A Phase 1 Study of PLN-101095 in Adults With Advanced or Metastatic Solid Tumors

Inclusion Criteria

• Has histologically or cytologically confirmed advanced solid tumor
• Has an advanced or metastatic solid tumor (for which pembrolizumab is indicated) and have evidence of disease progression after treatment with pembrolizumab.
• At least 1 measurable lesion, as defined by RECIST v1.1
• Estimated survival of ≥3 months
• No effective therapeutic options available (eg, has received standard of care or is intolerant of, refuses, or is not eligible for standard of care antineoplastic therapy)

Exclusion Criteria

• Any immune-related medical conditions that would put participants at greater risk when receiving pembrolizumab
• Previous treatment with pembrolizumab <21 days prior to the first dose of combination therapy of pembrolizumab and PLN-101095
• Received an immunotherapy other than pembrolizumab in the last 4 weeks prior to the first dose of PLN-101095
• Received radiotherapy (RT) within 1 week for palliative bone-directed therapy and 4 weeks for all other types, prior to the first dose of PLN-101095
• Received chemotherapy or other targeted therapies within 2 weeks prior to the first dose of PLN-101095
• Received a cell therapy within the last 12 months prior to the first dose of PLN-101095
• Known active central nervous system (CNS) metastases (brain and/or leptomeningeal metastases)
• Pregnant or lactating female participant