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
Active, not recruiting
Active, not recruiting
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Number of participants withdrawn due to AEs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
Observational study model:
Not applicable
Primary completion date:
2026-31-12
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
Location
GSK Investigational Site
Tokyo, Japan, 104-0045
Status
Recruitment Complete
Location
GSK Investigational Site
Chiba, Japan, 277-8577
Status
Study Complete
Location
GSK Investigational Site
Boston, MA, United States, 02215
Status
Study Complete
Location
GSK Investigational Site
Ottawa, ON, Canada, K1H 8L6
Status
Study Complete
Location
GSK Investigational Site
Toronto, ON, Canada, M5G 1Z5
Status
Study Complete

Study documents

No study documents available.

Results overview

Study Results yet to be posted

Recruitment status
Active, not recruiting
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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