New hope for advanced kidney cancer: experimental drug enters human trials

NCT ID NCT07227415

Disease control Sponsor: Pfizer Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Sep 18, 2026 · Updated 4 times

Summary

This study tests a new medicine, PF-08634404, in adults with advanced kidney cancer that has spread. The goal is to see if the drug is safe and can shrink tumors when used alone or with other cancer drugs. About 224 participants who have not had prior treatment for their advanced cancer will receive the drug through an IV. This is an early-phase trial focused on safety and tumor response, not a cure.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 224 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2026

Expected to finish

Nov 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 18 years of age or older at screening * Locally advanced (not amenable to curative surgery or radiation therapy) or metastatic RCC with diagnosis confirmed by histology/cytology * At least one measurable (as defined by the investigator) and untreated lesion * Adequate hematologic, hepatic, cardiac and renal function * No prior systemic therapy for RCC (immunotherapy after surgery is allowed if received \>12 months prior) * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. * All International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) based risk categories Exclusion Criteria: Participants may be excluded if they meet any of the following: * Known active brain lesions including leptomeningeal metastasis, brainstem, meningeal or spinal cord metastases or compression. * Clinically significant risk of haemorrhage or fistula * History of another malignancy within 3 years * History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation. * active autoimmune diseases requiring systemic treatment within the past 2 years * uncontrolled cardiac and other comorbidities within 6 months prior to the first dose * Major surgery or severe trauma within 4 weeks before the first dose, or planned major surgery during the study * History of severe bleeding tendency or coagulation dysfunction * History of oesophageal varices, severe ulcers, gastrointestinal perforation, abdominal fistula, gastrointestinal obstruction, intra-abdominal abscess or acute gastrointestinal bleeding within 6 months prior to the first dose * Acute, chronic or symptomatic infections * Participants with history of immunodeficiency

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Conditions

The condition(s) this trial relates to.

carcinoma clear cell renal carcinoma Clear-cell metastatic renal cell carcinoma kidney cancer kidney neoplasm Neoplasm Metastasis nonpapillary renal cell carcinoma renal carcinoma renal cell adenocarcinoma renal cell carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced or metastatic renal cell carcinoma Advanced renal cell carcinoma Carcinoma, renal cell Carcinoma, renal cell metastasis Carcinoma, renal cell, advanced Clear cell renal cell carcinoma Clear-cell metastatic renal cell carcinoma Metastatic renal cell cancer Metastatic renal cell carcinoma Metastatic renal cell carcinoma ( MRCC) Metastatic/advanced renal cell carcinoma Renal cancer Renal neoplasm

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

162 sites in 6 countries. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

Barnes-Jewish Hospital
RECRUITING

St Louis, Missouri, 63110, United States
Beijing Cancer hospital
RECRUITING

Beijing, Beijing Municipality, 100142, China
Brigham and Women's Hospital
RECRUITING

Boston, Massachusetts, 02115, United States
Carolina Urologic Research Center, LLC
RECRUITING

Myrtle Beach, South Carolina, 29572, United States
Charité Universitaetsmedizin Berlin
NOT_YET_RECRUITING

Berlin, 10117, Germany
Chongqing University Cancer Hospital
NOT_YET_RECRUITING

Chongqing, Chongqing Municipality, 400030, China
City Of Hope - Chicago
RECRUITING

Zion, Illinois, 60099, United States
City of Hope
RECRUITING

Long Beach, California, 90813, United States
City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
RECRUITING

Duarte, California, 91010, United States
City of Hope Investigational Drug Services (IDS)
RECRUITING

Duarte, California, 91010, United States
City of Hope Investigational Drug Services (IDS)
RECRUITING

Irvine, California, 92618, United States
City of Hope UPLAND
RECRUITING

Upland, California, 91786, United States
City of Hope at Irvine Lennar
RECRUITING

Irvine, California, 92618, United States
Clinical and Translational Research Center(CTRC)
NOT_YET_RECRUITING

Aurora, Colorado, 80045, United States
Dana Farber/Mass General Brigham Cancer Care, Inc
RECRUITING

Boston, Massachusetts, 02215, United States
Dana-Farber Cancer Institute - Chestnut Hill
RECRUITING

Newton, Massachusetts, 02467, United States
Evelyn H. Lauder Breast and Imaging Center (BAIC)
RECRUITING

New York, New York, 10065, United States
Fred Hutchinson Cancer Center
RECRUITING

Seattle, Washington, 98109, United States
Grand Strand Medical Center
RECRUITING

Myrtle Beach, South Carolina, 295724607, United States
Henry-Joyce Cancer Clinic
NOT_YET_RECRUITING

Nashville, Tennessee, 37232, United States
Highlands Oncology Group
RECRUITING

Fayetteville, Arkansas, 72703, United States
Highlands Oncology Group
RECRUITING

Rogers, Arkansas, 72758, United States
Highlands Oncology Group, PA
RECRUITING

Springdale, Arkansas, 72762, United States
Highlands Ranch Hospital
NOT_YET_RECRUITING

Highlands Ranch, Colorado, 80129, United States
Hospital Clinico San Carlos
RECRUITING

Madrid, 28040, Spain
Hospital Universitario 12 de Octubre
RECRUITING

Madrid, 28041, Spain
Hospital Universitario Fundación Jiménez Díaz
RECRUITING

Madrid, 28040, Spain
Hospital Universitario Virgen de la Victoria
RECRUITING

Málaga, Málaga, 29010, Spain
Hospital de la Santa Creu i Sant Pau
RECRUITING

Barcelona, Catalunya [cataluña], 08041, Spain
Hunan Cancer Hospital
RECRUITING

Changsha, Hunan, 410013, China
Icahn School of Medicine at Mount Sinai
RECRUITING

New York, New York, 10029, United States
Icon Cancer Centre Wesley
RECRUITING

Auchenflower, Queensland, 4066, Australia
Keio university hospital
RECRUITING

Shinjuku-ku, Tokyo, 1608582, Japan
MSK Basking Ridge
RECRUITING

Basking Ridge, New Jersey, 07920, United States
MSK Bergen
RECRUITING

Montvale, New Jersey, 07645, United States
MSK Commack
RECRUITING

Commack, New York, 11725, United States
MSK Monmouth
RECRUITING

Middletown, New Jersey, 07748, United States
MSK Nassau
RECRUITING

Uniondale, New York, 11553, United States
MSK Westchester
RECRUITING

Harrison, New York, 10604, United States
Mayo Clinic Arizona
RECRUITING

Scottsdale, Arizona, 85259, United States
Mayo Clinic Building- Phoenix
RECRUITING

Phoenix, Arizona, 85054, United States
Mayo Clinic Cancer Center Outpatient Pharmacy
RECRUITING

Rochester, Minnesota, 55905, United States
Mayo Clinic Hospital, Methodist Campus, Research Pharmacy
RECRUITING

Rochester, Minnesota, 55902, United States
Mayo Clinic Pharmacy
RECRUITING

Jacksonville, Florida, 32224, United States
Memorial Hospital
RECRUITING

Shiloh, Illinois, 62269, United States
Memorial Sloan Kettering Cancer Center - Investigational Drug Service Pharmacy
RECRUITING

Long Island City, New York, 11101, United States
Memorial Sloan Kettering Cancer Center - Main Campus
RECRUITING

New York, New York, 10065, United States
Minnesota Oncology Hematology, P.A.
RECRUITING

Burnsville, Minnesota, 55337, United States
Minnesota Oncology Hematology, P.A.
RECRUITING

Chaska, Minnesota, 55318, United States
Minnesota Oncology Hematology, P.A.
RECRUITING

Coon Rapids, Minnesota, 55433, United States
Minnesota Oncology Hematology, P.A.
RECRUITING

Edina, Minnesota, 55435, United States
Minnesota Oncology Hematology, P.A.
RECRUITING

Maple Grove, Minnesota, 55369, United States
Minnesota Oncology Hematology, P.A.
RECRUITING

Maplewood, Minnesota, 55109, United States
Minnesota Oncology Hematology, P.A.
RECRUITING

Woodbury, Minnesota, 55125, United States
Minnesota Oncology Hematology, P.A.
RECRUITING

Hudson, Wisconsin, 54016, United States
Monash Health
RECRUITING

Clayton, Victoria, 3168, Australia
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
RECRUITING

Nanjing, Jiangsu, 210008, China
National Hospital Organization Kyushu Cancer Center
RECRUITING

Fukuoka, 811-1395, Japan
New York Oncology Hematology - Clifton Park Cancer Center
RECRUITING

Clifton Park, New York, 12065, United States
New York Oncology Hematology, P.C.
RECRUITING

Albany, New York, 12206, United States
Northwest Cancer Specialists, P.C.
RECRUITING

Portland, Oregon, 97227, United States
Northwest Cancer Specialists, P.C.
RECRUITING

Vancouver, Washington, 98684, United States
Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
RECRUITING

Blacksburg, Virginia, 24060, United States
Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
RECRUITING

Low Moor, Virginia, 24457, United States
Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
RECRUITING

Roanoke, Virginia, 24014, United States
Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
RECRUITING

Salem, Virginia, 24153, United States
Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
RECRUITING

Wytheville, Virginia, 24382, United States
Orlando Health Ambulatory Care Center
RECRUITING

Orlando, Florida, 32806, United States
Orlando Health Cancer Institute
RECRUITING

Orlando, Florida, 32806, United States
Orlando Health Orlando Regional Medical Center
RECRUITING

Orlando, Florida, 32806, United States
Parkway Surgery Center
RECRUITING

Myrtle Beach, South Carolina, 29572, United States
Qilu Hospital of Shandong University
RECRUITING

Jinan, Shandong, 250012, China
Rocky Mountain Cancer Centers, LLP
RECRUITING

Lakewood, Colorado, 80228, United States
Rocky Mountain Cancer Centers,LLP
RECRUITING

Aurora, Colorado, 80012, United States
Rocky Mountain Cancer Centers,LLP
RECRUITING

Denver, Colorado, 80218, United States
Rocky Mountain Cancer Centers,LLP
RECRUITING

Lone Tree, Colorado, 80124, United States
SCRI Oncology Partners
RECRUITING

Nashville, Tennessee, 37203, United States
Sarah Cannon Research Institute
RECRUITING

Nashville, Tennessee, 37203, United States
Sidney Kimmel Center for Prostate and Urological Cancers - Memorial Sloan Kettering Cancer Center
RECRUITING

New York, New York, 10065, United States
Siteman Cancer Center
RECRUITING

St Louis, Missouri, 63108, United States
Siteman Cancer Center - North County
RECRUITING

Florissant, Missouri, 63031, United States
Siteman Cancer Center - Shiloh
RECRUITING

Shiloh, Illinois, 62269, United States
Siteman Cancer Center - South County
RECRUITING

St Louis, Missouri, 63129, United States
Siteman Cancer Center - St. Peters
RECRUITING

City of Saint Peters, Missouri, 63376, United States
Siteman Cancer Center - West County
RECRUITING

Creve Coeur, Missouri, 63141, United States
Tennessee Oncology, PLLC - Chattanooga Med Park II
RECRUITING

Chattanooga, Tennessee, 37404, United States
Tennessee Oncology, PLLC - Chattanooga Memorial
RECRUITING

Chattanooga, Tennessee, 37404, United States
Tennessee Oncology, PLLC - Investigational Drug Services/Supply Storage
RECRUITING

Chattanooga, Tennessee, 37404, United States
Tennessee Oncology, PLLC- Chattanooga Downtown
RECRUITING

Chattanooga, Tennessee, 37403, United States
Tennessee Oncology, PLLC- Chattanooga East
RECRUITING

Chattanooga, Tennessee, 37421, United States
Tennessee Oncology, PLLC- Cookeville
RECRUITING

Cookeville, Tennessee, 38501, United States
Tennessee Oncology, PLLC- Elliston Place Plaza
RECRUITING

Nashville, Tennessee, 37203, United States
Tennessee Oncology, PLLC- Franklin Proton Center
RECRUITING

Franklin, Tennessee, 37067, United States
Tennessee Oncology, PLLC- Ringgold
RECRUITING

Ringgold, Georgia, 30736, United States
Tennessee Oncology, PLLC- Saint Thomas West
RECRUITING

Nashville, Tennessee, 37205, United States
Tennessee Oncology, PLLC- Shelbyville
RECRUITING

Shelbyville, Tennessee, 37160, United States
Tennessee Oncology, PLLC- Skyline
RECRUITING

Nashville, Tennessee, 37207, United States
Tennessee Oncology, PLLC- Smyrna
RECRUITING

Smyrna, Tennessee, 37167, United States
Tennessee Oncology, PLLC- Southern Hills
RECRUITING

Nashville, Tennessee, 37211, United States
Tennessee Oncology, PLLC-Dickson
RECRUITING

Dickson, Tennessee, 37055, United States
Tennessee Oncology, PLLC-Elliston Place Plaza Medical Oncology &Hematology
RECRUITING

Nashville, Tennessee, 37203, United States
Tennessee Oncology, PLLC-Franklin
RECRUITING

Franklin, Tennessee, 37067, United States
Tennessee Oncology, PLLC-Gallatin
RECRUITING

Gallatin, Tennessee, 37066, United States
Tennessee Oncology, PLLC-Hendersonville
RECRUITING

Hendersonville, Tennessee, 37075, United States
Tennessee Oncology, PLLC-Investigational Drug Services
RECRUITING

Nashville, Tennessee, 37203, United States
Tennessee Oncology, PLLC-Lebanon
RECRUITING

Lebanon, Tennessee, 37090, United States
Tennessee Oncology, PLLC-Mount Juliet
RECRUITING

Mount Juliet, Tennessee, 37122, United States
Tennessee Oncology, PLLC-Murfreesboro
RECRUITING

Murfreesboro, Tennessee, 37129, United States
Texas Oncology - Central South
RECRUITING

Austin, Texas, 78705, United States
Texas Oncology - Central South
RECRUITING

Austin, Texas, 78731, United States
Texas Oncology - Central South
RECRUITING

Austin, Texas, 78745, United States
Texas Oncology - Central South
RECRUITING

Austin, Texas, 78758, United States
Texas Oncology - Central South
RECRUITING

Harlingen, Texas, 78550, United States
Texas Oncology - Central South
RECRUITING

McAllen, Texas, 78503, United States
Texas Oncology - Central South
RECRUITING

Waco, Texas, 76712, United States
Texas Oncology - Central South
RECRUITING

Weslaco, Texas, 78596, United States
Texas Oncology - Gulf Coast
RECRUITING

Beaumont, Texas, 77702, United States
Texas Oncology - Gulf Coast
RECRUITING

Houston, Texas, 77024, United States
Texas Oncology - Gulf Coast
RECRUITING

Houston, Texas, 77054, United States
Texas Oncology - Gulf Coast
RECRUITING

Pearland, Texas, 77584, United States
Texas Oncology - Gulf Coast
RECRUITING

Sugar Land, Texas, 77479, United States
Texas Oncology - Gulf Coast
RECRUITING

The Woodlands, Texas, 77380, United States
Texas Oncology - Gulf Coast
RECRUITING

Webster, Texas, 77598, United States
The University of Osaka Hospital
RECRUITING

Suita, Osaka, 565-0871, Japan
The University of Texas, MD Anderson Cancer Center - Conroe
NOT_YET_RECRUITING

Conroe, Texas, 77384, United States
The University of Texas, MD Anderson Cancer Center - League City
NOT_YET_RECRUITING

League City, Texas, 77573, United States
The University of Texas, MD Anderson Cancer Center - Sugar Land
NOT_YET_RECRUITING

Sugar Land, Texas, 77478, United States
The University of Texas, MD Anderson Cancer Center - West Houston
NOT_YET_RECRUITING

Houston, Texas, 77079, United States
The first affiliated hospital of Ningbo university
RECRUITING

Ningbo, Zhejiang, 315010, China
UC Health Lone Tree Medical Center
NOT_YET_RECRUITING

Lone Tree, Colorado, 80124, United States
UC San Diego / Moores Cancer Center
RECRUITING

La Jolla, California, 92037, United States
UC San Diego Koman Family Outpatient Pavilion
RECRUITING

La Jolla, California, 92037, United States
UC San Diego McGrath Outpatient Pavilion - Hillcrest
RECRUITING

San Diego, California, 92103, United States
UC San Diego Medical Center - Bankers Hill
RECRUITING

San Diego, California, 92101, United States
UC San Diego Medical Center - Encinitas
RECRUITING

Encinitas, California, 92024, United States
UC San Diego Medical Center - Hillcrest
RECRUITING

San Diego, California, 92103, United States
UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Pavilion)
RECRUITING

La Jolla, California, 92037, United States
UC San Diego Medical Center - Rancho Bernardo
RECRUITING

San Diego, California, 92127, United States
UC San Diego Medical Center - Vista
RECRUITING

Vista, California, 92081, United States
UC San Diego Sulpizio Cardiovascular Center
RECRUITING

La Jolla, California, 92037, United States
UCHealth Cherry Creek Medical Center
NOT_YET_RECRUITING

Denver, Colorado, 80206, United States
US Oncology Investigational Products Center
RECRUITING

Irving, Texas, 75063, United States
US Oncology Investigational Products Center (IPC)
RECRUITING

Irving, Texas, 75063, United States
UT Southwestern Medical Center
RECRUITING

Dallas, Texas, 75390, United States
Union Hospital Tongji Medical College Huazhong University of Science and Technology
RECRUITING

Wuhan, Hubei, 430022, China
University Of Washington Medical Center
RECRUITING

Seattle, Washington, 98195, United States
University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP)
NOT_YET_RECRUITING

Aurora, Colorado, 80045, United States
University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP)
NOT_YET_RECRUITING

Aurora, Colorado, 80045, United States
University of Colorado Hospital-Anschutz Cancer Pavilion (ACP)
NOT_YET_RECRUITING

Aurora, Colorado, 80045, United States
University of Texas MD Anderson Cancer Center
NOT_YET_RECRUITING

Houston, Texas, 77030, United States
University of Texas Southwestern Medical Center - Simmons Cancer Center
RECRUITING

Dallas, Texas, 75235, United States
University of Texas Southwestern Medical Center-William P. Clements Jr. University Hospital
RECRUITING

Dallas, Texas, 75235, United States
University of Texas Southwestern Medical Center-Zale Lipshy University Hospital
RECRUITING

Dallas, Texas, 75390, United States
University of Texas Southwestern Simmons Cancer Center - Fort Worth
RECRUITING

Fort Worth, Texas, 76104, United States
University of Texas Southwestern Simmons Cancer Center - Redbird
RECRUITING

Dallas, Texas, 75237, United States
University of Texas Southwestern Simmons Cancer Center - Richardson/Plano
RECRUITING

Richardson, Texas, 75080, United States
Universitätsklinikum Carl Gustav Carus an der TU Dresden
RECRUITING

Dresden, Saxony, 01307, Germany
Vall d'Hebron Institute of Oncology (VHIO)
RECRUITING

Barcelona, 08035, Spain
Virginia Cancer Specialists, PC
RECRUITING

Fairfax, Virginia, 22031, United States
Washington University School of Medicine - Siteman Cancer Center
RECRUITING

St Louis, Missouri, 63110, United States
Yamagata University Hospital
RECRUITING

Yamagata, 990-9585, Japan
Yokohama City University Medical Center
RECRUITING

Yokohama, Kanagawa, 232-0024, Japan

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