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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02573259.
Protocol B8011001 is a Phase 1, two part, open-label, multi center, multiple-dose,
safety, efficacy, PK, and PD study of PF-06801591 administered intravenously (IV) or
subcutaneous (SC) in previously treated adult patients with locally advanced or
metastatic melanoma, squamous cell carcinoma head and neck (SCCHN), ovarian carcinoma,
sarcoma, non-small cell lung carcinoma (NSCLC), urothelial carcinoma or other solid
tumors.
The first part of the study, Part 1 dose escalation, was designed to assess the safety
and tolerability of increasing dose levels of IV or SC administered PF-06801591 to
establish the maximum tolerated dose (MTD) using a modified Toxicity Probability Interval
(mTPI) design. Part 2 expansion is designed to further evaluate the safety and efficacy
of 300 mg of PF-06801591 administered SC once every 4 weeks in patients with NSCLC or
urothelial carcinoma as well as confirm the recommended Phase 2 dose (RP2D). Part 1
enrollment has completed, enrollment will only be allowed for Part 2.
Lead OrganizationPfizer Inc