg intravenous infusion on Day 1 of every 3-week cycle.
• TORL-1-23 — DRUG
  3.0 mg/kg intravenous infusion on Day 1 of every 3-week cycle.
• TORL-1-23 — DRUG
  3.4 mg/kg intravenous infusion on Day 1 of every 3-week cycle.
• Pegfilgrastim (drug) — DRUG
  6.0 mg subcutaneous injection on Day 4 of each cycle.

Study Details

A Phase 2 study to evaluate the safety and efficacy of TORL-1-23 in patients with advanced ovarian cancer.

Key Dates

Start date

Nov 20, 2024

Status verified

Dec 2025

Primary completion

Oct 31, 2027

Completion

Dec 31, 2027

Study Design

Enrollment

230 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Cohort 1
  Participants will receive TORL-1-23 on Day 1 of each 21-day cycle. Additionally, pegfilgrastim will be administered on Day 4 of each 21-day cycle.
• Experimental: Cohort 2
  Participants will receive TORL-1-23 on Day 1 of each 21-day cycle. Additionally, pegfilgrastim will be administered on Day 4 of each 21-day cycle.
• Experimental: Cohort 3
  Participants will receive TORL-1-23 on Day 1 of each 21-day cycle. Additionally, pegfilgrastim will be administered on Day 4 of each 21-day cycle.

Primary Outcome Measure

To assess the efficacy of TORL-1-23 as a monotherapy in women with advanced PROC expressing CLDN6 [ Time Frame: At predefined intervals from Dose 1 until documented disease progression, total overall study duration approximately 40 months ]

Central Contacts

• Hatem Dokainish, PhD
  310-348-9636
  [email protected]

Locations (26)

Find similar trials in Phoenix, AZ

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