Protocol B8011001 is a Phase 1, open-label, multi-center, multiple-dose, dose escalation and expansion, safety, pharmacokinetics (PK), and pharmacodynamics (PD) study of PF-06801591 in previously treated adult patients with locally advanced or metastatic melanoma, SCCHN, ovarian carcinoma, sarcoma, NSCLC, urothelial carcinoma or other solid tumors. This is a 2 Part study whereby the safety and tolerability of increasing dose levels of intravenous (IV) or subcutaneous (SC) PF-06801591 was assessed in Part 1. Part 2 expansion is designed to further evaluate the safety and efficacy of SC PF-06801591 in patients with NSCLC or urothelial carcinoma as well as confirm the recommended Phase 2 dose.
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Percentage of Participants With Dose-Limiting Toxicities (DLT) - Part 1
Timeframe: Cycle 1 in Part 1 (21 days for IV administration of PF-06801591; 28 days for SC administration of PF-06801591)
Number of Participants With All-Causality Treatment-Emergent Adverse Events (AEs) - Part 1 and Part 2
Timeframe: Baseline up to 28 days after last dose of study treatment (maximum of 1634 days)
Number of Participants With Treatment-Related Treatment-Emergent Adverse Events (AEs) - Part 1 and Part 2
Timeframe: Baseline up to 28 days after last dose of study treatment (maximum of 1634 days)
Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2
Timeframe: Baseline up to 28 days after last dose of study treatment (maximum of 1634 days)
Objective Response Rate (ORR) Based on RECIST Version 1.1 - Part 2
Timeframe: Baseline up to end of treatment in Part 2 (maximum of 851 days)
Objective Response Rate (ORR) Based on Immune Related RECIST (irRECIST) - Part 2
Timeframe: Baseline up to end of treatment in Part 2 (maximum of 851 days)