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Remzistotug

Phase 1

Neoplasms | Small molecule | Oncology |GSK plc|Last Updated: Jun 25, 2026

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment152

FDA Designations

No designations recorded

Clinical trial landscape

Remzistotug · 1 trial · 1 indication

Phase 1 1
NCT05277051First-Time-in-Human Study of GSK4381562 in Participants With Advanced Solid TumorsNeoplasms
ACTIVE NOT_RECRUITING152 Analytics
PHASE1ACTIVE NOT_RECRUITING
First-Time-in-Human Study of GSK4381562 in Participants With Advanced Solid Tumors
NeoplasmsUnlock trial analytics

Study Endpoints

Primary Endpoints

Arms A, B, C, I: Number of Participants with dose-limiting toxicities (DLTs)
Up to 21 days
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Up to 27 months

Secondary Endpoints

Number of Participants With Clinically Significant Changes in Laboratory Parameters, Electrocardiogram (ECG) and Vital Signs
Up to 24 months
Number of Participants With Dose Reductions or Delays
Up to 24 months
Number of Participants With Withdrawals due to AEs
Up to 27 months
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Participants Receiving remzistotug Monotherapy (Arm A)EXPERIMENTAL -
Participants Receiving remzistotug Plus Dostarlimab (Arm B)EXPERIMENTAL -
Participants Receiving remzistotug Plus Dostarlimab Plus belrestotug (Arm C)EXPERIMENTAL -
Participants Receiving Dostarlimab Plus belrestotug (Arm D)EXPERIMENTAL -
Participants Receiving dostarlimab Plus belrestotug Plus remzistotug (Arm E)EXPERIMENTAL -
Participants Receiving dostarlimab Plus belrestotug Plus nelistotug (Arm F)EXPERIMENTAL -
China Cohort: Participants receiving dostarlimab (Arm G)EXPERIMENTAL -
Participants Receiving GSK5764227 Plus dostarlimab (Arm I)EXPERIMENTAL -

Interventions

NameTypeDescription
RemzistotugDRUGRemzistotug will be administered.
DostarlimabDRUGDostarlimab will be administered.
BelrestotugDRUGBelrestotug will be administered.
NelistotugDRUGNelistotug will be administered.
GSK5764227DRUGGSK5764227 will be administered.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites26

Inclusion criteria: * A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least 1 of the following conditions applies: * Is not a woman of childbearing potential (WOCBP) or * Is a WOCBP and using a contraceptive method that is highly effective with a...

Countries:United StatesAustraliaCanadaChinaFranceJapanSouth KoreaSpainUnited Kingdom
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Recent Changes (Last 90 Days)

LOWJun 25, 2026NCT05277051lastUpdatePostDate: changed
LOWJun 25, 2026NCT05277051lastUpdatePostDate: changed
LOWJun 25, 2026NCT05277051lastUpdatePostDate: changed

Frequently asked questions about Remzistotug

What is Remzistotug used for?

Remzistotug is an investigational small molecule being developed 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.

What does Remzistotug target?

Remzistotug is a small molecule, but its specific molecular target has not been disclosed. It is being studied in oncology for the treatment of advanced solid tumors, though the exact biological pathway it affects is not publicly detailed.

Who makes Remzistotug?

Remzistotug is being developed by GSK plc, a global biopharma company listed on the London Stock Exchange under the ticker GSK. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with advanced solid tumors.

What phase is Remzistotug in?

Remzistotug is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to assess its safety, tolerability, and potential efficacy in treating neoplasms.

What clinical trials is Remzistotug in?

Remzistotug is being evaluated in a first-time-in-human study (NCT05277051) in participants with advanced solid tumors. This Phase 1 trial is active but not recruiting, with an enrollment of 152 participants across multiple countries including the United States, Australia, Canada, China, France, Japan, South Korea, Spain, and the United Kingdom.

Is Remzistotug the same as GSK4381562?

Yes, Remzistotug is also known as GSK4381562. The clinical trial NCT05277051, which is studying this drug, uses the name GSK4381562 in its title. Both names refer to the same investigational small molecule being developed by GSK plc.