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

NCT07227415 | Recruiting Phase 1 FDA Drug

• 3 other identifiers: C64610082025-523524-53-00Symbiotic-GU-08
• Study Type: interventional
• Target: 224
• Locations: 3 countries
• Sites: 49

Brief 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.

Conditions

Advanced Renal Cell Carcinoma; Renal Cancer; Renal Neoplasm; Carcinoma, Renal Cell Metastasis; Metastatic Renal Cell Carcinoma; Clear-cell Metastatic Renal Cell Carcinoma; Advanced or Metastatic Renal Cell Carcinoma; Carcinoma, Renal Cell, Advanced; Metastatic Renal Cell Carcinoma ( mRCC); Carcinoma, Renal Cell; Clear Cell Renal Cell Carcinoma; Metastatic Renal Cell Cancer; Metastatic/Advanced Renal Cell Carcinoma

Keywords

Renal cell carcinoma; renal cancer; renal neoplasm

Outcome Measures

Primary Outcomes (3)

• Confirmed objective response rate (ORR) using RECIST v1.1 as assessed by investigator

  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)

  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)

  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 Outcomes (6)

• Duration of Response (DOR) per RECIST v1.1 by investigator

  Up to approximately 3 years

• Progression Free Survival (PFS) per RECIST v1.1 by investigator

  Up to approximately 3 years

• Overall Survival (OS)

  Up to approximately 3 years

• Number of Participants With Clinical Laboratory Abnormalities

  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

  Up to 37 days after the last dose of treatment

Study Arms (3)

Cohort A

EXPERIMENTAL

Participants will receive PF-08634404 IV.

Biological: PF-08634404

Cohort B

EXPERIMENTAL

Participants will receive PF-08634404 in combination with drug 1.

Biological: PF-08634404; Drug: Combination 1

Cohort C

EXPERIMENTAL

Participants will receive PF-08634404 IV in combination with drug 2.

Biological: PF-08634404; Drug: Combination 2

Interventions

PF-08634404 BIOLOGICAL

Concentrate for solution for infusion

Also known as: SSGJ-707

Cohort A; Cohort B; Cohort C

Combination 1 DRUG

Combination Drug 1

Cohort B

Combination 2 DRUG

Combination Drug 2

Cohort C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Acute, chronic or symptomatic infections
• Participants with history of immunodeficiency

Sponsors & Collaborators

• Pfizer: lead

Study Sites (49)

Highlands Oncology Group

Fayetteville, Arkansas, 72703, United States

RECRUITING

Highlands Oncology Group

Rogers, Arkansas, 72758, United States

RECRUITING

Highlands Oncology Group

Springdale, Arkansas, 72762, United States

RECRUITING

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

Duarte, California, 91010, United States

RECRUITING

City of Hope Investigational Drug Services (IDS)

Duarte, California, 91010, United States

RECRUITING

City of Hope Investigational Drug Services (IDS)

Irvine, California, 92618, United States

RECRUITING

City of Hope

Irvine, California, 92618, United States

RECRUITING

City of Hope

Long Beach, California, 90813, United States

RECRUITING

City of Hope UPLAND

Upland, California, 91786, United States

RECRUITING

Rocky Mountain Cancer Centers, LLP

Denver, Colorado, 80218, United States

RECRUITING

City Of Hope - Chicago

Zion, Illinois, 60099, United States

RECRUITING

Minnesota Oncology Hematology, P.A.

Burnsville, Minnesota, 55337, United States

RECRUITING

Minnesota Oncology Hematology, P.A.

Chaska, Minnesota, 55318, United States

RECRUITING

Minnesota Oncology Hematology, P.A.

Coon Rapids, Minnesota, 55433, United States

RECRUITING

Minnesota Oncology Hematology, P.A.

Edina, Minnesota, 55435, United States

RECRUITING

Minnesota Oncology Hematology, P.A.

Maple Grove, Minnesota, 55369, United States

RECRUITING

Minnesota Oncology Hematology, P.A.

Maplewood, Minnesota, 55109, United States

RECRUITING

Minnesota Oncology Hematology, P.A.

Woodbury, Minnesota, 55125, United States

RECRUITING

New York Oncology Hematology, P.C.

Albany, New York, 12206, United States

NOT YET RECRUITING

New York Oncology Hematology - Clifton Park Cancer Center

Clifton Park, New York, 12065, United States

NOT YET RECRUITING

Grand Strand Medical Center

Myrtle Beach, South Carolina, 295724607, United States

RECRUITING

Carolina Urologic Research Center, LLC

Myrtle Beach, South Carolina, 29572, United States

RECRUITING

Parkway Surgery Center

Myrtle Beach, South Carolina, 29572, United States

RECRUITING

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

RECRUITING

SCRI Oncology Partners

Nashville, Tennessee, 37203, United States

RECRUITING

Texas Oncology - Central South

Austin, Texas, 78731, United States

RECRUITING

Texas Oncology - Central South

Austin, Texas, 78758, United States

RECRUITING

Texas Oncology - Gulf Coast

Beaumont, Texas, 77702, United States

RECRUITING

Texas Oncology - Gulf Coast

Houston, Texas, 77024, United States

RECRUITING

Texas Oncology - Gulf Coast

Houston, Texas, 77054, United States

RECRUITING

US Oncology Investigational Products Center (IPC)

Irving, Texas, 75063, United States

RECRUITING

US Oncology Investigational Products Center

Irving, Texas, 75063, United States

RECRUITING

Texas Oncology - Central South

McAllen, Texas, 78503, United States

RECRUITING

Texas Oncology - Gulf Coast

Pearland, Texas, 77584, United States

RECRUITING

Texas Oncology - Gulf Coast

Sugar Land, Texas, 77479, United States

RECRUITING

Texas Oncology - Gulf Coast

The Woodlands, Texas, 77380, United States

RECRUITING

Texas Oncology - Gulf Coast

Webster, Texas, 77598, United States

RECRUITING

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

Blacksburg, Virginia, 24060, United States

RECRUITING

Virginia Cancer Specialists, PC

Fairfax, Virginia, 22031, United States

RECRUITING

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

Low Moor, Virginia, 24457, United States

RECRUITING

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

Roanoke, Virginia, 24014, United States

RECRUITING

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

Salem, Virginia, 24153, United States

RECRUITING

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

Wytheville, Virginia, 24382, United States

RECRUITING

Minnesota Oncology Hematology, P.A.

Hudson, Wisconsin, 54016, United States

RECRUITING

Icon Cancer Centre Wesley

Auchenflower, Queensland, 4066, Australia

RECRUITING

The University of Osaka Hospital

Suita, Osaka, 565-0871, Japan

NOT YET RECRUITING

Keio university hospital

Shinjuku-ku, Tokyo, 1608582, Japan

RECRUITING

National Hospital Organization Kyushu Cancer Center

Fukuoka, 811-1395, Japan

RECRUITING

Yamagata University Hospital

Yamagata, 990-9585, Japan

RECRUITING

Related Links

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

MeSH Terms

Conditions

Carcinoma, Renal Cell; Kidney Neoplasms; Clear-cell metastatic renal cell carcinoma; Carcinoma; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Adenocarcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Central Study Contacts

Pfizer CT.gov Call Center

CONTACT

1-800-718-1021; ClinicalTrials.gov_Inquiries@pfizer.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2025
• First Posted: November 12, 2025
• Study Start: March 12, 2026
• Primary Completion (Estimated): November 2, 2027
• Study Completion (Estimated): November 1, 2028
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1); JP (4); US (44)