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

Running, not enrolling · Phase 1

Conditions studied: Neoplasms

In brief

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.

Key facts

Study ID

NCT05277051

Run by

GlaxoSmithKline

People needed

152

Starts

2022-03-22

Expected to finish

2027-08-31

Last updated by the study team

2026-06-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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