First-Time-in-Human Study of GSK4381562 in Participants With Advanced Solid Tumors

StatusActive, Not Recruiting
PhasePhase 1
Started

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Record History

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  1. Primary completion date changed from estimate of Aug 31, 2027 to Jun 30, 2026
    • Eligibility criteria expanded, about 30 words
    • Secondary endpoints: details revised at 4 of 92 entries
    • Site details revised at 3 of 26 sites
  2. 2 versions Re-verified since May 21, 2026, no change to tracked fieldsv13-v14
  3. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 158 to confirmed 152
    • Site details revised at 26 of 26 sites
    v12
  4. Interventions: Belrestotug (Drug), Dostarlimab (Drug), GSK4381562 (Drug), GSK5764227 (Drug), Nelistotug (Drug) to Belrestotug (Drug), Dostarlimab (Drug), GSK5764227 (Drug), Nelistotug (Drug), Remzistotug (Drug)
    • Secondary endpoints: 102 to 92
    • Site details revised at 1 of 26 sites
    • Study arms: 9 to 8
    v11
  5. Primary and study completion dates: Sep 12, 2028 to Aug 31, 2027
    • Enrollment target: 141 to 158
    • Study sites: 24 to 26
    v10
Show 8 earlier versionsHide 8 earlier versions
  1. Primary and study completion dates: Oct 14, 2026 to Sep 12, 2028v9 Show 7 more changesShow less
    • Primary endpoints revised (2)
    • Enrollment target: 162 to 141
    • Study sites: 23 to 24
    • Interventions: Dostarlimab (Drug), GSK4381562 (Drug), GSK4428859A (Drug) to Belrestotug (Drug), Dostarlimab (Drug), GSK4381562 (Drug), GSK5764227 (Drug), Nelistotug (Drug)
    • Eligibility criteria expanded, about 42 words
    • Secondary endpoints: 29 to 102
    • Study arms: 4 to 9
  2. Primary endpoints revised (2)v8 Show 5 more changesShow less
    • Primary and study completion dates: Sep 7, 2026 to Oct 14, 2026
    • Eligibility criteria expanded, about 22 words
    • Secondary endpoints: 23 to 29
    • Site contacts updated at 22 of 23 sites
    • Study arms: 3 to 4
  3. Primary and study completion dates: Dec 29, 2025 to Sep 7, 2026
    • Study sites: 8 to 23
    v7
  4. Eligibility criteria expanded, about 12 wordsv6
  5. Study sites: 5 to 8v5
  6. Primary completion date: Oct 31, 2024 to Dec 29, 2025v4 Show 6 more changesShow less
    • Enrollment target: 126 to 162
    • Study sites: 3 to 5
    • Study completion date: Feb 26, 2027 to Dec 29, 2025
    • Interventions: Dostarlimab (Drug), GSK4381562 (Drug) to Dostarlimab (Drug), GSK4381562 (Drug), GSK4428859A (Drug)
    • Secondary endpoints: 17 to 23
    • Study arms: 2 to 3
  7. Primary endpoints: 4 to 2
    • Study sites: 1 to 3
    v3
  8. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Primary completion date: Feb 22, 2023 to Oct 31, 2024
    • Study sites: 0 to 1
    • Study completion date: Aug 9, 2023 to Feb 26, 2027
    • Start date changed from estimate of Mar 11, 2022 to Mar 22, 2022
  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.
GlaxoSmithKline
246 trials monitored
See 20 trials at risk
Breast Cancer
5,455 trials monitored
See 306 trials at risk
Lung Cancer
4,798 trials monitored
See 270 trials at risk
Colorectal Cancer
3,405 trials monitored
See 162 trials at risk
and 5 more diseases
This is a first time in-human (FTIH) study designed to investigate the safety, tolerability, pharmacokinetics (PK), and immunogenicity of remzistotug in participants with select loco-regionally recurrent solid tumors or metastatic solid tumors where curative or standard treatment options have been exhausted.
Trial Details
NCT Number NCT05277051
Lead Sponsor GlaxoSmithKline
Conditions
(from sponsor)		 Neoplasms
Related terms Breast Neoplasms, Carcinoma, Non-Small-Cell Lung, Carcinoma, Renal Cell, Colorectal Neoplasms, Endometrial Neoplasms, Neoplasm Metastasis, Neoplasms, Squamous Cell Carcinoma of Head and Neck, Stomach Neoplasms
Enrollment 152 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov