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

StatusRecruiting
PhasePhase 3
Started

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Trial flagged as At Risk
Primary completion moved at least 7 months later Dec 17, 2029 → Jul 22, 2030
See other at-risk trials from GlaxoSmithKline

Record History

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  1. Primary and study completion pushed from Dec 17, 2029 to Jul 22, 2030
  2. Trial sites expanded: 5 → 22 locations
    • Eligibility criteria expanded, about 45 words
    • Secondary endpoints: details revised at 6 of 18 entries
  3. Primary and study completion moved earlier from Aug 21, 2030 to Dec 17, 2029
    • Site details revised at 1 of 5 sites
    • Collaborators: 3 to 1
    v5
  4. Recruitment opened
    • Trial sites expanded: 0 → 5 locations
    • Start date changed from estimate of Jun 24, 2026 to Jun 18, 2026
    v4
  5. Primary and study completion pushed from Jul 22, 2030 to Aug 21, 2030v3 Show 5 more changesShow less
    • Interventions: GSK5733584 (Drug), Gemcitabine (Drug), Paclitaxel (Drug), Pegylated liposomal doxorubicin (PLD) (Drug), Topotecan (Drug) to Bevacizumab (Drug), Gemcitabine (Drug), Mocertatug rezetecan (Drug), Paclitaxel (Drug), Pegylated liposomal doxorubicin (PLD) (Drug)…
    • Eligibility criteria expanded, about 374 words
    • Secondary endpoints revised (18)
    • Collaborators: 2 to 3
    • Study title expanded, about 3 words
  6. Primary and study completion dates: Jan 16, 2030 to Jul 22, 2030
    • Start date: Mar 3, 2026 to Jun 24, 2026
    v2
  7. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
GlaxoSmithKline
246 trials monitored
See 20 trials at risk
Ovarian Cancer
1,341 trials monitored
See 94 trials at risk
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.
Trial Details
NCT Number NCT07286266
Lead Sponsor GlaxoSmithKline
Collaborators: GOG, ENGOT, APGOT
Conditions
(from sponsor)		 Ovarian Neoplasms
Related terms Ovarian Neoplasms
Enrollment 450 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov