Ovarian Cancer Clinical Trial
Study of PF-06940434 in Patients With Advanced or Metastatic Solid Tumors.
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 2 cohorts at doses determined from Part 1B in order to further evaluate the safety of PF-06940434 in combination with anti-PD-1.
Eligibility Criteria
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
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There are 25 Locations for this study
Scottsdale Arizona, 85258, United States
Scottsdale Arizona, 85258, United States
Los Angeles California, 90095, United States
Los Angeles California, 90095, United States
Los Angeles California, 90095, United States
Baltimore Maryland, 21201, United States
Creve Coeur Missouri, 63141, United States
Saint Louis Missouri, 63110, United States
Saint Louis Missouri, 63110, United States
Saint Louis Missouri, 63129, United States
Saint Louis Missouri, 63136, United States
Saint Peters Missouri, 63376, United States
Lake Success New York, 11042, United States
Lake Success New York, 11042, United States
Durham North Carolina, 27710, United States
Durham North Carolina, 27710, United States
Houston Texas, 77030, United States
San Antonio Texas, 78229, United States
Seattle Washington, 98195, United States
Liverpool New South Wales, 2170, Australia
Wollongong New South Wales, 2500, Australia
Seoul Seoul-teukbyeolsi [seoul], 05505, Korea, Republic of
Seoul , 03722, Korea, Republic of
Bratislava , 812 5, Slovakia
Bratislava , 82101, Slovakia
Bratislava , 833 4, Slovakia
Poprad , 058 0, Slovakia
Poprad , 058 0, Slovakia
Poprad , 05801, Slovakia
Poprad , 05801, Slovakia
Tainan , 70403, Taiwan
Taipei , 100, Taiwan
Taipei , 11217, Taiwan
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