Study of PF-06940434 in Patients With Advanced or Metastatic Solid Tumors.
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.
Checked against the public recordLast updated May 28, 2025 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- Pfizer
- Interventions being studied
- Drug: PF-06940434; Drug: PF-06801591
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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. 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. Exclusion Criteria: * 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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- HonorHealth Research InstituteScottsdale, Arizona
- HonorHealth Scottsdale Shea Medical CenterScottsdale, Arizona
- Ronald Reagan UCLA Medical CenterLos Angeles, California
- UCLA Hematology OncologyLos Angeles, California
- UCLA Hematology/OncologySanta Monica, California
- Greenebaum Comprehensive Cancer CenterBaltimore, Maryland
- Siteman Cancer Center - St. PetersCity of Saint Peters, Missouri
- Siteman Cancer Center - West CountyCreve Coeur, Missouri
- Siteman Cancer Center - North CountyFlorissant, Missouri
- Barnes-Jewish HospitalSt Louis, Missouri
- Washington University School of Medicine Siteman Cancer CenterSt Louis, Missouri
- Siteman Cancer Center - South CountySt Louis, Missouri
Source and freshness
Processed from ClinicalTrials.gov. Last public update: May 28, 2025. Always confirm current availability with the study team.