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

Complete Title: A PHASE 1 STUDY TO EVALUATE THE SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF ESCALATING DOSES OF PF-06940434 IN PATIENTS WITH ADVANCED OR METASTATIC SOLID TUMORS
Trial Phase: I
Investigator: John Thompson, MD

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.

Keywords:
  • Bile Duct Cancer
  • Endometrial Cancer
  • Esophageal Cancer
  • Gastric Cancer
  • Melanoma
  • Ovarian Cancer
  • Pancreatic Cancer
  • Carcinoma, Squamous Cell
  • Urothelial Cancer
  • Carcinoma, Renal Cell
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Adult
I
John Thompson, MD
RG1006384
NCT04152018
A PHASE 1 STUDY TO EVALUATE THE SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF ESCALATING DOSES OF PF-06940434 IN PATIENTS WITH ADVANCED OR METASTATIC SOLID TUMORS
Bile Duct Cancer
Endometrial Cancer
Esophageal Cancer
Gastric Cancer
Melanoma
Ovarian Cancer
Pancreatic Cancer
Carcinoma, Squamous Cell
Urothelial Cancer
Carcinoma, Renal Cell