Study of PF-06940434 in Patients With Advanced or Metastatic Solid Tumors.
NCT04152018 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 85
Last updated 2025-05-28
Summary
Open-label, multi-center, non-randomized, multiple dose, safety, tolerability, pharmacokinetic, and pharmacodynamics and clinical activity study of PF-06940434 (Integrin alpha-V/beta-8 Antagonist) 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) and dose expansion (Part 2). Part 2 Dose Combination Expansion will enroll participants into 3 cohorts at doses determined from Part 1B in order to further evaluate the safety of PF-06940434 in combination with anti-PD-1.
Conditions
- Squamous Cell Carcinoma of the Head and Neck
- Renal Cell Carcinoma
- Ovarian Cancer
- Gastric Cancer
- Esophageal Cancer
- Lung Squamous Cell Carcinoma
- Pancreatic Cancer
- Bile Duct Cancer
- Endometrial Cancer
- Melanoma Cancer
- Urothelial Cancer
Interventions
- DRUG
-
PF-06940434
PF-06940434 is given intravenously (IV) every 2 or 4 weeks in a 28 day cycle or every 3 weeks in a 21 day cycle. Multiple dose levels will be evaluated
- DRUG
-
PF-06801591
PF-06801591 will be administered subcutaneously on Day 1 of each 28 day cycle or Day 1 of each 21 day cycle.
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Pfizer CT.gov Call Center · Pfizer
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-11-13
- Primary Completion
- 2024-12-10
- Completion
- 2024-12-10
- FDA Drug
- Yes
Countries
- United States
- Australia
- Slovakia
- South Korea
- Taiwan
Study Locations
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