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

September 14, 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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
224

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Australia
    • Queensland
      • Auchenflower, Queensland, Australia, 4066
        • Recruiting
        • Icon Cancer Centre Wesley
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Recruiting
        • Monash Health
  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100142
        • Recruiting
        • Beijing Cancer Hospital
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 400030
        • Not yet recruiting
        • Chongqing University Cancer Hospital
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Recruiting
        • Union Hospital Tongji Medical College Huazhong University Of Science And Technology
    • Hunan
      • Changsha, Hunan, China, 410013
        • Recruiting
        • Hunan Cancer Hospital
    • Jiangsu
      • Nanjing, Jiangsu, China, 210008
        • Recruiting
        • Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
    • Shandong
      • Jinan, Shandong, China, 250012
        • Recruiting
        • Qilu Hospital of Shandong University
    • Zhejiang
      • Ningbo, Zhejiang, China, 315010
        • Recruiting
        • The First Affiliated Hospital of Ningbo University
  • Germany
      • Berlin, Germany, 10117
        • Not yet recruiting
        • Charite Universitaetsmedizin Berlin
    • Saxony
      • Dresden, Saxony, Germany, 01307
        • Recruiting
        • Universitatsklinikum Carl Gustav Carus an der TU Dresden
  • 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
      • Barcelona, Spain, 08035
        • Recruiting
        • Vall d'Hebron Institute of Oncology (VHIO)
      • Madrid, Spain, 28041
        • Recruiting
        • Hospital Universitario 12 de Octubre
      • Madrid, Spain, 28040
        • Recruiting
        • Hospital Clinico San Carlos
      • Madrid, Spain, 28040
        • Recruiting
        • Hospital Universitario Fundación Jiménez Díaz
    • Catalunya [cataluña]
      • Barcelona, Catalunya [cataluña], Spain, 08041
        • Recruiting
        • Hospital de La Santa Creu i Sant Pau
    • Málaga
      • Málaga, Málaga, Spain, 29010
        • Recruiting
        • Hospital Universitario Virgen de la Victoria
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Recruiting
        • Mayo Clinic Building- Phoenix
      • Scottsdale, Arizona, United States, 85259
        • Recruiting
        • Mayo Clinic Arizona
    • 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, PA
    • 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
        • Recruiting
        • UC San Diego Medical Center - Encinitas
      • Irvine, California, United States, 92618
        • Recruiting
        • City of Hope at Irvine Lennar
      • Irvine, California, United States, 92618
        • Recruiting
        • City of Hope Investigational Drug Services (IDS)
      • La Jolla, California, United States, 92037
        • Recruiting
        • UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Pavilion)
      • La Jolla, California, United States, 92037
        • Recruiting
        • UC San Diego Sulpizio Cardiovascular Center
      • La Jolla, California, United States, 92037
        • Recruiting
        • UC San Diego / Moores Cancer Center
      • La Jolla, California, United States, 92037
        • Recruiting
        • UC San Diego Koman Family Outpatient Pavilion
      • Long Beach, California, United States, 90813
        • Recruiting
        • City of Hope
      • San Diego, California, United States, 92103
        • Recruiting
        • UC San Diego Medical Center - Hillcrest
      • San Diego, California, United States, 92101
        • Recruiting
        • UC San Diego Medical Center - Bankers Hill
      • San Diego, California, United States, 92103
        • Recruiting
        • UC San Diego McGrath Outpatient Pavilion - Hillcrest
      • San Diego, California, United States, 92127
        • Recruiting
        • UC San Diego Medical Center - Rancho Bernardo
      • Upland, California, United States, 91786
        • Recruiting
        • City of Hope Upland
      • Vista, California, United States, 92081
        • Recruiting
        • UC San Diego Medical Center - Vista
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Not yet recruiting
        • University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP)
      • Aurora, Colorado, United States, 80045
        • Not yet recruiting
        • University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP)
      • Aurora, Colorado, United States, 80012
        • Recruiting
        • Rocky Mountain Cancer Centers,LLP
      • Aurora, Colorado, United States, 80045
        • Not yet recruiting
        • Clinical and Translational Research Center(CTRC)
      • Aurora, Colorado, United States, 80045
        • Not yet recruiting
        • University of Colorado Hospital-Anschutz Cancer Pavilion (ACP)
      • Denver, Colorado, United States, 80218
        • Recruiting
        • Rocky Mountain Cancer Centers,LLP
      • Denver, Colorado, United States, 80206
        • Not yet recruiting
        • UCHealth Cherry Creek Medical Center
      • Highlands Ranch, Colorado, United States, 80129
        • Not yet recruiting
        • Highlands Ranch Hospital
      • Lakewood, Colorado, United States, 80228
        • Recruiting
        • Rocky Mountain Cancer Centers, LLP
      • Lone Tree, Colorado, United States, 80124
        • Recruiting
        • Rocky Mountain Cancer Centers,LLP
      • Lone Tree, Colorado, United States, 80124
        • Not yet recruiting
        • UC Health Lone Tree Medical Center
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Recruiting
        • Mayo Clinic Pharmacy
      • Orlando, Florida, United States, 32806
        • Recruiting
        • Orlando Health Cancer Institute
      • Orlando, Florida, United States, 32806
        • Recruiting
        • Orlando Health Orlando Regional Medical Center
      • Orlando, Florida, United States, 32806
        • Recruiting
        • Orlando Health Ambulatory Care Center
    • Georgia
      • Ringgold, Georgia, United States, 30736
        • Recruiting
        • Tennessee Oncology, PLLC- Ringgold
    • Illinois
      • Shiloh, Illinois, United States, 62269
        • Recruiting
        • Siteman Cancer Center - Shiloh
      • Shiloh, Illinois, United States, 62269
        • Recruiting
        • Memorial Hospital
      • Zion, Illinois, United States, 60099
        • Recruiting
        • City Of Hope - Chicago
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Brigham and Women's Hospital
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Dana Farber/Mass General Brigham Cancer Care, Inc
      • Newton, Massachusetts, United States, 02467
        • 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
        • Recruiting
        • Mayo Clinic Cancer Center Outpatient Pharmacy
      • Rochester, Minnesota, United States, 55902
        • Recruiting
        • Mayo Clinic Hospital, Methodist Campus, Research Pharmacy
      • Woodbury, Minnesota, United States, 55125
        • Recruiting
        • Minnesota Oncology Hematology, P.A.
    • Missouri
      • City of Saint Peters, Missouri, United States, 63376
        • Recruiting
        • Siteman Cancer Center - St. Peters
      • Creve Coeur, Missouri, United States, 63141
        • Recruiting
        • Siteman Cancer Center - West County
      • Florissant, Missouri, United States, 63031
        • Recruiting
        • Siteman Cancer Center - North County
      • St Louis, Missouri, United States, 63108
        • Recruiting
        • Siteman Cancer Center
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine - Siteman Cancer Center
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Barnes-Jewish Hospital
      • St Louis, Missouri, United States, 63129
        • Recruiting
        • Siteman Cancer Center - South County
    • 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, 10029
        • Recruiting
        • Icahn School of Medicine at Mount Sinai
      • 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
    • Oregon
      • Portland, Oregon, United States, 97227
        • Recruiting
        • Northwest Cancer Specialists, P.C.
    • 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
        • Recruiting
        • Tennessee Oncology, PLLC - Chattanooga Med Park II
      • Chattanooga, Tennessee, United States, 37404
        • Recruiting
        • Tennessee Oncology, PLLC - Chattanooga Memorial
      • Chattanooga, Tennessee, United States, 37403
        • Recruiting
        • Tennessee Oncology, PLLC- Chattanooga Downtown
      • Chattanooga, Tennessee, United States, 37404
        • Recruiting
        • Tennessee Oncology, PLLC - Investigational Drug Services/Supply Storage
      • Chattanooga, Tennessee, United States, 37421
        • Recruiting
        • Tennessee Oncology, PLLC- Chattanooga East
      • Cookeville, Tennessee, United States, 38501
        • Recruiting
        • Tennessee Oncology, PLLC- Cookeville
      • Dickson, Tennessee, United States, 37055
        • Recruiting
        • Tennessee Oncology, PLLC-Dickson
      • Franklin, Tennessee, United States, 37067
        • Recruiting
        • Tennessee Oncology, PLLC- Franklin Proton Center
      • Franklin, Tennessee, United States, 37067
        • Recruiting
        • Tennessee Oncology, PLLC-Franklin
      • Gallatin, Tennessee, United States, 37066
        • Recruiting
        • Tennessee Oncology, PLLC-Gallatin
      • Hendersonville, Tennessee, United States, 37075
        • Recruiting
        • Tennessee Oncology, PLLC-Hendersonville
      • Lebanon, Tennessee, United States, 37090
        • Recruiting
        • Tennessee Oncology, PLLC-Lebanon
      • Mount Juliet, Tennessee, United States, 37122
        • Recruiting
        • Tennessee Oncology, PLLC-Mount Juliet
      • Murfreesboro, Tennessee, United States, 37129
        • Recruiting
        • Tennessee Oncology, PLLC-Murfreesboro
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Sarah Cannon Research Institute
      • Nashville, Tennessee, United States, 37232
        • Not yet recruiting
        • Henry-Joyce Cancer Clinic
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • SCRI Oncology Partners
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Tennessee Oncology, PLLC-Elliston Place Plaza Medical Oncology &Hematology
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Tennessee Oncology, PLLC- Elliston Place Plaza
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Tennessee Oncology, PLLC-Investigational Drug Services
      • Nashville, Tennessee, United States, 37205
        • Recruiting
        • Tennessee Oncology, PLLC- Saint Thomas West
      • Nashville, Tennessee, United States, 37207
        • Recruiting
        • Tennessee Oncology, PLLC- Skyline
      • Nashville, Tennessee, United States, 37211
        • Recruiting
        • Tennessee Oncology, PLLC- Southern Hills
      • Shelbyville, Tennessee, United States, 37160
        • Recruiting
        • Tennessee Oncology, PLLC- Shelbyville
      • Smyrna, Tennessee, United States, 37167
        • 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
      • Conroe, Texas, United States, 77384
        • Not yet recruiting
        • The University of Texas, MD Anderson Cancer Center - Conroe
      • Dallas, Texas, United States, 75390
        • Recruiting
        • UT Southwestern Medical Center
      • Dallas, Texas, United States, 75390
        • Recruiting
        • University of Texas Southwestern Medical Center-Zale Lipshy University Hospital
      • Dallas, Texas, United States, 75235
        • Recruiting
        • University of Texas Southwestern Medical Center - Simmons Cancer Center
      • Dallas, Texas, United States, 75237
        • Recruiting
        • University of Texas Southwestern Simmons Cancer Center - Redbird
      • Dallas, Texas, United States, 75235
        • Recruiting
        • University of Texas Southwestern Medical Center-William P. Clements Jr. University Hospital
      • Fort Worth, Texas, United States, 76104
        • Recruiting
        • University of Texas Southwestern Simmons Cancer Center - Fort Worth
      • Harlingen, Texas, United States, 78550
        • Recruiting
        • Texas Oncology - Central South
      • Houston, Texas, United States, 77030
        • Not yet recruiting
        • University of Texas MD Anderson Cancer Center
      • Houston, Texas, United States, 77024
        • Recruiting
        • Texas Oncology - Gulf Coast
      • Houston, Texas, United States, 77079
        • Not yet recruiting
        • The University of Texas, MD Anderson Cancer Center - West Houston
      • 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
      • League City, Texas, United States, 77573
        • Not yet recruiting
        • The University of Texas, MD Anderson Cancer Center - League City
      • McAllen, Texas, United States, 78503
        • Recruiting
        • Texas Oncology - Central South
      • Pearland, Texas, United States, 77584
        • Recruiting
        • Texas Oncology - Gulf Coast
      • Richardson, Texas, United States, 75080
        • Recruiting
        • University of Texas Southwestern Simmons Cancer Center - Richardson/Plano
      • Sugar Land, Texas, United States, 77479
        • Recruiting
        • Texas Oncology - Gulf Coast
      • Sugar Land, Texas, United States, 77478
        • Not yet recruiting
        • The University of Texas, MD Anderson Cancer Center - Sugar Land
      • 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
      • Seattle, Washington, United States, 98195
        • Recruiting
        • University of Washington Medical Center
      • Seattle, Washington, United States, 98109
        • Recruiting
        • Fred Hutchinson Cancer Center
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Experimental: Cohort D
Participants will receive PF-08634404 in combination with Casdatifan.
Drug: PF-08634404
Concentrate for solution for infusion
Other Names:
  • SSGJ-707
Drug: Casdatifan
Tablet

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pfizer

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 10, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 2, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 7, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 7, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 12, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 14, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • C6461008
  • 2025 (U.S. NIH Grant/Contract: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
  • 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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