XTX101 Monotherapy and XTX101 and Pembrolizumab Combination Therapy in Patients With Advanced Solid Tumors

Inclusion Criteria:

Disease Criteria - Part 1A and 1C- Any histologically or cytologically confirmed solid tumor malignancy that is locally advanced or metastatic and has failed standard therapy, or standard therapy is not curative or available; Part 1B - Any histologically or cytologically confirmed solid tumor malignancy for which anti-PD-1 or anti-PD-L1 treatment is approved and has progressed on or after prior anti-PD-1 or anti-PD-L1 therapy. Part 2- histologically or cytologically confirmed unresectable or metastatic melanoma that has not been treated with prior anti-PD-1 or anti-PD-L1 therapy
ECOG performance status of 0 or 1
Adequate organ function
Part 2 only: measurable disease per iRECIST

Exclusion Criteria:

Received prior treatment with anti-CTL-4 therapy
Received prior immune-checkpoint therapy and experienced Grade 3 or greater toxicity lasting greater than 6 weeks
Received prior systemic anticancer therapy within 4 weeks prior to study treatment
Received prior radiotherapy within 2 weeks prior to study treatment
Has a diagnosis of immunodeficiency
Has known malignancy (other than disease under study) that is progressing or has required active treatment within the past 3 years
Has an active autoimmune disease that has required systemic treatment in past 2 years, including the use of disease modifying agents, corticosteroids or immunosuppressive drugs
Has an active infection requiring systemic therapy within 4 weeks prior to study treatment
Has a history of severe hypersensitivity reaction (≥ Grade 3) to any study intervention and/or any of its excipients
Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study
Part 2 only: has ocular melanoma
Part 2 only: has received prior anti-PD-1/L-1 therapy