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GSK6097608 + Dostarlimab for Advanced Cancers

Phase 1
Recruiting
Research Sponsored by GlaxoSmithKline
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern cooperative oncology group (ECOG) performance status (PS) 0 to 1
Female participants of childbearing potential must agree to use a highly effective form of contraception
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Study Summary

This trial will test the safety and effectiveness of a new drug, GSK6097608, given alone or with another new drug, dostarlimab, to people with advanced solid tumors. The trial will also test dostarlimab given alone or with GSK6097608 and with another new drug, GSK4428859A (EOS884448), to people with advanced solid tumors in Japan and China.

Who is the study for?
Adults with advanced solid tumors who've tried standard treatments without success or can't tolerate them. They must be in good physical condition, have proper organ function, and for certain arms of the trial, provide fresh tumor biopsies. Women able to have children must use effective birth control. Exclusions include uncontrolled brain metastases, recent cancers besides the one being treated, active autoimmune diseases requiring treatment within 2 years, liver disease, infections like HIV/HBV/HCV, heart risks including QT prolongation on ECG.Check my eligibility
What is being tested?
The study tests GSK6097608 alone and combined with dostarlimab against various solid tumors. Dostarlimab is also tested alone and with belrestotug or cobolimab in specific participant groups from Japan and China. The goal is to assess safety and effectiveness while monitoring how the body processes these drugs (pharmacokinetics) and their impact on the body (pharmacodynamics).See study design
What are the potential side effects?
Potential side effects may include reactions at injection sites; symptoms related to immune system activation such as inflammation in different organs; fatigue; changes in blood counts affecting immunity or clotting; digestive issues like nausea or diarrhea; potential risk of infection due to immune modulation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or restricted in physically strenuous activity but can do light work.
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I agree to use effective birth control if I can have children.
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My cancer is advanced, has come back, or has spread to other parts.
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My organ functions are within normal ranges according to recent tests.
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I am at least 18 years old, or 20 if participating in certain Japan arms.
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My cancer has worsened after standard treatment or standard treatment was not suitable for me.
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I can provide a fresh sample of my tumor for the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Number of participants with dose-limiting toxicities (DLTs)
Secondary outcome measures
Arm G: AUC(0-infinity) for cobolimab
Arm G: AUC(0-t) for cobolimab
Arm G: Cmax for cobolimab
+38 more

Trial Design

6Treatment groups
Experimental Treatment
Group I: Participants receiving dostarlimab plus cobolimab (Arm G)Experimental Treatment2 Interventions
Participants will be administered an IV infusion of cobolimab followed by dostarlimab
Group II: Participants receiving dostarlimab plus belrestotug plus GSK6097608 (Arm F)Experimental Treatment3 Interventions
Participants will be administered an IV infusion of dostarlimab followed by belrestotug followed by GSK6097608 every 3 weeks.
Group III: Participants receiving dostarlimab plus belrestotug (Arm E)Experimental Treatment2 Interventions
Participants will be administered IV infusions of dostarlimab followed by belrestotug, every 3 weeks.
Group IV: Participants receiving dostarlimab monotherapy (Arm D)Experimental Treatment1 Intervention
Participants will be administered an IV infusion of dostarlimab monotherapy (1 cohort will receive dostarlimab every 3 weeks and 1 cohort will receive dostarlimab every 6 weeks).
Group V: Participants receiving GSK6097608 plus dostarlimab (Arm B)Experimental Treatment2 Interventions
Participants will be administered IV infusion of GSK6097608 every 3 weeks in escalating doses followed by dostarlimab.
Group VI: Participants receiving GSK6097608 monotherapy (Arm A)Experimental Treatment1 Intervention
Participants will be administered an intravenous (IV) infusion of GSK6097608 every 3 weeks as monotherapy in escalating doses.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cobolimab
2016
Completed Phase 1
~830
Dostarlimab
2020
Completed Phase 2
~1000

Find a Location

Who is running the clinical trial?

iTeos TherapeuticsIndustry Sponsor
7 Previous Clinical Trials
1,299 Total Patients Enrolled
GlaxoSmithKlineLead Sponsor
4,748 Previous Clinical Trials
8,067,268 Total Patients Enrolled
5 Trials studying Tumors
1,919 Patients Enrolled for Tumors
23andMe, Inc.Industry Sponsor
9 Previous Clinical Trials
83,687 Total Patients Enrolled

Media Library

Cobolimab (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04446351 — Phase 1
Tumors Research Study Groups: Participants receiving dostarlimab plus belrestotug (Arm E), Participants receiving dostarlimab plus cobolimab (Arm G), Participants receiving dostarlimab plus belrestotug plus GSK6097608 (Arm F), Participants receiving dostarlimab monotherapy (Arm D), Participants receiving GSK6097608 monotherapy (Arm A), Participants receiving GSK6097608 plus dostarlimab (Arm B)
Tumors Clinical Trial 2023: Cobolimab Highlights & Side Effects. Trial Name: NCT04446351 — Phase 1
Cobolimab (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04446351 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the clinical history of GSK6097608?

"GSK6097608 was first researched at City of Hope a decade ago. So far, 1 study has been completed while 41 studies are ongoing. Many of these active trials taking place in Boston, Massachusetts."

Answered by AI

Are there different test locations for this North American clinical trial?

"To make participation more convenient for patients, this study is being conducted at 7 locations. These sites are situated in Boston, Ottawa, Toronto, and other cities."

Answered by AI

Could you please detail GSK6097608's safety profile?

"GSK6097608 is still in early testing, so there is limited data supporting its safety and efficacy. We've given it a score of 1."

Answered by AI

How many people are testing this medication?

"That is accurate. The information available on clinicaltrials.gov indicates that this trial is actively seeking participants. This trial was posted on June 25th, 2020 and was last updated on August 26th, 2020. The goal is to recruit 178 patients from 7 different sites."

Answered by AI
~67 spots leftby Sep 2025