Recent Updates
Recently added Catalysts

GSK6097608

Phase 1

Neoplasms | Small molecule | Oncology |GSK plc|Last Updated: Oct 27, 2025

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

CONTROLLED
Total Trials1
Total Enrollment107

FDA Designations

No designations recorded

Clinical trial landscape

GSK6097608 · 1 trial · 1 indication

Phase 1 1
NCT04446351Study of the Safety and Effectiveness of GSK6097608 in Participants With Advanced Solid TumorsNeoplasms
ACTIVE NOT_RECRUITING107 Analytics
PHASE1ACTIVE NOT_RECRUITING
Study of the Safety and Effectiveness of GSK6097608 in Participants With Advanced Solid Tumors
NeoplasmsUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of participants with dose-limiting toxicities (DLTs)
Up to Day 21
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Up to 2 years

Secondary Endpoints

Number of participants with clinically significant changes in laboratory parameters, vital signs, and 12-lead electrocardiogram (ECG) findings
Up to 2 years
Number of participants with dose reductions or delay
Up to 2 years
Number of participants withdrawn due to AEs
Up to 2 years
Unlock Study Endpoints

Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Participants receiving GSK6097608 monotherapy (Arm A)EXPERIMENTALParticipants will be administered an intravenous (IV) infusion of GSK6097608 every 3 weeks as monotherapy in escalating doses.
Participants receiving GSK6097608 plus dostarlimab (Arm B)EXPERIMENTALParticipants will be administered IV infusion of GSK6097608 every 3 weeks in escalating doses followed by dostarlimab.
Participants receiving dostarlimab monotherapy (Arm D)EXPERIMENTALParticipants 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).
Participants receiving dostarlimab plus belrestotug (Arm E)EXPERIMENTALParticipants will be administered IV infusions of dostarlimab followed by belrestotug, every 3 weeks.
Participants receiving dostarlimab plus belrestotug plus GSK6097608 (Arm F)EXPERIMENTALParticipants will be administered an IV infusion of dostarlimab followed by belrestotug followed by GSK6097608 every 3 weeks.
Participants receiving dostarlimab plus cobolimab (Arm G)EXPERIMENTALParticipants will be administered an IV infusion of cobolimab followed by dostarlimab

Interventions

NameTypeDescription
GSK6097608DRUGGSK6097608 will be administered as an IV infusion.
DostarlimabDRUGDostarlimab will be administered as an IV infusion.
CobolimabDRUGCobolimab will be administered as an IV infusion.
BelrestotugDRUGBelrestotug will be administered as an IV infusion.
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites11

Inclusion Criteria: * 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 * Histological or cytological documentation...

Countries:United StatesCanadaJapanSouth Korea
Unlock Eligibility Criteria

Frequently asked questions about GSK6097608

What is GSK6097608 used for?

GSK6097608 is an investigational small molecule being studied for the treatment of neoplasms, which are abnormal growths of tissue that can be benign or malignant. It is currently in Phase 1 clinical development for advanced solid tumors.

Who is developing GSK6097608?

GSK6097608 is being developed by GSK plc, a global biopharma company listed on the stock exchange under the ticker GSK. The drug is in early-stage clinical development for oncology indications.

What phase is GSK6097608 in?

GSK6097608 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied for safety and effectiveness in patients with advanced solid tumors.

What clinical trials is GSK6097608 in?

GSK6097608 is being studied in a Phase 1 clinical trial with the identifier NCT04446351. This trial is titled "Study of the Safety and Effectiveness of GSK6097608 in Participants With Advanced Solid Tumors" and is active but not recruiting participants.

Is GSK6097608 the same as any other drug?

GSK6097608 is the code name for this investigational drug. No alternative brand names or other designations have been disclosed for this compound in its clinical development.