Study Of PF-06940434 In Patients With Advanced Or Metastatic Solid Tumors.

Study Overview

Study 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.

N/A

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

DRUG: PF-06940434
DRUG: PF-06801591

C3891001
2020-004009-29 (EUDRACT_NUMBER Identifier) (EUDRACT_NUMBER: )

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2019-10-30	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-05-23
First Submitted that Met QC Criteria 2019-11-02	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-05-28
First Posted (ACTUAL) 2019-11-05	Results First Posted N/A	Last Verified 2025-05

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Sequential

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Dose Escalation Single Agent Dose Escalation	DRUG: PF-06940434 PF-06940434 is given intravenously (IV) every 2 or 4 weeks in a 28 day cycle or every 3 weeks in a 21 day cycle. Multiple dose levels will be evaluated
EXPERIMENTAL: Dose Finding Anti-PD-1 Combination 1 Part 1B PF-06940434 plus anti-PD-1	DRUG: PF-06940434 PF-06940434 is given intravenously (IV) every 2 or 4 weeks in a 28 day cycle or every 3 weeks in a 21 day cycle. Multiple dose levels will be evaluated DRUG: PF-06801591 PF-06801591 will be administered subcutaneously on Day 1 of each 28 day cycle or Day 1 of each 21 day cycle.
EXPERIMENTAL: Dose Expansion Arm A PF-06940434 with anti-PD-1 in SCCHN	DRUG: PF-06940434 PF-06940434 is given intravenously (IV) every 2 or 4 weeks in a 28 day cycle or every 3 weeks in a 21 day cycle. Multiple dose levels will be evaluated DRUG: PF-06801591 PF-06801591 will be administered subcutaneously on Day 1 of each 28 day cycle or Day 1 of each 21 day cycle.
EXPERIMENTAL: Dose Expansion Arm B PF-06940434 with anti-PD-1 in RCC	DRUG: PF-06940434 PF-06940434 is given intravenously (IV) every 2 or 4 weeks in a 28 day cycle or every 3 weeks in a 21 day cycle. Multiple dose levels will be evaluated DRUG: PF-06801591 PF-06801591 will be administered subcutaneously on Day 1 of each 28 day cycle or Day 1 of each 21 day cycle.
EXPERIMENTAL: Dose Expansion, Arm C PF-06940434 with anti-PD-1 (both Q3W)	DRUG: PF-06940434 PF-06940434 is given intravenously (IV) every 2 or 4 weeks in a 28 day cycle or every 3 weeks in a 21 day cycle. Multiple dose levels will be evaluated DRUG: PF-06801591 PF-06801591 will be administered subcutaneously on Day 1 of each 28 day cycle or Day 1 of each 21 day cycle.

Primary Outcome Measures	Measure Description	Time Frame
Number of participants with Dose-limiting toxicities (DLT) for Dose Escalation and Dose Finding		Baseline up to 28 Days (Cycle 1)
Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities		Baseline up to approximately 24 months
Number of Participants With Adverse Events (AEs) According to Severity		Baseline up to approximately 24 months
Number of Participants With Adverse Events (AEs) According to Seriousness		Baseline up to up to approximately 24 months
Number of Participants With Adverse Events (AEs) by Relationship		Baseline up to approximately 24 months
Progression-Free Survival (PFS) for Dose Expansion	The period from study entry until disease progression, death or date of last contact.	Baseline up to 24 Months
Objective Response Rate - Percentage of Participants With Objective Response in Dose Expansion		Baseline up to 24 months
Duration of Response (DR) for Dose Expansion		Baseline up to 24 Months

Secondary Outcome Measures	Measure Description	Time Frame
PF-06940434 after multiple doses PK parameters (Cmax).	Maximum observed plasma concentration of PF-06940434.	Pre-dose on Cycle 1 Day 1 and on days 3, 8, and 15 of Cycle 1; Day 1 and Day 15 of Cycles 2 and 3; Days 1, 3, 8, and 15 of Cycle 4 and Pre-dose on Day 1 of every cycle thereafter and at end of treatment (each cycle is 28 days).
Area under the curve from time zero extrapolated to the last quantifiable dose of PF-06940434.	Time zero extrapolated to the last quantifiable time point prior to the next dose.	Pre-dose on Cycle 1 Day 1 and on days 3, 8, and 15 of Cycle 1; Day 1 and Day 15 of Cycles 2 and 3; Days 1, 3, 8, and 15 of Cycle 4 and Pre-dose on Day 1 of every cycle thereafter and at end of treatment (each cycle is 28 days).
Systemic Clearance (CL)	CL is a quantitative measure of the rate at which a drug substance is removed from the body.	Pre-dose on Cycle 1 Day 1 and on days 3, 8, and 15 of Cycle 1; Day 1 and Day 15 of Cycles 2 and 3; Days 1, 3, 8, and 15 of Cycle 4 and Pre-dose on Day 1 of every cycle thereafter and at end of treatment (each cycle is 28 days).
Volume of Distribution (Vd)		Pre-dose on Cycle 1 Day 1 and on days 3, 8, and 15 of Cycle 1; Day 1 and Day 15 of Cycles 2 and 3; Days 1, 3, 8, and 15 of Cycle 4 and Pre-dose on Day 1 of every cycle thereafter and at end of treatment (each cycle is 28 days).
Incidence and titers of anti-drug antibodies (ADA) against PF-06940434.		Pre-dose on Days 1 and 15 of Cycle 1, pre-dose on Day 1 of Cycles 2 and 3, pre-dose on Day 1 of Cycle 4, pre-dose on Day 1 of every cycle thereafter and at end of treatment (each cycle is 28 days).
Incidence and titers of neutralizing antibodies (NAb) against PF-06940434.	Titers of neutralizing antibodies (NAb) against PF-06940434.	Pre-dose on Days 1 and 15 of Cycle 1, pre-dose on Day 1 of Cycles 2 and 3, pre-dose on Day 1 of Cycle 4, pre-dose on Day 1 of every cycle thereafter and at end of treatment (each cycle is 28 days).
PK parameters of PF-06940434 and PF-06801591 (Cmax).	Maximum observed plasma concentration after multiple doses of PF-06940434 and PD-1 (PF-06801591).	Pre-dose on Cycle 1 Day 1 and on day 15 of Cycle 1; Day 1 of Cycles 2 and 3; Days 1, 3, 8, and 15 of Cycle 4 and Pre-dose on Day 1 of every cycle thereafter and at end of treatment (each cycle is 28 days)
Area under the curve from time zero extrapolated to the last quantifiable dose of PF-06940434 and PF-06801591.	Area under the curve from time zero extrapolated to the last quantifiable dose of PF-06940434 and PF-06801591.	Pre-dose on Cycle 1 Day 1 and on day 15 of Cycle 1; Day 1 of Cycles 2 and 3; Days 1, 3, 8, and 15 of Cycle 4 and Pre-dose on Day 1 of every cycle thereafter and at end of treatment (each cycle is 28 days)
Characterize the multiple dose PK of PF-06940434 following intravenous administration in combination with PF-06801591.	Maximum observed plasma concentration of PF-06940434.	Cycle 4 Day 1 (each cycle is 28 days)
Area under the curve from time zero extrapolated to the last quantifiable dose of PF-06940434.	Time zero extrapolated to the last quantifiable time point prior to the next dose.	Cycle 4 Day 1 (each cycle is 28 days)
Number of participants with increased T-cells after PF-06940434 treatment.		Pre-dose on Day 1 of Cycle 1; pre-dose on Day 1 of Cycles 2 and 3 (each cycle is 28 days)
Progression-Free Survival (PFS) for Dose Expansion	The period from study entry until disease progression, death or date of last contact.	Baseline to measured progression (up to approximately 24 months)
Duration of Response (DR)		Baseline up to approximately 24 Months
Number of Participants With Objective Response for Dose Expansion portion		Baseline up to 24 months
Disease Control Rate (DCR)	DCR is defined as the percent of participants with a confirmed complete response (CR), partial response (PR) or stable disease (SD) according to RECIST 1.1.	Every 8 weeks from the time of enrollment up to 2 years
Trough concentrations of PF-06940434 and PF-06801591 in Dose Expansion		Day 1 of Cycle 1 though 4, Day 1 of every 2 Cycles starting from Cycle 5 up to 24 months (each cycle is 28 days). For Part 2 Cohort 3, Day 1 of Every Cycle (each cycle is 21 days)
Plasma Decay Half-Life (t1/2)	Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.	Pre-dose on Cycle 1 Day 1 and on days 3, 8, and 15 of Cycle 1; Day 1 and Day 15 of Cycles 2 and 3; Days 1, 3, 8, and 15 of Cycle 4 and Pre-dose on Day 1 of every cycle thereafter and at end of treatment (up to 24 Months) [each cycle is 28 days]
Incidence and titers of anti-drug antibodies (ADA) against PF-06801591 in Dose Finding and Dose Expansion	Incidence and titers of anti-drug antibodies (ADA) against PF-06801591.	Pre-dose on Days 1 and 15 of Cycle 1, pre-dose on Day 1 of Cycles 2 and 3, pre-dose on Day 1 of Cycle 4, pre-dose on Day 1 of every cycle thereafter and at end of treatment (up to 24 Months) [each cycle is 28 days].
Incidence and titers of neutralizing antibodies (NAb) against PF-06801591 in Dose Finding and Dose Expansion.	Incidence and titers of neutralizing antibodies (NAb) against PF-06801591.	Pre-dose on Days 1 and 15 of Cycle 1, pre-dose on Day 1 of Cycles 2 and 3, pre-dose on Day 1 of Cycle 4, pre-dose on Day 1 of every cycle thereafter and at end of treatment (up to 24 Months) [each cycle is 28 days].
Overall Survival	The period from study entry until death or date of last contact (24 months)	From baseline to up to 2 years after last dose of study drug

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

STUDY_DIRECTOR: Pfizer CT.gov Call Center, Pfizer

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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Clinical Trial Record