Study of PF-06940434 in Patients With Advanced or Metastatic Solid Tumors.
Megadott ok: Study termination was based on strategic considerations and not due to specific safety reasons or a request from a regulatory authority.
Key facts
- Where
- Baltimore, City of Saint Peters, Creve Coeur, Durham, Florissant, Houston, Los Angeles, San Antonio, Santa Monica, Scottsdale, Seattle és St Louis, Egyesült ÁllamokSee the 18 sites
- Phase
- 1. fázis
Where in Egyesült Államok
- Greenebaum Comprehensive Cancer CenterBaltimore, Egyesült ÁllamokNo longer taking part
- Siteman Cancer Center - St PetersCity of Saint Peters, Egyesült ÁllamokNo longer taking part
- Siteman Cancer Center - West CountyCreve Coeur, Egyesült ÁllamokNo longer taking part
- Duke Univ. Medical Center/Duke Cancer CenterDurham, Egyesült ÁllamokNo longer taking part
- Investigational Chemotherapy ServiceDurham, Egyesült ÁllamokNo longer taking part
- Siteman Cancer Center - North CountyFlorissant, Egyesült ÁllamokNo longer taking part
- The University of Texas MD Anderson Cancer CenterHouston, Egyesült ÁllamokNo longer taking part
- Ronald Reagan UCLA Medical CenterLos Angeles, Egyesült ÁllamokNo longer taking part
- UCLA Hematology-OncologyLos Angeles, Egyesült ÁllamokNo longer taking part
- NEXT OncologySan Antonio, Egyesült ÁllamokNo longer taking part
- UCLA Hematology/OncologySanta Monica, Egyesült ÁllamokNo longer taking part
- HonorHealth Research InstituteScottsdale, Egyesült ÁllamokNo longer taking part
- HonorHealth Scottsdale Shea Medical CenterScottsdale, Egyesült ÁllamokNo longer taking part
- Fred Hutchinson Cancer CenterSeattle, Egyesült ÁllamokNo longer taking part
- University of Washington Medical CenterSeattle, Egyesült ÁllamokNo longer taking part
- Barnes-Jewish HospitalSt Louis, Egyesült ÁllamokNo longer taking part
- Siteman Cancer Center-South CountySt Louis, Egyesült ÁllamokNo longer taking part
- Washington University School of Medicine - Siteman Cancer CenterSt Louis, Egyesült ÁllamokNo longer taking part
Trial details
- Who runs it
- Pfizer
- Trial code
- NCT04152018
- Record updated
- 2025. május 28.
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: Active or prior autoimmune disease; Participant disease status is suitable for local therapy administered with curative intent; Hypertension that cannot be controlled by medications; 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.