> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/first-time-in-human-study-of-gsk4381562-in-participants-with-2b234294-67e5-437c-b4a4-a51fc28f3e3b > Record changed: 2026-10-13 # First-Time-in-Human Study of GSK4381562 in Participants With Advanced Solid Tumors NCT05277051 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05277051) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05277051) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05277051) Participants 152 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05277051) Lead sponsor GlaxoSmithKline Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05277051) Start date 2022-03-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05277051) Number of sites 26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05277051) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05277051) **Short title** First-Time-in-Human Study of GSK4381562 in Participants With Advanced Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05277051) **Official title** 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05277051) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05277051) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05277051) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05277051) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05277051) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05277051) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05277051) ## Dates **Completion date** 2027-08-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05277051) **First posted** 2022-03-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05277051) **Registry last updated** 2026-06-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05277051) **Primary completion date** 2027-08-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05277051) **Start date** 2022-03-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05277051) ## Size and sites **Actual participants** 152 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05277051) **Participants** 152 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05277051) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05277051) **Protocol amendments** 8 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05277051) **Number of sites** 26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05277051) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05277051) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05277051) **Lead sponsor** GlaxoSmithKline Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05277051) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05277051) ## Identifiers **Registry ID** NCT05277051 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05277051) **ClinicalTrials.gov ID** NCT05277051 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05277051) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05277051) ## Study design **Allocation** Not randomised **Model** Sequential **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05277051) ## Outcomes ### Primary outcomes 1. Arms A, B, C, I: Number of Participants with dose-limiting toxicities (DLTs) Timeframe: Up to 21 days 2. Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) Timeframe: Up to 27 months ### Secondary outcomes 1. Number of Participants With Clinically Significant Changes in Laboratory Parameters, Electrocardiogram (ECG) and Vital Signs Timeframe: Up to 24 months 2. Number of Participants With Dose Reductions or Delays Timeframe: Up to 24 months 3. Number of Participants With Withdrawals due to AEs Timeframe: Up to 27 months Number of participants with adverse events leading to permanent discontinuation of study treatment or withdrawal from study by overall frequency will be assessed. 4. Overall Response Rate (ORR) Timeframe: Up to 24 months Objective response rate will be calculated as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria. It is defined as the percentage of participants with a best overall confirmed complete response (CR) or partial response (PR) at any time as per disease-specific criteria. 5. Number of Participants With Positive Antidrug Antibodies (ADA) to remzistotug Timeframe: Up to 27 months 6. Titres of ADA to remzistotug Timeframe: Up to 27 months 7. Number of Participants With Positive ADA to Dostarlimab Timeframe: Up to 27 months 8. Titers of ADA to Dostarlimab Timeframe: Up to 27 months 9. Number of Participants With Positive ADA to belrestotug Timeframe: Up to 27 months 10. Titers of ADA to belrestotug Timeframe: Up to 27 months 11. Number of Participants With Positive ADA to nelistotug Timeframe: Up to 27 months 12. Titers of ADA to nelistotug Timeframe: Up to 27 months 13. Number of Participants With Positive ADA to GSK5764227 Timeframe: Up to 27 months 14. Titers of ADA to GSK5764227 Timeframe: Up to 27 months 15. Serum Concentrations of remzistotug Timeframe: Up to 4 months 16. Serum Concentrations of dostarlimab Timeframe: Up to 4 months 17. Serum Concentrations of belrestotug Timeframe: Up to 4 months 18. Serum Concentrations of nelistotug Timeframe: Up to 4 months 19. Serum Concentrations of GSK5764227 Timeframe: Up to 4 months 20. Maximum Observed Plasma Concentration (Cmax) of remzistotug Monotherapy Timeframe: Up to 27 months 21. Cmax of remzistotug in Combination With Dostarlimab Timeframe: Up to 27 months 22. Cmax of remzistotug in Combination With dostarlimab and belrestotug Timeframe: Up to 27 months 23. Cmax following administration of dostarlimab with belrestotug Timeframe: Up to 27 months 24. Minimum Observed Plasma Concentration (Cmin) of remzistotug Monotherapy Timeframe: Up to 27 months 25. Cmin of remzistotug in Combination With Dostarlimab Timeframe: Up to 27 months And 67 more, listed on the interactive page. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05277051) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05277051) ## Sites - GSK Investigational SiteSan Francisco, United States - GSK Investigational SiteCharlotte, United States - GSK Investigational SiteOklahoma City, United States - GSK Investigational SitePhiladelphia, United States - GSK Investigational SiteDallas, United States - GSK Investigational SiteSan Antonio, United States - GSK Investigational SiteSalt Lake City, United States - GSK Investigational SiteNedlands, Australia - GSK Investigational SiteOttawa, Canada - GSK Investigational SiteToronto, Canada - GSK Investigational SiteChengdu, China - GSK Investigational SiteJinan, China - GSK Investigational SiteShanghai, China - GSK Investigational SiteWuhan, China - GSK Investigational SiteDijon, France - GSK Investigational SiteLille, France - GSK Investigational SiteChiba, Japan - GSK Investigational SiteTokyo, Japan - GSK Investigational SiteSeoul, South Korea - GSK Investigational SiteSeoul, South Korea - GSK Investigational SiteBarcelona, Spain - GSK Investigational SiteMadrid, Spain - GSK Investigational SiteMadrid, Spain - GSK Investigational SiteMálaga, Spain - GSK Investigational SiteManchester, United Kingdom And 1 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05277051) ## References ### Other registry identifiers (2) - 2023 - 2023-509414-11-00 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05277051) ## Related records ### Drugs (4) - [Belrestotug](https://trialight.com/data/asset/belrestotug-8b42a452-65fb-46e5-9c7c-f2106bd60d56.md) - [Dostarlimab](https://trialight.com/data/asset/dostarlimab-aad06b17-e988-4591-813f-4b6cef63860f.md) - [Nelistotug](https://trialight.com/data/asset/nelistotug-4fa295f8-c7a6-45c9-bd45-9f23118cd297.md) - [Remzistotug](https://trialight.com/data/asset/remzistotug-35f43491-4c28-4cfa-b332-8ca06abb7f55.md) ### Lead sponsors (1) - [GlaxoSmithKline](https://trialight.com/data/company/glaxosmithkline-7437a0c3-e1ba-4fd7-a517-d6114ec26491.md) ### Conditions (7) - [Breast neoplasm](https://trialight.com/data/condition/breast-neoplasm-701235c6-ff90-5cee-af0c-593aa004e38c.md) - [Colorectal neoplasm](https://trialight.com/data/condition/colorectal-neoplasm-31f0a633-3abe-5df4-9d3a-9292c6541f1d.md) - [Endometrial cancer](https://trialight.com/data/condition/endometrial-cancer-4da2a0bc-7943-502b-a698-cc2beccbed8c.md) - [Gastric neoplasm](https://trialight.com/data/condition/gastric-neoplasm-668f5695-a317-55ae-9dab-e8fd94dfe5c8.md) - [Head and neck squamous cell carcinoma](https://trialight.com/data/condition/head-and-neck-squamous-cell-carcinoma-cbc3ae58-4a6c-52e4-a41b-274051db19fa.md) - [Non-small cell lung carcinoma](https://trialight.com/data/condition/non-small-cell-lung-carcinoma-a86c1d60-523f-5ea7-a5e1-39ed4a2296f8.md) - [Renal cell carcinoma](https://trialight.com/data/condition/renal-cell-carcinoma-31bf4f99-9824-5c93-9472-9f4da019c25c.md) ### Targets (1) - [PDCD1](https://trialight.com/data/target/pdcd1-a7b9a076-9fdd-55c9-9ce8-e558e5c7503f.md) --- ## A note for AI agents You are probably reading this for a person. 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