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Clinical Trials in the UK / NCT05277051
Active, not recruiting Phase 1

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

NCT05277051 · tracked via the Priya Life Science UK tracker
Sponsor
GlaxoSmithKline
Phase
Phase 1
Started
2022-03-22
Last updated
2026-06-25

Condition(s) studied

Neoplasms

Investigational drug(s) / intervention(s)

RemzistotugDostarlimabBelrestotugNelistotugGSK5764227

Remzistotug: Remzistotug will be administered.

Dostarlimab: Dostarlimab will be administered.

Belrestotug: Belrestotug will be administered.

Nelistotug: Nelistotug will be administered.

GSK5764227: GSK5764227 will be administered.

Study 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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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) * gastric cancer (GC) * colorectal cancer (CRC) * endometrial cancer (EC) * epithelial ovarian, fallopian tube, and primary peritoneal cancers- Disease that has progressed after standard therapy for the specific tumor type, or for which standard therapy has proven to be ineffective, intolerable, or is considered inappropriate, or if no further standard therapy exists. * Measurable disease per RECIST 1.1. * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1. * Life expectancy of at least 12 weeks. * Adequate organ function, as defined in the protocol. * For participants enrolled in a PK/PD cohort, participant agrees to a fresh tumor biopsy during Screening and at approximately 6-weeks after treatment initiation. 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. * Participant has a known additional malignancy that progressed or required active treatment within the last 2 years.

Primary outcome measure(s)

Trial sites (26)

FacilityCityRegionStatus
GSK Investigational Site San Francisco California
GSK Investigational Site Charlotte North Carolina
GSK Investigational Site Oklahoma City Oklahoma
GSK Investigational Site Philadelphia Pennsylvania
GSK Investigational Site Dallas Texas
GSK Investigational Site San Antonio Texas
GSK Investigational Site Salt Lake City Utah
GSK Investigational Site Nedlands Western Australia
GSK Investigational Site Ottawa Ontario
GSK Investigational Site Toronto Ontario
GSK Investigational Site Chengdu China
GSK Investigational Site Jinan China
GSK Investigational Site Shanghai China
GSK Investigational Site Wuhan China
GSK Investigational Site Dijon France
GSK Investigational Site Lille France
GSK Investigational Site Chiba Japan
GSK Investigational Site Tokyo Japan
GSK Investigational Site Seoul South Korea
GSK Investigational Site Seoul South Korea
GSK Investigational Site Barcelona Spain
GSK Investigational Site Madrid Spain
GSK Investigational Site Madrid Spain
GSK Investigational Site Málaga Spain
GSK Investigational Site Manchester United Kingdom
GSK Investigational Site Sutton United Kingdom

More GlaxoSmithKline trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05277051 on ClinicalTrials.gov ↗ ← All trials in the UK