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

Inclusion Criteria19

• 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.