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Study of PF-06940434 in Patients With Advanced or Metastatic Solid Tumors.

Trial Status: Active

Open-label, multi-center, non-randomized, multiple dose, safety, tolerability, pharmacokinetic, and pharmacodynamics and clinical activity study of PF-06940434 in patients with SCCHN (Squamous Cell Carcinoma of the Head and Neck), renal cell carcinoma (RCC - clear cell and papillary), ovarian, gastric, esophageal, esophageal (adeno and squamous), lung squamous cell, pancreatic and biliary duct, endometrial, melanoma and urothelial tumors. This study contains two parts, single agent dose escalation (Part 1A), dose finding of PF 06940434 in combination with anti-PD-1 (Part 1B), biopsy cohorts with monotherapy lead-in at the maximum tolerated dose (MTD) or maximum administered dose (MAD), followed by combination of anti-PD-1 [PF-06801591] (Part 1C) followed by dose expansion (Part 2). Part 2 Dose Combination Expansion will enroll participants into 2 cohorts at doses determined from Part 1B in order to further evaluate the safety of PF-06940434 in combination with anti-PD-1.

Inclusion Criteria

  • Histological or cytological diagnosis of SCCHN, RCC (clear cell and papillary cell), ovarian, gastric, esophageal (adeno and squamous), lung squamous cell, pancreatic and biliary duct, endometrial, melanoma, or urothelial cancer.
  • Adequate bone marrow, kidney and liver function.
  • Performance status of 0 or 1.

Exclusion Criteria

  • Participant disease status is suitable for local therapy administered with curative intent.
  • Hypertension that cannot be controlled by medications.

California

Los Angeles
UCLA / Jonsson Comprehensive Cancer Center
Status: ACTIVE
Contact: Lia Etheridge
Phone: 310-825-7174

Missouri

Saint Louis
Siteman Cancer Center at Washington University
Status: ACTIVE

Texas

Houston
M D Anderson Cancer Center
Status: ACTIVE

Washington

Seattle
Fred Hutch / University of Washington Cancer Consortium
Status: ACTIVE

Trial Phase Phase I

Trial Type Treatment

Lead Organization
Pfizer Inc

  • Primary ID C3891001
  • Secondary IDs NCI-2019-08794, 2020-004009-29
  • Clinicaltrials.gov ID NCT04152018