A Study of Raludotatug Deruxtecan (R-DXd) in Subjects With Platinum-resistant, High-grade Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

Conditions

• Solid Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• R-DXd — DRUG
  R-DXd will be administered as an intravenously (IV) infusion
• Paclitaxel — DRUG
  Paclitaxel will be administered as an IV infusion
• Topotecan — DRUG
  Topotecan will be administered as an IV infusion
• PLD — DRUG
  PLD will be administered as an IV infusion

Study Details

This study will evaluate the safety and efficacy of R-DXd therapy in participants with ovarian, peritoneal, or fallopian tube cancer.

Key Dates

Start date

Feb 27, 2024

Status verified

May 2026

Primary completion

Feb 29, 2028

Completion

Apr 30, 2030

Study Design

Enrollment

860 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Part A: R-DXd 4.8mg/kg Q3W
  Participants will be randomized to receive intravenous R-DXd administered at a dose of 4.8 mg/kg every 3 weeks (Q3W).
• Experimental: Part A: R-DXd 5.6 mg/kg Q3W
  Participants will be randomized to receive intravenous R-DXd administered at a dose of 5.6 mg/kg every 3 weeks (Q3W).
• Experimental: Part A: R-DXd 6.4 mg/kg Q3W
  Participants will be randomized to receive intravenous R-DXd administered at a dose of 6.4 mg/kg every 3 weeks (Q3W).
• Experimental: Part B: R-DXd RP3D Q3W
  Participants will be randomized to receive intravenous R-DXd administered at the Recommended Phase 3 Dose (RP3D) every 3 weeks (Q3W).
• Active Comparator: Part B: Investigator's Choice
  Participants will be randomized to receive intravenous treatment with investigator's choice of paclitaxel, pegylated liposomal doxorubicin (PLD), or topotecan.

Primary Outcome Measure

Objective Response Rate (ORR) Based on Blinded Independent Central Review (BICR) Assessment (Part A) [ Time Frame: From date of randomization to data cut off, up to 18 months ]

Central Contacts

• Medical Director Contact for Clinical Trial Information
  908-992-6400
  [email protected]

Locations (43)

Find similar trials in Anchorage, AK