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

  • STATUS
    Recruiting
  • End date
    Sep 28, 2023
  • participants needed
    122
  • sponsor
    Pfizer
Updated on 7 October 2022
cancer
combination therapy
systemic therapy
carcinoma
squamous cell carcinoma
primary tumor
programmed cell death 1 ligand 1
solid tumour
squamous cell carcinoma of head and neck
pf-06801591
head and neck carcinoma

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.

Details
Condition Squamous Cell Carcinoma of the Head and Neck, Renal Cell Carcinoma, Ovarian Cancer, Gastric Cancer, Esophageal Cancer, Lung Squamous Cell Carcinoma, Pancreatic Cancer, Bile Duct Cancer, Endometrial Cancer, Melanoma Cancer, Urothelial Cancer
Treatment PF-06801591, PF-06940434
Clinical Study IdentifierNCT04152018
SponsorPfizer
Last Modified on7 October 2022

Eligibility

Yes No Not Sure

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
Adequate bone marrow, kidney and liver function
Part 2
Performance status of 0 or 1
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)
or 2 prior lines of therapy including PD-L1/PD-1 immunotherapy in combination or sequentially with antiangiogenic directed treatment

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
Clear my responses

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Step 1 Connect with a study center
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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