First-Time-in-Human Study of GSK4381562 in Participants With Advanced Solid Tumors
NCT ID: NCT05277051
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
158 participants
INTERVENTIONAL
2022-03-22
2027-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Participants receiving GSK4381562 monotherapy (Arm A)
GSK4381562
GSK4381562 will be administered.
Participants receiving GSK4381562 plus dostarlimab (Arm B)
GSK4381562
GSK4381562 will be administered.
Dostarlimab
Dostarlimab will be administered.
Participants receiving GSK4381562 plus dostarlimab plus belrestotug (Arm C)
GSK4381562
GSK4381562 will be administered.
Dostarlimab
Dostarlimab will be administered.
Belrestotug
Belrestotug will be administered.
Participants receiving dostarlimab plus belrestotug (Arm D)
Dostarlimab
Dostarlimab will be administered.
Belrestotug
Belrestotug will be administered.
Participants receiving dostarlimab plus belrestotug plus GSK4381562 (Arm E)
GSK4381562
GSK4381562 will be administered.
Dostarlimab
Dostarlimab will be administered.
Belrestotug
Belrestotug will be administered.
Participants receiving dostarlimab plus belrestotug plus nelistotug (Arm F)
Dostarlimab
Dostarlimab will be administered.
Belrestotug
Belrestotug will be administered.
Nelistotug
Nelistotug will be administered.
China Cohort: Participants receiving dostarlimab (Arm G)
Dostarlimab
Dostarlimab will be administered.
China Cohort: Participants receiving dostarlimab plus belrestotug (Arm H)
Dostarlimab
Dostarlimab will be administered.
Belrestotug
Belrestotug will be administered.
Participants receiving GSK5764227 plus dostarlimab (Arm I)
Dostarlimab
Dostarlimab will be administered.
GSK5764227
GSK5764227 will be administered.
Interventions
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GSK4381562
GSK4381562 will be administered.
Dostarlimab
Dostarlimab will be administered.
Belrestotug
Belrestotug will be administered.
Nelistotug
Nelistotug will be administered.
GSK5764227
GSK5764227 will be administered.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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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
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
Countries
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Central Contacts
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EU GSK Clinical Trials Call Center
Role: CONTACT
Phone: +44 (0) 20 89904466
Email: [email protected]
Facility Contacts
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US GSK Clinical Trials Call Center
Role: primary
EU GSK Clinical Trials Call Centre
Role: backup
US GSK Clinical Trials Call Center
Role: primary
EU GSK Clinical Trials Call Centre
Role: backup
US GSK Clinical Trials Call Center
Role: primary
EU GSK Clinical Trials Call Centre
Role: backup
US GSK Clinical Trials Call Center
Role: primary
EU GSK Clinical Trials Call Centre
Role: backup
US GSK Clinical Trials Call Center
Role: primary
EU GSK Clinical Trials Call Centre
Role: backup
US GSK Clinical Trials Call Center
Role: primary
EU GSK Clinical Trials Call Centre
Role: backup
US GSK Clinical Trials Call Center
Role: primary
EU GSK Clinical Trials Call Centre
Role: backup
US GSK Clinical Trials Call Center
Role: primary
EU GSK Clinical Trials Call Centre
Role: backup
US GSK Clinical Trials Call Center
Role: primary
EU GSK Clinical Trials Call Centre
Role: backup
US GSK Clinical Trials Call Center
Role: primary
EU GSK Clinical Trials Call Centre
Role: backup
US GSK Clinical Trials Call Center
Role: primary
EU GSK Clinical Trials Call Centre
Role: backup
US GSK Clinical Trials Call Center
Role: primary
EU GSK Clinical Trials Call Centre
Role: backup
US GSK Clinical Trials Call Center
Role: primary
EU GSK Clinical Trials Call Centre
Role: backup
US GSK Clinical Trials Call Center
Role: primary
EU GSK Clinical Trials Call Centre
Role: backup
US GSK Clinical Trials Call Center
Role: primary
EU GSK Clinical Trials Call Centre
Role: backup
US GSK Clinical Trials Call Center
Role: primary
EU GSK Clinical Trials Call Centre
Role: backup
US GSK Clinical Trials Call Center
Role: primary
EU GSK Clinical Trials Call Centre
Role: backup
US GSK Clinical Trials Call Center
Role: primary
EU GSK Clinical Trials Call Centre
Role: backup
Other Identifiers
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2023-509414-11
Identifier Type: OTHER
Identifier Source: secondary_id
217228
Identifier Type: -
Identifier Source: org_study_id