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

NCT ID: NCT04152018

Last Updated: 2025-05-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-13

Study Completion Date

2024-12-10

Brief Summary

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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.

Detailed Description

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Conditions

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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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dose Escalation

Single Agent Dose Escalation

Group Type EXPERIMENTAL

PF-06940434

Intervention Type DRUG

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

Dose Finding Anti-PD-1 Combination 1

Part 1B PF-06940434 plus anti-PD-1

Group Type EXPERIMENTAL

PF-06940434

Intervention Type DRUG

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

Intervention Type DRUG

PF-06801591 will be administered subcutaneously on Day 1 of each 28 day cycle or Day 1 of each 21 day cycle.

Dose Expansion Arm A

PF-06940434 with anti-PD-1 in SCCHN

Group Type EXPERIMENTAL

PF-06940434

Intervention Type DRUG

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

Intervention Type DRUG

PF-06801591 will be administered subcutaneously on Day 1 of each 28 day cycle or Day 1 of each 21 day cycle.

Dose Expansion Arm B

PF-06940434 with anti-PD-1 in RCC

Group Type EXPERIMENTAL

PF-06940434

Intervention Type DRUG

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

Intervention Type DRUG

PF-06801591 will be administered subcutaneously on Day 1 of each 28 day cycle or Day 1 of each 21 day cycle.

Dose Expansion, Arm C

PF-06940434 with anti-PD-1 (both Q3W)

Group Type EXPERIMENTAL

PF-06940434

Intervention Type DRUG

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

Intervention Type DRUG

PF-06801591 will be administered subcutaneously on Day 1 of each 28 day cycle or Day 1 of each 21 day cycle.

Interventions

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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

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Anti-PD-1

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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HonorHealth Research Institute

Scottsdale, Arizona, United States

Site Status

HonorHealth Scottsdale Shea Medical Center

Scottsdale, Arizona, United States

Site Status

Ronald Reagan UCLA Medical Center

Los Angeles, California, United States

Site Status

UCLA Hematology Oncology

Los Angeles, California, United States

Site Status

UCLA Hematology/Oncology

Santa Monica, California, United States

Site Status

Greenebaum Comprehensive Cancer Center

Baltimore, Maryland, United States

Site Status

Siteman Cancer Center - St. Peters

City of Saint Peters, Missouri, United States

Site Status

Siteman Cancer Center - West County

Creve Coeur, Missouri, United States

Site Status

Siteman Cancer Center - North County

Florissant, Missouri, United States

Site Status

Barnes-Jewish Hospital

St Louis, Missouri, United States

Site Status

Washington University School of Medicine Siteman Cancer Center

St Louis, Missouri, United States

Site Status

Siteman Cancer Center - South County

St Louis, Missouri, United States

Site Status

Duke Univ. Medical Center/Duke Cancer Center

Durham, North Carolina, United States

Site Status

Investigational Chemotherapy Service

Durham, North Carolina, United States

Site Status

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Site Status

NEXT Oncology

San Antonio, Texas, United States

Site Status

Fred Hutchinson Cancer Center

Seattle, Washington, United States

Site Status

University of Washington Medical Center

Seattle, Washington, United States

Site Status

Southern Medical Day Care Centre

Wollongong, New South Wales, Australia

Site Status

Onkologicky ustav sv. Alzbety, s.r.o.

Bratislava, , Slovakia

Site Status

Univerzitna nemocnica Bratislava

Bratislava, , Slovakia

Site Status

Narodny ustav srdcovych a cievnych chorob, a.s.

Bratislava, , Slovakia

Site Status

MR Poprad s.r.o.

Komárno, , Slovakia

Site Status

KARDIO, s.r.o.

Poprad, , Slovakia

Site Status

POKO Poprad, s.r.o., Ambulancia klinickej onkologie

Poprad, , Slovakia

Site Status

Nemocnica Poprad a.s.

Poprad, , Slovakia

Site Status

Asan Medical Center

Seoul, Seoul-teukbyeolsi [seoul], South Korea

Site Status

Severance Hospital, Yonsei University Health System

Seoul, , South Korea

Site Status

National Cheng Kung University Hospital

Tainan City, , Taiwan

Site Status

National Taiwan University Hospital

Taipei, , Taiwan

Site Status

Taipei Veterans General Hospital

Taipei, , Taiwan

Site Status

Countries

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United States Australia Slovakia South Korea Taiwan

Related Links

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https://pmiform.com/clinical-trial-info-request?StudyID=C3891001

To obtain contact information for a study center near you, click here.

Other Identifiers

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2020-004009-29

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

C3891001

Identifier Type: -

Identifier Source: org_study_id

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