Study Stopped
Study termination was based on strategic considerations and not due to specific safety reasons or a request from a regulatory authority.
Study of PF-06940434 in Patients With Advanced or Metastatic Solid Tumors.
A PHASE 1 STUDY TO EVALUATE THE SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF ESCALATING DOSES OF PF-06940434 IN PATIENTS WITH ADVANCED OR METASTATIC SOLID TUMORS
2 other identifiers
interventional
85
5 countries
31
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 3 cohorts at doses determined from Part 1B in order to further evaluate the safety of PF-06940434 in combination with anti-PD-1.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Nov 2019
Longer than P75 for phase_1
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 30, 2019
CompletedFirst Posted
Study publicly available on registry
November 5, 2019
CompletedStudy Start
First participant enrolled
November 13, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 10, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 10, 2024
CompletedMay 28, 2025
May 1, 2025
5.1 years
October 30, 2019
May 23, 2025
Conditions
Outcome Measures
Primary Outcomes (8)
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 Outcomes (20)
PF-06940434 after multiple doses PK parameters (Cmax).
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.
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)
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).
- +15 more secondary outcomes
Study Arms (5)
Dose Escalation
EXPERIMENTALSingle Agent Dose Escalation
Dose Finding Anti-PD-1 Combination 1
EXPERIMENTALPart 1B PF-06940434 plus anti-PD-1
Dose Expansion Arm A
EXPERIMENTALPF-06940434 with anti-PD-1 in SCCHN
Dose Expansion Arm B
EXPERIMENTALPF-06940434 with anti-PD-1 in RCC
Dose Expansion, Arm C
EXPERIMENTALPF-06940434 with anti-PD-1 (both Q3W)
Interventions
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
PF-06801591 will be administered subcutaneously on Day 1 of each 28 day cycle or Day 1 of each 21 day cycle.
Eligibility Criteria
You may qualify if:
- \- 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):
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (31)
HonorHealth Research Institute
Scottsdale, Arizona, 85258, United States
HonorHealth Scottsdale Shea Medical Center
Scottsdale, Arizona, 85260, United States
Ronald Reagan UCLA Medical Center
Los Angeles, California, 90095, United States
UCLA Hematology Oncology
Los Angeles, California, 90095, United States
UCLA Hematology/Oncology
Santa Monica, California, 90404, United States
Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, 21201, United States
Siteman Cancer Center - St. Peters
City of Saint Peters, Missouri, 63376, United States
Siteman Cancer Center - West County
Creve Coeur, Missouri, 63141, United States
Siteman Cancer Center - North County
Florissant, Missouri, 63031, United States
Barnes-Jewish Hospital
St Louis, Missouri, 63110, United States
Washington University School of Medicine Siteman Cancer Center
St Louis, Missouri, 63110, United States
Siteman Cancer Center - South County
St Louis, Missouri, 63129, United States
Duke Univ. Medical Center/Duke Cancer Center
Durham, North Carolina, 27710, United States
Investigational Chemotherapy Service
Durham, North Carolina, 27710, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
NEXT Oncology
San Antonio, Texas, 78229, United States
Fred Hutchinson Cancer Center
Seattle, Washington, 98109, United States
University of Washington Medical Center
Seattle, Washington, 98195, United States
Southern Medical Day Care Centre
Wollongong, New South Wales, 2500, Australia
Onkologicky ustav sv. Alzbety, s.r.o.
Bratislava, 812 50, Slovakia
Univerzitna nemocnica Bratislava
Bratislava, 82101, Slovakia
Narodny ustav srdcovych a cievnych chorob, a.s.
Bratislava, 833 48, Slovakia
MR Poprad s.r.o.
Komárno, 945 01, Slovakia
KARDIO, s.r.o.
Poprad, 058 01, Slovakia
POKO Poprad, s.r.o., Ambulancia klinickej onkologie
Poprad, 058 01, Slovakia
Nemocnica Poprad a.s.
Poprad, 058 45, Slovakia
Asan Medical Center
Seoul, Seoul-teukbyeolsi [seoul], 05505, South Korea
Severance Hospital, Yonsei University Health System
Seoul, 03722, South Korea
National Cheng Kung University Hospital
Tainan, 70403, Taiwan
National Taiwan University Hospital
Taipei, 100, Taiwan
Taipei Veterans General Hospital
Taipei, 11217, Taiwan
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 30, 2019
First Posted
November 5, 2019
Study Start
November 13, 2019
Primary Completion
December 10, 2024
Study Completion
December 10, 2024
Last Updated
May 28, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.