A Study to Investigate Mocertatug Rezetecan Compared With Standard of Care in Participants With Platinum-resistant Ovarian Cancer (BEHOLD-Ovarian01)

Sponsor
GlaxoSmithKline
Study ID
NCT07286266
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

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
  • Pegylated liposomal doxorubicin (PLD) — DRUG
    PLD will be administered
  • Topotecan — DRUG
    Topotecan will be administered
  • Gemcitabine — DRUG
    Gemcitabine will be administered
  • Pembrolizumab — DRUG
    Pembrolizumab will be administered
  • Bevacizumab — DRUG
    Bevacizumab will be administered

Study Details

This study specifically aims to evaluate how well mocertatug rezetecan (Mo-Rez) works in treating ovarian cancer compared to standard treatments. The study also assesses whether Mo-Rez is safe and tolerated well by participants compared to standard treatments and aims to provide a better understanding of the main side effects of the drug.

Key Dates

Start date
Jun 24, 2026
Status verified
May 2026
Primary completion
Aug 21, 2030
Completion
Aug 21, 2030

Study Design

Enrollment
450 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 chemotherapy (Paclitaxel or Pembrolizumab + paclitaxel ± bevacizumab or PLD or Topotecan or Gemcitabine) as per investigator's choice

Primary Outcome Measure

Progression Free Survival (PFS) by BICR [ Time Frame: Up to approximately 212 weeks ]

Central Contacts

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