Symbiotic-GU-08: A Study to Learn About the Medicine Called PF-08634404 Dosed Alone and in Combination With Other Anticancer Therapies in Adults With Locally Advanced or Metastatic Renal Cell Cancer

June 3, 2026 updated by: Pfizer

AN INTERVENTIONAL PHASE 1B/2 STUDY TO EVALUATE THE SAFETY AND EFFICACY OF PF-08634404 MONOTHERAPY AND IN COMBINATION WITH OTHER ANTICANCER AGENTS IN ADULT PARTICIPANTS WITH LOCALLY ADVANCED OR METASTATIC RENAL CELL CARCINOMA

This study is testing a new medicine called PF-08634404 and how it works in adults with advanced Renal Cell Carcinoma (RCC)- a type of kidney cancer that is either locally advanced (spread to nearby tissues) or metastatic (spread to other parts of the body). The study will look at the safety of the study medicine, when given alone or with other anticancer medicines, and how this type of cancer responds to them.

To join the study, participants must be adults; with locally advanced or metastatic RCC; who have not received treatment for their advanced kidney cancer.

Participants will receive study medicine either alone or with other anticancer medicines. The medicine will be given through intravenous (IV) infusions, which means it will be injected directly into a vein. All treatments will take place at clinical study sites, where trained medical staff will take care of participants during and after each visit.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

224

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

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

Study Contact

Study Locations

  • Australia
    • Queensland
      • Auchenflower, Queensland, Australia, 4066
        • Recruiting
        • Icon Cancer Centre Wesley
  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100142
        • Not yet recruiting
        • Beijing Cancer Hospital
  • Japan
      • Fukuoka, Japan, 811-1395
        • Recruiting
        • National Hospital Organization Kyushu Cancer Center
      • Yamagata, Japan, 990-9585
        • Recruiting
        • Yamagata University Hospital
    • Kanagawa
      • Yokohama, Kanagawa, Japan, 232-0024
        • Recruiting
        • Yokohama City University Medical Center
    • Osaka
      • Suita, Osaka, Japan, 565-0871
        • Recruiting
        • The University of Osaka Hospital
    • Tokyo
      • Shinjuku-ku, Tokyo, Japan, 1608582
        • Recruiting
        • Keio University Hospital
  • Spain
      • Madrid, Spain, 28041
        • Not yet recruiting
        • Hospital Universitario 12 de octubre
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Not yet recruiting
        • Mayo Clinic Building- Phoenix
      • Scottsdale, Arizona, United States, 85259
        • Not yet recruiting
        • Mayo Clinic
    • Arkansas
      • Fayetteville, Arkansas, United States, 72703
        • Recruiting
        • Highlands Oncology Group
      • Rogers, Arkansas, United States, 72758
        • Recruiting
        • Highlands Oncology Group
      • Springdale, Arkansas, United States, 72762
        • Recruiting
        • Highlands Oncology Group
    • California
      • Duarte, California, United States, 91010
        • Recruiting
        • City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
      • Duarte, California, United States, 91010
        • Recruiting
        • City of Hope Investigational Drug Services (IDS)
      • Encinitas, California, United States, 92024
        • Not yet recruiting
        • UC San Diego Medical Center - Encinitas
      • Irvine, California, United States, 92618
        • Recruiting
        • City of Hope
      • Irvine, California, United States, 92618
        • Recruiting
        • City of Hope Investigational Drug Services (IDS)
      • La Jolla, California, United States, 92037
        • Not yet recruiting
        • UC San Diego / Moores Cancer Center
      • La Jolla, California, United States, 92037
        • Not yet recruiting
        • UC San Diego Koman Family Outpatient Pavilion
      • La Jolla, California, United States, 92037
        • Not yet recruiting
        • UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Pavilion)
      • La Jolla, California, United States, 92037
        • Not yet recruiting
        • UC San Diego Sulpizio Cardiovascular Center
      • Long Beach, California, United States, 90813
        • Recruiting
        • City of Hope
      • San Diego, California, United States, 92103
        • Not yet recruiting
        • UC San Diego Medical Center - Hillcrest
      • San Diego, California, United States, 92101
        • Not yet recruiting
        • UC San Diego Medical Center - Bankers Hill
      • San Diego, California, United States, 92103
        • Not yet recruiting
        • UC San Diego McGrath Outpatient Pavilion - Hillcrest
      • San Diego, California, United States, 92127
        • Not yet recruiting
        • UC San Diego Medical Center - Rancho Bernardo
      • Upland, California, United States, 91786
        • Recruiting
        • City of Hope UPLAND
      • Vista, California, United States, 92081
        • Not yet recruiting
        • UC San Diego Medical Center - Vista
    • Colorado
      • Denver, Colorado, United States, 80218
        • Recruiting
        • Rocky Mountain Cancer Centers, LLP
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Not yet recruiting
        • Mayo Clinic Pharmacy
    • Georgia
      • Ringgold, Georgia, United States, 30736
        • Not yet recruiting
        • Tennessee Oncology, PLLC- Ringgold
    • Illinois
      • Zion, Illinois, United States, 60099
        • Recruiting
        • City Of Hope - Chicago
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Not yet recruiting
        • Dana-Farber Cancer Institute
      • Boston, Massachusetts, United States, 02115
        • Not yet recruiting
        • Brigham and Women's Hospital
      • Newton, Massachusetts, United States, 02467
        • Not yet recruiting
        • Dana-Farber Cancer Institute - Chestnut Hill
    • Minnesota
      • Burnsville, Minnesota, United States, 55337
        • Recruiting
        • Minnesota Oncology Hematology, P.A.
      • Chaska, Minnesota, United States, 55318
        • Recruiting
        • Minnesota Oncology Hematology, P.A.
      • Coon Rapids, Minnesota, United States, 55433
        • Recruiting
        • Minnesota Oncology Hematology, P.A.
      • Edina, Minnesota, United States, 55435
        • Recruiting
        • Minnesota Oncology Hematology, P.A.
      • Maple Grove, Minnesota, United States, 55369
        • Recruiting
        • Minnesota Oncology Hematology, P.A.
      • Maplewood, Minnesota, United States, 55109
        • Recruiting
        • Minnesota Oncology Hematology, P.A.
      • Rochester, Minnesota, United States, 55905
        • Not yet recruiting
        • Mayo Clinic Cancer Center Outpatient Pharmacy
      • Rochester, Minnesota, United States, 55902
        • Not yet recruiting
        • Mayo Clinic Hospital, Methodist Campus, Research Pharmacy
      • Woodbury, Minnesota, United States, 55125
        • Recruiting
        • Minnesota Oncology Hematology, P.A.
    • New Jersey
      • Basking Ridge, New Jersey, United States, 07920
        • Recruiting
        • MSK Basking Ridge
      • Middletown, New Jersey, United States, 07748
        • Recruiting
        • MSK Monmouth
      • Montvale, New Jersey, United States, 07645
        • Recruiting
        • MSK Bergen
    • New York
      • Albany, New York, United States, 12206
        • Recruiting
        • New York Oncology Hematology, P.C.
      • Clifton Park, New York, United States, 12065
        • Recruiting
        • New York Oncology Hematology - Clifton Park Cancer Center
      • Commack, New York, United States, 11725
        • Recruiting
        • MSK Commack
      • Harrison, New York, United States, 10604
        • Recruiting
        • MSK Westchester
      • Long Island City, New York, United States, 11101
        • Recruiting
        • Memorial Sloan Kettering Cancer Center - Investigational Drug Service Pharmacy
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center - Main Campus
      • New York, New York, United States, 10065
        • Recruiting
        • Sidney Kimmel Center for Prostate and Urological Cancers - Memorial Sloan Kettering Cancer Center
      • New York, New York, United States, 10065
        • Recruiting
        • Evelyn H. Lauder Breast and Imaging Center (BAIC)
      • Uniondale, New York, United States, 11553
        • Recruiting
        • MSK Nassau
    • South Carolina
      • Myrtle Beach, South Carolina, United States, 29572
        • Recruiting
        • Carolina Urologic Research Center, LLC
      • Myrtle Beach, South Carolina, United States, 29572
        • Recruiting
        • Parkway Surgery Center
      • Myrtle Beach, South Carolina, United States, 295724607
        • Recruiting
        • Grand Strand Medical Center
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Not yet recruiting
        • Tennessee Oncology, PLLC - Chattanooga Med Park II
      • Chattanooga, Tennessee, United States, 37404
        • Not yet recruiting
        • Tennessee Oncology, PLLC - Chattanooga Memorial
      • Chattanooga, Tennessee, United States, 37404
        • Not yet recruiting
        • Tennessee Oncology, PLLC - Investigational Drug Services/Supply Storage
      • Chattanooga, Tennessee, United States, 37403
        • Not yet recruiting
        • Tennessee Oncology, PLLC- Chattanooga Downtown
      • Chattanooga, Tennessee, United States, 37421
        • Not yet recruiting
        • Tennessee Oncology, PLLC- Chattanooga East
      • Cookeville, Tennessee, United States, 38501
        • Not yet recruiting
        • Tennessee Oncology, PLLC- Cookeville
      • Dickson, Tennessee, United States, 37055
        • Not yet recruiting
        • Tennessee Oncology, PLLC-Dickson
      • Franklin, Tennessee, United States, 37067
        • Not yet recruiting
        • Tennessee Oncology, PLLC- Franklin Proton Center
      • Franklin, Tennessee, United States, 37067
        • Not yet recruiting
        • Tennessee Oncology, PLLC-Franklin
      • Gallatin, Tennessee, United States, 37066
        • Not yet recruiting
        • Tennessee Oncology, PLLC-Gallatin
      • Hendersonville, Tennessee, United States, 37075
        • Not yet recruiting
        • Tennessee Oncology, PLLC-Hendersonville
      • Lebanon, Tennessee, United States, 37090
        • Not yet recruiting
        • Tennessee Oncology, PLLC-Lebanon
      • Mount Juliet, Tennessee, United States, 37122
        • Not yet recruiting
        • Tennessee Oncology, PLLC-Mount Juliet
      • Murfreesboro, Tennessee, United States, 37129
        • Not yet recruiting
        • Tennessee Oncology, PLLC-Murfreesboro
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Sarah Cannon Research Institute
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • SCRI Oncology Partners
      • Nashville, Tennessee, United States, 37203
        • Not yet recruiting
        • Tennessee Oncology, PLLC- Elliston Place Plaza
      • Nashville, Tennessee, United States, 37203
        • Not yet recruiting
        • Tennessee Oncology, PLLC-Elliston Place Plaza Medical Oncology &Hematology
      • Nashville, Tennessee, United States, 37203
        • Not yet recruiting
        • Tennessee Oncology, PLLC-Investigational Drug Services
      • Nashville, Tennessee, United States, 37205
        • Not yet recruiting
        • Tennessee Oncology, PLLC- Saint Thomas West
      • Nashville, Tennessee, United States, 37207
        • Not yet recruiting
        • Tennessee Oncology, PLLC- Skyline
      • Nashville, Tennessee, United States, 37211
        • Not yet recruiting
        • Tennessee Oncology, PLLC- Southern Hills
      • Shelbyville, Tennessee, United States, 37160
        • Not yet recruiting
        • Tennessee Oncology, PLLC- Shelbyville
      • Smyrna, Tennessee, United States, 37167
        • Not yet recruiting
        • Tennessee Oncology, PLLC- Smyrna
    • Texas
      • Austin, Texas, United States, 78731
        • Recruiting
        • Texas Oncology - Central South
      • Austin, Texas, United States, 78758
        • Recruiting
        • Texas Oncology - Central South
      • Austin, Texas, United States, 78705
        • Recruiting
        • Texas Oncology - Central South
      • Austin, Texas, United States, 78745
        • Recruiting
        • Texas Oncology - Central South
      • Beaumont, Texas, United States, 77702
        • Recruiting
        • Texas Oncology - Gulf Coast
      • Harlingen, Texas, United States, 78550
        • Recruiting
        • Texas Oncology - Central South
      • Houston, Texas, United States, 77024
        • Recruiting
        • Texas Oncology - Gulf Coast
      • Houston, Texas, United States, 77054
        • Recruiting
        • Texas Oncology - Gulf Coast
      • Irving, Texas, United States, 75063
        • Recruiting
        • US Oncology Investigational Products Center (IPC)
      • Irving, Texas, United States, 75063
        • Recruiting
        • US Oncology Investigational Products Center
      • McAllen, Texas, United States, 78503
        • Recruiting
        • Texas Oncology - Central South
      • Pearland, Texas, United States, 77584
        • Recruiting
        • Texas Oncology - Gulf Coast
      • Sugar Land, Texas, United States, 77479
        • Recruiting
        • Texas Oncology - Gulf Coast
      • The Woodlands, Texas, United States, 77380
        • Recruiting
        • Texas Oncology - Gulf Coast
      • Waco, Texas, United States, 76712
        • Recruiting
        • Texas Oncology - Central South
      • Webster, Texas, United States, 77598
        • Recruiting
        • Texas Oncology - Gulf Coast
      • Weslaco, Texas, United States, 78596
        • Recruiting
        • Texas Oncology - Central South
    • Virginia
      • Blacksburg, Virginia, United States, 24060
        • Recruiting
        • Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
      • Fairfax, Virginia, United States, 22031
        • Recruiting
        • Virginia Cancer Specialists, PC
      • Low Moor, Virginia, United States, 24457
        • Recruiting
        • Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
      • Roanoke, Virginia, United States, 24014
        • Recruiting
        • Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
      • Salem, Virginia, United States, 24153
        • Recruiting
        • Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
      • Wytheville, Virginia, United States, 24382
        • Recruiting
        • Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
    • Washington
      • Vancouver, Washington, United States, 98684
        • Recruiting
        • Northwest Cancer Specialists, P.C.
    • Wisconsin
      • Hudson, Wisconsin, United States, 54016
        • Recruiting
        • Minnesota Oncology Hematology, P.A.

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort A
Participants will receive PF-08634404 IV.
Drug: PF-08634404
Concentrate for solution for infusion
Other Names:
  • SSGJ-707
Experimental: Cohort B
Participants will receive PF-08634404 in combination with ipilimumab.
Drug: Ipilimumab
Solution for infusion
Other Names:
  • yervoy
Drug: PF-08634404
Concentrate for solution for infusion
Other Names:
  • SSGJ-707
Experimental: Cohort C
Participants will receive PF-08634404 IV in combination with axitinib.
Drug: PF-08634404
Concentrate for solution for infusion
Other Names:
  • SSGJ-707
Drug: Axitinib
Tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Confirmed objective response rate (ORR) using RECIST v1.1 as assessed by investigator
Time Frame: Up to approximately 3 years
ORR is defined as the proportion of participants in the analysis population having a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST v1.1 as assessed by investigator.
Up to approximately 3 years
Number of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: Through 90 days after the last study intervention (Up to approximately 3 years)
AEs as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study intervention.
Through 90 days after the last study intervention (Up to approximately 3 years)
Number of participants with dose limiting toxicity (DLT)
Time Frame: Though end of DLT evaluation period (Up to approximately 3 years)
The number of participants who experienced DLTs during the DLT evaluation period in Cohort B (combination 1) and Cohort C (combination 2).
Though end of DLT evaluation period (Up to approximately 3 years)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of Response (DOR) per RECIST v1.1 by investigator
Time Frame: Up to approximately 3 years
DOR is defined as the time from the first documentation of objective response (CR or PR that is subsequently confirmed) to the date of first documented disease progression per RECIST v1.1 or death due to any cause, whichever occurs first.
Up to approximately 3 years
Progression Free Survival (PFS) per RECIST v1.1 by investigator
Time Frame: Up to approximately 3 years
Progression-free survival is defined as the time from the date of randomization to the date of the first documentation of objective progressive disease (PD) assessed by investigator per RECIST v1.1, or death due to any cause, whichever occurs first.
Up to approximately 3 years
Overall Survival (OS)
Time Frame: Up to approximately 3 years
Overall survival defined as the time from the date of randomization to the date of death due to any cause.
Up to approximately 3 years
Number of Participants With Clinical Laboratory Abnormalities
Time Frame: Time from the date of first dose of study intervention through 30-37 days after last dose of study intervention (approximately 3 years)
laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0) and timing
Time from the date of first dose of study intervention through 30-37 days after last dose of study intervention (approximately 3 years)
Pharmacokinetics (PK): Serum concentration of PF-08634404
Time Frame: Up to 37 days after the last dose of treatment
Pre-dose and post dose concentrations of PF-08634404
Up to 37 days after the last dose of treatment
Incidence of Anti-Drug Antibody (ADA) against PF-08634404
Time Frame: Up to 37 days after the last dose of treatment
To evaluate the immunogenicity of PF-08634404
Up to 37 days after the last dose of treatment

Collaborators and Investigators

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

Sponsor

Pfizer

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

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

Helpful Links

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 Major Dates

Study Start (Actual)

February 10, 2026

Primary Completion (Estimated)

November 2, 2027

Study Completion (Estimated)

November 1, 2028

Study Registration Dates

First Submitted

November 7, 2025

First Submitted That Met QC Criteria

November 7, 2025

First Posted (Actual)

November 12, 2025

Study Record Updates

Last Update Posted (Actual)

June 4, 2026

Last Update Submitted That Met QC Criteria

June 3, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C6461008
  • 2025-523524-53-00 (Ctis)
  • Symbiotic-GU-08 (Other Identifier: Pfizer)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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