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

Recruiting now · Phase 1/Phase 2

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

In brief

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.

Key facts

Study ID

NCT07227415

Run by

Pfizer

People needed

224

Starts

2026-02-10

Expected to finish

2028-11-01

Last updated by the study team

2026-07-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

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 or acute gastrointestinal bleeding within 6 months prior to the first dose
• Acute, chronic or symptomatic infections
• Participants with history of immunodeficiency

Where it is running

• Minnesota Oncology Hematology, P.A. — Chaska, Minnesota, United States (enrolling)
• Mayo Clinic Hospital, Methodist Campus, Research Pharmacy — Rochester, Minnesota, United States (enrolling)
• Dana Farber/Mass General Brigham Cancer Care, Inc — Boston, Massachusetts, United States (enrolling)
• Minnesota Oncology Hematology, P.A. — Burnsville, Minnesota, United States (enrolling)
• Minnesota Oncology Hematology, P.A. — Maple Grove, Minnesota, United States (enrolling)
• Minnesota Oncology Hematology, P.A. — Maplewood, Minnesota, United States (enrolling)
• Tennessee Oncology, PLLC- Ringgold — Ringgold, Georgia, United States (enrolling)
• Brigham and Women's Hospital — Boston, Massachusetts, United States (enrolling)
• Mayo Clinic Building- Phoenix — Phoenix, Arizona, United States (enrolling)
• Dana-Farber Cancer Institute - Chestnut Hill — Newton, Massachusetts, United States (enrolling)
• Minnesota Oncology Hematology, P.A. — Edina, Minnesota, United States (enrolling)
• Highlands Oncology Group — Fayetteville, Arkansas, United States (enrolling)
• City of Hope Investigational Drug Services (IDS) — Duarte, California, United States (enrolling)
• City of Hope — Long Beach, California, United States (enrolling)
• Highlands Oncology Group — Rogers, Arkansas, United States (enrolling)
• Mayo Clinic Arizona — Scottsdale, Arizona, United States (enrolling)
• City of Hope Investigational Drug Services (IDS) — Irvine, California, United States (enrolling)
• City Of Hope - Chicago — Zion, Illinois, United States (enrolling)
• City of Hope UPLAND — Upland, California, United States (enrolling)
• City of Hope — Irvine, California, United States (enrolling)
• Rocky Mountain Cancer Centers, LLP — Denver, Colorado, United States (enrolling)
• Highlands Oncology Group — Springdale, Arkansas, United States (enrolling)
• City of Hope (City of Hope National Medical Center, City of Hope Medical Center) — Duarte, California, United States (enrolling)
• Minnesota Oncology Hematology, P.A. — Coon Rapids, Minnesota, United States (enrolling)
• Mayo Clinic Cancer Center Outpatient Pharmacy — Rochester, Minnesota, United States (enrolling)

Full record on ClinicalTrials.gov

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