For Healthcare Professionals

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

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About the study

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.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION 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:


  1. Primary tumor location of the oral cavity, oropharynx, hypopharynx or larynx.
  2. 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. 1 or 2 prior lines of therapy including PD-L1/PD-1 immunotherapy in combination or sequentially with antiangiogenic directed treatment
  2. Adequate bone marrow, kidney and liver function.
  3. Performance status of 0 or 1.

EXCLUSION CRITERIA

Exclusion Criteria:


  1. Participant disease status is suitable for local therapy administered with curative intent.
  2. Hypertension that cannot be controlled by medications.
  3. Active or prior autoimmune disease
  4. 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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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.

Study’s details


Contition

Renal Cell Carcinoma,Squamous Cell Carcinoma of the Head and Neck,Ovarian Cancer,Gastric Cancer,Esophageal Cancer,Lung Squamous Cell Carcinoma,Pancreatic Cancer,Bile Duct Cancer,Endometrial Cancer,Melanoma Cancer,Urothelial Cancer

Age (in years)

18+

Phase

Phase 1

Participants needed

75

Est. Completion Date

Jul 31, 2024

Treatment type

Interventional


Sponsor

Pfizer

ClinicalTrials.gov identifier

NCT04152018

Study number

C3891001

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