A Clinical Trial of PF-08046037 Alone or With Sasanlimab in Patients With Advanced or Metastatic Malignancies

Inclusion Criteria

• •This study is seeking participants who have the following tumor types and can provide tumor tissue samples as per below.
• •1. Tumor types
• •* Monotherapy Dose Escalation (Part 1a) and Optimization (Part 2a) cohorts
• •* Advanced or metastatic NSCLC, HNSCC, melanoma, or PDAC
• •* Must have progressive disease following at least 1 prior approved systemic therapy
• •* Monotherapy Dose Expansion (Part 3a)
• •• Advanced or metastatic NSCLC or PDAC
• •* Combination Safety Evaluation (Part 1b) and Dose Optimization (Part 2b)
• •* Advanced or metastatic NSCLC or HNSCC
• •* May be either a) not received prior immunotherapy for the tumor type OR b) relapse/ refractory after prior immunotherapy
• •* Combination Dose Expansion (Part 3b)
• •* Unresectable locally advanced or metastatic HNSCC or NSCLC
• •* Must not have received prior systemic cytotoxic therapy in the locally advanced or metastatic setting (first-line setting)
• •* Must be treatment naïve to any immunotherapy
• •* NSCLC must have PD-L1 expression TPS \>=50%
• •* HNSCC must have PD-L1 expression CPS \>=1
• •2. Tissue requirement
• •* Part 1 at lower doses: sufficient archival tissue collected within 12 months of enrollment for submission to central laboratory
• •* Part 1 at higher doses: de novo baseline tumor biopsy or archival tissue within 12 months of enrollment
• •* Part 1 backfill: de novo baseline and on-treatment tumor biopsies are required
• •* Part 2 and 3: de novo baseline or archival tissue within 6 months of enrollment
• •* Part 2 and 3: mandatory on-treatment tumor biopsy, if required by sponsor
• •3. Measurable disease per RECIST v1.1
• •Participants who meet the following might not be able to participate.
• •1. History of Grade \>=3 immune mediated AE related to prior immune modulatory therapy and required immunosuppressive therapy
• •2. Active or prior autoimmune disease that might deteriorate when receiving an immunostimulatory agent
• •3. History of uveitis within the preceding 6 months
• •4. Clinically significant Grade \>=3 neurodegenerative disease
• •5. Grade 3 or higher pulmonary disease unrelated to underlying malignancy
• •6. Previous exposure to an investigational immunostimulatory antibody conjugate or systemic TLR agonist