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RECRUITINGPHASE1

First-Time-in-Human Study of GSK4381562 in Participants With Advanced Solid Tumors

A Phase 1 First-Time-in-Human, Open-Label Study of GSK4381562 Administered as Monotherapy and in Combination With Anticancer Agents in Participants With Selected Advanced Solid Tumors

NCT05277051•GlaxoSmithKline

View on ClinicalTrials.gov

Summary

This is a first time in-human (FTIH) study designed to investigate the safety, tolerability, pharmacokinetics (PK), and immunogenicity of remzistotug in participants with select loco-regionally recurrent solid tumors or metastatic solid tumors where curative or standard treatment options have been exhausted.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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 failure rate of less than (\<)1 percent (\[%\] per year), during the intervention period and for specified time after end of study treatment.
•* A WOCBP must have a negative highly sensitive pregnancy test within 24-48 hours before the first dose of study intervention.
•* Requirement for Arm I only: Male participants agree to use contraception and for their female partner to use contraception, if applicable.
•Histological or cytological documentation of loco-regionally recurrent solid tumors where curative treatment options have been exhausted, or metastatic solid tumors; types as follows:
•* head and neck squamous cell carcinoma (HNSCC)
•* non-small-cell lung cancer (NSCLC)
•* breast cancer (BC)
•* clear cell renal cell cancer (ccRCC)
+9 more criteria

Exclusion Criteria

•Prior treatment with the following therapies (specified time periods are from last dose of prior treatment to first dose of study intervention):
•* Any therapy directed against Polio virus receptor (PVR)-related immunoglobulin domain-containing (PVRIG) (COM701 or other anti-PVRIG monoclonal antibody \[mAb\]) or other cluster of differentiation (CD)226 axis receptor (T-cell immunoglobulin and immunoreceptor tyrosine-based inhibition motif domain \[TIGIT\] or CD96) at any time.
•* For Arm I only, prior treatment with orlotamab, enoblituzumab, I-Dxd, or other B7-H3 targeted agents.
•* Other prior immunotherapy, chemotherapy, targeted therapy, biological therapy or radiation therapy within specified periods as defined in the protocol.
•* Investigational therapy: if the participant has participated in a clinical study and has received an investigational product within 4 weeks or 5 half-lives of the investigational product (whichever is shorter).
•Prior allogenic or autologous bone marrow transplantation or other solid organ transplantation.
•Toxicity from previous anticancer treatment, including:
•* Greater than or equal to Grade 3 immune-mediated toxicity considered related to prior immunotherapy and that led to treatment discontinuation; or
•* History of myocarditis of any grade during a previous treatment with immunotherapy
•* Toxicity related to prior treatment that has not resolved to less than or equal to (\<=) Grade 1. Non clinically relevant Grade 2 toxicities, not constituting a safety risk by investigator judgment are allowed.
+1 more criteria

Locations (26)

GSK Investigational Site

San Francisco, California, United States

GSK Investigational Site

Charlotte, North Carolina, United States

GSK Investigational Site

Oklahoma City, Oklahoma, United States

GSK Investigational Site

Philadelphia, Pennsylvania, United States

GSK Investigational Site

Dallas, Texas, United States

GSK Investigational Site

San Antonio, Texas, United States

GSK Investigational Site

Salt Lake City, Utah, United States

GSK Investigational Site

Nedlands, Western Australia, Australia

GSK Investigational Site

Ottawa, Ontario, Canada

GSK Investigational Site

Toronto, Ontario, Canada

Key Dates

Start Date

March 22, 2022

Primary Completion Date

August 31, 2027

Completion Date

August 31, 2027

Last Updated

December 19, 2025

Enrollment

158

ESTIMATED participants

Conditions

Neoplasms

Interventions

Remzistotug

DRUG

Dostarlimab

DRUG

Belrestotug

DRUG

Nelistotug

DRUG

GSK5764227

DRUG

Contacts

US GSK Clinical Trials Call Center

CONTACT

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

CONTACT

+44 (0) 20 89904466 GSKClinicalSupportHD@gsk.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 19, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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First-Time-in-Human Study of GSK4381562 in Participants With Advanced Solid Tumors

Inclusion Criteria

Exclusion Criteria

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