Open Actively Recruiting

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


Brief 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.

Primary Purpose
Study Type
Phase I


Healthy Volunteers
Minimum Age
18 Years
Maximum Age

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

Join this Trial

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Study Stats
Protocol No.
Bladder Cancer
Esophageal Cancer
Head and Neck Cancer
Kidney Cancer
Liver Cancer
Lung Cancer
Melanoma (Skin Cancer)
Ovarian Cancer
Pancreatic Cancer
Stomach Cancer
Uterine/Endometrial Cancer
Shenetra Walker
  • UCLA Santa Monica
For Providers
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