Last updated: 10/24/2025 12:50:12

Study of the Safety and Effectiveness of GSK6097608 in Participants with Advanced Solid Tumors

GSK study ID
212214
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Recruitment complete
Recruitment complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A Phase 1 First-Time-in-Human, Open-Label Study of GSK6097608 Administered as Monotherapy and in Combination with Anticancer Agents in Participants with Advanced Solid Tumors
Trial description: This first-time-in-human (FTIH) study will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary clinical activity of escalating doses of GSK6097608 given as monotherapy and in combination with dostarlimab in participants with advanced solid tumors. In addition, dostarlimab will be given as monotherapy (Arm D); and in combination with belrestotug (Arm E); and with GSK6097608 + belrestotug (Arm F) in Japanese and Chinese participants. The study may assess the PK/PD cohorts for Arm E and/or Arm F in participants outside of China and Japan. Additionally, dostarlimab will be given in combination with cobolimab in Japanese participants. Drug name mentioned as belrestotug, GSK4428859A and EOS884448 are interchangeable for the same compound. In the rest of the document, the drug will be referred to as belrestotug.
Primary purpose:
Treatment
Trial design:
Sequential
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:

Number of participants with dose-limiting toxicities (DLTs)

Timeframe: Up to Day 21

Number of participants with adverse events (AEs) and serious adverse events (SAEs)

Timeframe: Up to 2 years

Secondary outcomes:

Number of participants with clinically significant changes in laboratory parameters, vital signs, and 12-lead electrocardiogram (ECG) findings

Timeframe: Up to 2 years

Number of participants with dose reductions or delay

Timeframe: Up to 2 years

Number of participants withdrawn due to AEs

Timeframe: Up to 2 years

Overall response rate (ORR) based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

Timeframe: Up to 2 years

Arms D, E, F, G: ORR based on modified Response Evaluation Criteria in Solid Tumors (iRECIST)

Timeframe: Up to 2 years

Arms D, E, F, G: Disease Control Rate (DCR) based on RECIST 1.1

Timeframe: Up to 2 years

Arms D, E, F, G: DCR based on iRECIST

Timeframe: Up to 2 years

Arms D, E, F, G: Time to response (TTR) based on RECIST 1.1

Timeframe: Up to 2 years

Arms D, E, F, G: TTR based on iRECIST

Timeframe: Up to 2 years

Arms D, E, F, G: Duration of response (DOR) based on RECIST 1.1

Timeframe: Up to 2 years

Arms D, E, F, G: DOR based on iRECIST

Timeframe: Up to 2 years

Arms D, E, F, G: Progression-free survival (PFS) based on RECIST 1.1

Timeframe: Up to 2 years

Arms D, E, F, G: PFS based on iRECIST

Timeframe: Up to 2 years

Arms A, B, F: Number of participants with positive anti-drug antibodies (ADAs) against GSK6097608

Timeframe: Up to 2 years

Arms A, B, F: Titers of ADAs against GSK6097608

Timeframe: Up to 2 years

Arms B, D, E, F, G: Number of participants with positive ADAs against dostarlimab

Timeframe: Up to 2 years

Arms B, D, E, F, G: Titers of ADAs against dostarlimab

Timeframe: Up to 2 years

Arms E, F: Number of participants with positive ADAs against belrestotug

Timeframe: Up to 2 years

Arms E, F: Titers of ADAs against belrestotug

Timeframe: Up to 2 years

Arm G: Number of participants with positive ADAs against cobolimab

Timeframe: Up to 2 years

Arm G: Titers of ADAs against cobolimab

Timeframe: Up to 2 years

Arms A, B, F: Maximum observed concentration (Cmax) for GSK6097608

Timeframe: Up to 2 years

Arms A, B, F: Minimum observed concentration (Cmin) for GSK6097608

Timeframe: Up to 2 years

Arms A, B, F: Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC[0-infinity]) for GSK6097608

Timeframe: Up to 2 years

Arms A, B, F: Area under the plasma concentration-time curve from time zero to time (AUC[0-t]) for GSK6097608

Timeframe: Up to 2 years

Arms A, B, F: Apparent terminal phase half-life (t1/2) for GSK6097608

Timeframe: Up to 2 years

Arms B, D, E, F, G: Cmax for dostarlimab

Timeframe: Up to 2 years

Arms B, D, E, F, G: Cmin for dostarlimab

Timeframe: Up to 2 years

Arms B, D, E, F, G: AUC(0-infinity) for dostarlimab

Timeframe: Up to 2 years

Arms B, D, E, F, G: AUC(0-t) for dostarlimab

Timeframe: Up to 2 years

Arms B, D, E, F, G: t1/2 for dostarlimab

Timeframe: Up to 2 years

Arms E, F: Cmax for belrestotug

Timeframe: Up to 2 years

Arms E, F: Cmin for belrestotug

Timeframe: Up to 2 years

Arms E, F: AUC(0-infinity) for belrestotug

Timeframe: Up to 2 years

Arms E, F: AUC(0-t) for belrestotug

Timeframe: Up to 2 years

Arms E, F: t1/2 for belrestotug

Timeframe: Up to 2 years

Arm G: Cmax for cobolimab

Timeframe: Up to 2 years

Arm G: Cmin for cobolimab

Timeframe: Up to 2 years

Arm G: AUC(0-infinity) for cobolimab

Timeframe: Up to 2 years

Arm G: AUC(0-t) for cobolimab

Timeframe: Up to 2 years

Arm G: t1/2 for cobolimab

Timeframe: Up to 2 years

Interventions:
  • Drug: GSK6097608
  • Drug: Dostarlimab
  • Drug: Cobolimab
  • Drug: Belrestotug
  • Enrollment:
    107
    Primary completion date:
    2026-31-12
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Neoplasms
    Product
    Not applicable
    Collaborators
    23andMe, iTeos Therapeutics
    Study date(s)
    June 2020 to December 2026
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    No
    • Adults 18 years of age or older (or >=20 years of age in Arm-A Japan, Arm-D Japan, Arm E-Japan, Arm F-Japan, and Arm G-Japan)
    • Female participants of childbearing potential must agree to use a highly effective form of contraception
    • Prior anti-cancer treatment including investigational agents, immune checkpoint inhibitors, chemotherapy, targeted therapy, and biological therapy: within 4 weeks or 5 half-lives of the drug, whichever is shorter
    • Prior allogenic or autologous bone marrow transplantation or other solid organ transplantation

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    San Antonio, TX, United States, 78229
    Status
    Study Complete
    Location
    GSK Investigational Site
    Dallas, TX, United States, 75230
    Status
    Study Complete
    Location
    GSK Investigational Site
    Houston, TX, United States, 77030-4009
    Status
    Study Complete
    Location
    GSK Investigational Site
    Los Angeles, CA, United States, 90025
    Status
    Study Complete
    Location
    GSK Investigational Site
    SEOUL, South Korea, 03080
    Status
    Study Complete
    Location
    GSK Investigational Site
    Seoul, South Korea, 06351
    Status
    Study Complete
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    Study documents

    No study documents available.

    Results overview

    Study Results yet to be posted

    Recruitment status
    Recruitment complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    Not applicable

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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