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

Stopped early · Phase 1

Conditions studied: 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

In brief

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.

Key facts

Study ID

NCT04152018

Run by

Pfizer

People needed

85

Starts

2019-11-13

Expected to finish

2024-12-10

Last updated by the study team

2025-05-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Part 2:
• Arm A SCCHN:
• Primary tumor location of the oral cavity, oropharynx, hypopharynx or larynx.
• PDL-1 expression positive and CPS ≥1. No prior systemic therapy administered in the recurrent or metastatic setting (except for systemic therapy given as part of a multimodal treatment for locally advanced disease).
• Arm B RCC (clear cell):
• 1 or 2 prior lines of therapy including PD-L1/PD-1 immunotherapy in combination or sequentially with antiangiogenic directed treatment
• Adequate bone marrow, kidney and liver function.
• Performance status of 0 or 1.

You may not qualify if…

• Participant disease status is suitable for local therapy administered with curative intent.
• Hypertension that cannot be controlled by medications.
• Active or prior autoimmune disease
• Active, uncontrolled bacterial, fungal, or viral infection, including (but not limited to) Hepatitis B, Hepatitis C, and known Human Immunodeficiency Virus infection or Acquired Immunodeficiency Syndrome-related illness

Where it is running

• HonorHealth Research Institute — Scottsdale, Arizona, United States
• HonorHealth Scottsdale Shea Medical Center — Scottsdale, Arizona, United States
• Ronald Reagan UCLA Medical Center — Los Angeles, California, United States
• UCLA Hematology Oncology — Los Angeles, California, United States
• UCLA Hematology/Oncology — Santa Monica, California, United States
• Greenebaum Comprehensive Cancer Center — Baltimore, Maryland, United States
• Siteman Cancer Center - St. Peters — City of Saint Peters, Missouri, United States
• Siteman Cancer Center - West County — Creve Coeur, Missouri, United States
• Siteman Cancer Center - North County — Florissant, Missouri, United States
• Barnes-Jewish Hospital — St Louis, Missouri, United States
• Washington University School of Medicine Siteman Cancer Center — St Louis, Missouri, United States
• Siteman Cancer Center - South County — St Louis, Missouri, United States
• Duke Univ. Medical Center/Duke Cancer Center — Durham, North Carolina, United States
• Investigational Chemotherapy Service — Durham, North Carolina, United States
• The University of Texas MD Anderson Cancer Center — Houston, Texas, United States
• NEXT Oncology — San Antonio, Texas, United States
• Fred Hutchinson Cancer Center — Seattle, Washington, United States
• University of Washington Medical Center — Seattle, Washington, United States
• Southern Medical Day Care Centre — Wollongong, New South Wales, Australia
• Onkologicky ustav sv. Alzbety, s.r.o. — Bratislava, Slovakia
• Univerzitna nemocnica Bratislava — Bratislava, Slovakia
• Narodny ustav srdcovych a cievnych chorob, a.s. — Bratislava, Slovakia
• MR Poprad s.r.o. — Komárno, Slovakia
• KARDIO, s.r.o. — Poprad, Slovakia
• POKO Poprad, s.r.o., Ambulancia klinickej onkologie — Poprad, Slovakia

Full record on ClinicalTrials.gov

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