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

Criteria the registry did not label

• This study is seeking participants who have the following tumor types and can provide tumor tissue samples as per below.
• 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
• 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
• Measurable disease per RECIST v1.1
  • Participants who meet the following might not be able to participate.
• History of Grade >=3 immune mediated AE related to prior immune modulatory therapy and required immunosuppressive therapy
• Active or prior autoimmune disease that might deteriorate when receiving an immunostimulatory agent
• History of uveitis within the preceding 6 months
• Clinically significant Grade >=3 neurodegenerative disease
• Grade 3 or higher pulmonary disease unrelated to underlying malignancy
• Previous exposure to an investigational immunostimulatory antibody conjugate or systemic TLR agonist