A Study to Test the Safety and Effectiveness of GSK5764227, Alone or With Other Treatments, in Participants With Advanced Gastrointestinal Cancers That Cannot be Surgically Removed (EMBOLD PanGI-201)

StatusRecruiting
PhasePhase 1/2
Started

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Trial flagged as At Risk
Primary completion moved at least 11 months later Jan 10, 2028 → Jan 9, 2029
Enrollment reduced 23% 451 → 346 participants
See other at-risk trials from GlaxoSmithKline

Record History

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  1. Primary completion pushed from Jan 10, 2028 to Jan 9, 2029 Show 6 more changesShow less
    • Enrollment reduced: 451 → 346 participants
    • Interventions modified
    • Trial arms changed: 9 → 6
    • Eligibility criteria expanded, about 19 words
    • Secondary endpoints revised (30)
    • Site details revised at 24 of 85 sites
  2. Trial arms changed: 5 → 9v9 Show 5 more changesShow less
    • Interventions: GSK5764227 (Biological) to Drug 1 (Drug), Drug 2 (Drug), Drug 3 (Drug), Drug 4 (Drug), Risvutatug Rezetecan (Biological)
    • Eligibility criteria shortened, about 429 words
    • Secondary endpoints revised (30)
    • Site details revised at 1 of 85 sites
    • Study title expanded, about 2 words
  3. Enrollment target: 320 to 451
    • Study sites: 47 to 85
    • Primary completion date: Nov 11, 2027 to Jan 10, 2028
    • Study completion date: Jun 23, 2028 to Jan 9, 2029
    v8
  4. Study sites: 12 to 47v7
  5. Study sites: 7 to 12
    • Eligibility criteria expanded, about 84 words
    • Secondary endpoints revised (30)
    • Study arms: 2 to 5
    v6
Show 4 earlier versionsHide 4 earlier versions
  1. Enrollment target: 200 to 320
    • Primary completion date: Nov 11, 2026 to Nov 11, 2027
    • Study sites: 6 to 7
    • Study completion date: Feb 21, 2028 to Jun 23, 2028
    v5
  2. Trial status: Not Yet Recruiting to Recruitingv4 Show 5 more changesShow less
    • Enrollment target: 120 to 200
    • Study sites: 0 to 6
    • Primary completion date: Nov 30, 2026 to Nov 11, 2026
    • Study completion date: Mar 9, 2028 to Feb 21, 2028
    • Start date changed from estimate of Jun 30, 2025 to Jun 11, 2025
  3. Secondary endpoints revised (30)v3
  4. Enrollment target: 627 to 120v2
  1. 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.
This study will check how well a new medicine, Risvutatug rezetecan, (Ris-Rez, also known as GSK5764227) works, how safe it is and how the body handles it in participants all around the world with advanced inoperable or metastatic gastrointestinal cancer who have previously received treatment.
Trial Details
NCT Number NCT06885034
Lead Sponsor GlaxoSmithKline
Conditions
(from sponsor)		 Gastrointestinal Neoplasms
Related terms Colorectal Neoplasms, Gastrointestinal Neoplasms
Enrollment 346 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov