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

Prior treatment

• Any immune-related medical conditions that would put participants at greater risk when receiving pembrolizumab
• Has received prior radiotherapy within 2 weeks for palliative bone-directed therapy and 4 weeks for all other radiotherapy
• Has undergone major surgery within 4 weeks prior to the first dose of study treatment or has not adequately recovered from surgery or related complications
• Has a diagnosis of immunodeficiency or use of systemic steroids \>10 mg/day
• Has received a live or live-attenuated vaccine within 30 days or a non-live vaccine within 7 days prior to the first dose of PLN-101095

Other illness

• Has a known additional malignancy that is progressing or has required active treatment within the past 2 years
• Has an active autoimmune disease that has required systemic treatment in the past 2 years
• Has significant cardiac disease
• Has an active infection requiring systemic therapy (including uncontrolled HIV, Hepatitis B and C)

Other

• Has known active CNS metastases (brain and/or leptomeningeal metastases)

• Has histologically or cytologically confirmed advanced or metastatic solid tumor
• Have received ≥12 weeks of continuous anti-PD-1 or anti-PD-L1 treatment administered as monotherapy or in combination with other anticancer therapies
• Have demonstrated documented prior clinical benefit, defined as CR or PR at any time during treatment, or SD lasting ≥6 months (Part 2 only)
• Must have subsequently developed radiographic disease progression while receiving anti-PD-1 or anti-PD-L1 treatment or within ≤12 weeks after the last dose of such treatment
• At least 1 measurable lesion, as defined by RECIST v1.1
• Estimated survival of ≥3 months
• Have adequate bone marrow and organ function.
• A female participant is eligible to participate if she is not pregnant, not breastfeeding