A Study to Investigate Mocertatug Rezetecan Compared With Chemotherapy in Participants With Endometrial Cancer After Platinum-based Chemotherapy and Immunotherapy (BEHOLD-Endometrial01)

Conditions

• Neoplasms, Endometrial

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Mocertatug rezetecan — DRUG
  Mocertatug rezetecan will be administered
• Paclitaxel — DRUG
  Paclitaxel will be administered
• Doxorubicin — DRUG
  Doxorubicin will be administered

Study Details

This study specifically aims to evaluate how well mocertatug rezetecan (Mo-Rez) works in treating Endometrial Cancer (EC) compared to standard of care. The study also assesses whether Mo-Rez is safe and tolerated well by participants in comparison to standard of care and will help provide a better understanding of the main side effects of the drugs.

Key Dates

First listed

Dec 16, 2025

Start date

Jun 4, 2026

Status verified

Sep 2026

Primary completion

Feb 29, 2028

Completion

May 30, 2029

Study Design

Enrollment

600 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Mocertatug rezetecan
  Participants will receive Mocertatug rezetecan
• Active Comparator: Standard of Care
  Participants will receive standard of care treatment (Paclitaxel or Doxorubicin) as per investigator's discretion

Primary Outcome Measure

Objective response rate (ORR) by BICR [ Time Frame: Up to approximately 97 weeks ]

Central Contacts

• US GSK Clinical Trials Call Center
  877-379-3718
  [email protected]
• EU GSK Clinical Trials Call Center
  +44 (0) 20 89904466
  [email protected]

Locations (2)

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