A First-in-human Study to Learn How Safe the Study Drug BAY3375968, an Anti-CCR8 Antibody, is, When Given Alone or in Combination With Pembrolizumab, How it Affects the Body, How it Moves Into, Through, and Out of the Body, and to Find the Best Dose in Participants With Advanced Solid Tumors
- Trial number:
- NCT05537740
- Trial phase:
- 1
- Study type:
- Immunotherapy, Targeted therapy, Chemotherapy
- Overall status:
- Not yet recruiting
Study start date
Scientific title
Summary
Capable of giving signed informed consent.Has received, been intolerant to, or been ineligible for all treatment options proven to confer clinical benefit. Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Eastern Cooperative Oncology Group (ECOG) Performance status (PS) of 0 or 1. Adequate renal and liver function. Male individuals and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use methods of contraception. Female participants are eligible if they are not pregnant, not breastfeeding or not a Woman of childbearing potential (WOCBP). Inclusion criterion for the dose-escalation: Individuals with histologically or cytologically confirmed, advanced or metastatic solid tumors. Inclusion criteria for disease-specific combination expansion: Individuals with histologically or cytologically confirmed Triple-negative breast cancer (TNBC), Non-small cell lung cancer (NSCLC), Head and neck squamous cell carcinoma (HNSCC), or melanoma. Inclusion criterion for the monotherapy-MoA expansion: Individuals with histologically or cytologically confirmed NSCLC. Willingness and medical feasibility (as per Investigator assessment) to undergo paired tumor biopsies with a non-significant risk.