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

Last updated: April 17, 2026
Sponsor: Pfizer
Overall Status: Active - Recruiting

Phase

1/2

Condition

Kidney Cancer

Renal Cell Carcinoma

Renal Cancer

Treatment

Combination 2

Combination 1

PF-08634404

Clinical Study ID

NCT07227415
C6461008
Symbiotic-GU-08
2025-523524-53-00
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 18 years of age or older at screening

  • Locally advanced (not amenable to curative surgery or radiation therapy) ormetastatic 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 ifreceived >12 months prior)

  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.

  • All International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) basedrisk categories

Exclusion

Exclusion Criteria:

Participants may be excluded if they meet any of the following:

  • Known active brain lesions including leptomeningeal metastasis, brainstem, meningealor 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 celltransplantation.

  • 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 plannedmajor 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

  • Acute, chronic or symptomatic infections

  • Participants with history of immunodeficiency

Study Design

Total Participants: 224
Treatment Group(s): 3
Primary Treatment: Combination 2
Phase: 1/2
Study Start date:
March 12, 2026
Estimated Completion Date:
November 01, 2028

Connect with a study center

  • Icon Cancer Centre Wesley

    Auchenflower, Queensland 4066
    Australia

    Active - Recruiting

  • Icon Cancer Centre Wesley

    Auchenflower 6943571, Queensland 2152274 4066
    Australia

    Site Not Available

  • The University of Osaka Hospital

    Suita, Osaka 565-0871
    Japan

    Site Not Available

  • Keio university hospital

    Shinjuku-ku, Tokyo 1608582
    Japan

    Active - Recruiting

  • National Hospital Organization Kyushu Cancer Center

    Fukuoka, 811-1395
    Japan

    Active - Recruiting

  • National Hospital Organization Kyushu Cancer Center

    Fukuoka 1863967, 811-1395
    Japan

    Site Not Available

  • Yamagata University Hospital

    Yamagata, 990-9585
    Japan

    Active - Recruiting

  • Yamagata University Hospital

    Yamagata 2110556, 990-9585
    Japan

    Site Not Available

  • Highlands Oncology Group

    Fayetteville, Arkansas 72703
    United States

    Active - Recruiting

  • Highlands Oncology Group

    Rogers, Arkansas 72758
    United States

    Active - Recruiting

  • Highlands Oncology Group

    Springdale, Arkansas 72762
    United States

    Active - Recruiting

  • Highlands Oncology Group

    Springdale 4132093, Arkansas 4099753 72762
    United States

    Site Not Available

  • City of Hope (City of Hope National Medical Center, City of Hope Medical Center)

    Duarte, California 91010
    United States

    Active - Recruiting

  • City of Hope Investigational Drug Services (IDS)

    Duarte, California 91010
    United States

    Active - Recruiting

  • City of Hope

    Irvine, California 92618
    United States

    Active - Recruiting

  • City of Hope Investigational Drug Services (IDS)

    Irvine, California 92618
    United States

    Active - Recruiting

  • City of Hope

    Long Beach, California 90813
    United States

    Active - Recruiting

  • City of Hope UPLAND

    Upland, California 91786
    United States

    Active - Recruiting

  • City of Hope (City of Hope National Medical Center, City of Hope Medical Center)

    Duarte 5344147, California 5332921 91010
    United States

    Site Not Available

  • Rocky Mountain Cancer Centers, LLP

    Denver, Colorado 80218
    United States

    Active - Recruiting

  • Rocky Mountain Cancer Centers, LLP

    Denver 5419384, Colorado 5417618 80218
    United States

    Site Not Available

  • City Of Hope - Chicago

    Zion, Illinois 60099
    United States

    Active - Recruiting

  • City Of Hope - Chicago

    Zion 4917358, Illinois 4896861 60099
    United States

    Site Not Available

  • Minnesota Oncology Hematology, P.A.

    Burnsville, Minnesota 55337
    United States

    Active - Recruiting

  • Minnesota Oncology Hematology, P.A.

    Chaska, Minnesota 55318
    United States

    Active - Recruiting

  • Minnesota Oncology Hematology, P.A.

    Coon Rapids, Minnesota 55433
    United States

    Active - Recruiting

  • Minnesota Oncology Hematology, P.A.

    Edina, Minnesota 55435
    United States

    Active - Recruiting

  • Minnesota Oncology Hematology, P.A.

    Maple Grove, Minnesota 55369
    United States

    Active - Recruiting

  • Minnesota Oncology Hematology, P.A.

    Maplewood, Minnesota 55109
    United States

    Active - Recruiting

  • Minnesota Oncology Hematology, P.A.

    Minneapolis, Minnesota 55404
    United States

    Site Not Available

  • Minnesota Oncology Hematology, P.A.

    Woodbury, Minnesota 55125
    United States

    Active - Recruiting

  • Minnesota Oncology Hematology, P.A.

    Minneapolis 5037649, Minnesota 5037779 55404
    United States

    Site Not Available

  • New York Oncology Hematology, P.C.

    Albany, New York 12206
    United States

    Site Not Available

  • New York Oncology Hematology - Clifton Park Cancer Center

    Clifton Park, New York 12065
    United States

    Site Not Available

  • Carolina Urologic Research Center, LLC

    Myrtle Beach, South Carolina 29572
    United States

    Active - Recruiting

  • Grand Strand Medical Center

    Myrtle Beach, South Carolina 295724607
    United States

    Active - Recruiting

  • Parkway Surgery Center

    Myrtle Beach, South Carolina 29572
    United States

    Active - Recruiting

  • Carolina Urologic Research Center, LLC

    Myrtle Beach 4588718, South Carolina 4597040 29572
    United States

    Site Not Available

  • SCRI Oncology Partners

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • Sarah Cannon Research Institute

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • SCRI Oncology Partners

    Nashville 4644585, Tennessee 4662168 37203
    United States

    Site Not Available

  • Texas Oncology - Central South

    Austin, Texas 78758
    United States

    Active - Recruiting

  • Texas Oncology - Gulf Coast

    Beaumont, Texas 77702
    United States

    Active - Recruiting

  • Texas Oncology - Gulf Coast

    Houston, Texas 77024
    United States

    Active - Recruiting

  • US Oncology Investigational Products Center

    Irving, Texas 75063
    United States

    Active - Recruiting

  • US Oncology Investigational Products Center (IPC)

    Irving, Texas 75063
    United States

    Active - Recruiting

  • Texas Oncology - Central South

    McAllen, Texas 78503
    United States

    Active - Recruiting

  • Texas Oncology - Gulf Coast

    Pearland, Texas 77584
    United States

    Active - Recruiting

  • Texas Oncology - Gulf Coast

    Sugar Land, Texas 77479
    United States

    Active - Recruiting

  • Texas Oncology - Gulf Coast

    The Woodlands, Texas 77380
    United States

    Active - Recruiting

  • Texas Oncology - Gulf Coast

    Webster, Texas 77598
    United States

    Active - Recruiting

  • Texas Oncology - Central South

    Austin 4671654, Texas 4736286 78758
    United States

    Site Not Available

  • Texas Oncology - Gulf Coast

    Houston 4699066, Texas 4736286 77054
    United States

    Site Not Available

  • Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care

    Blacksburg, Virginia 24060
    United States

    Active - Recruiting

  • Virginia Cancer Specialists, PC

    Fairfax, Virginia 22031
    United States

    Active - Recruiting

  • Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care

    Low Moor, Virginia 24457
    United States

    Active - Recruiting

  • Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care

    Roanoke, Virginia 24014
    United States

    Active - Recruiting

  • Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care

    Salem, Virginia 24153
    United States

    Active - Recruiting

  • Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care

    Wytheville, Virginia 24382
    United States

    Active - Recruiting

  • Virginia Cancer Specialists, PC

    Fairfax 4758023, Virginia 6254928 22031
    United States

    Site Not Available

  • Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care

    Wytheville 4794837, Virginia 6254928 24382
    United States

    Site Not Available

  • Minnesota Oncology Hematology, P.A.

    Hudson, Wisconsin 54016
    United States

    Active - Recruiting

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