First-Time-in-Human Study of GSK4381562 in Participants With Advanced Solid Tumors (NCT05277051) | Clinical Trial Compass
Active — Not RecruitingPhase 1
First-Time-in-Human Study of GSK4381562 in Participants With Advanced Solid Tumors
United States152 participantsStarted 2022-03-22
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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 Oncol…
What they're measuring
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)