NCT07227415 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
| NCT ID | NCT07227415 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Pfizer |
| Condition | Carcinoma, Renal Cell |
| Study Type | INTERVENTIONAL |
| Enrollment | 224 participants |
| Start Date | 2026-02-10 |
| Primary Completion | 2027-11-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 224 participants in total. It began in 2026-02-10 with a primary completion date of 2027-11-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Pfizer CT.gov Call Center
STUDY DIRECTOR
Pfizer
Frequently Asked Questions
Who can join the NCT07227415 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Carcinoma, Renal Cell. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07227415 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07227415 currently recruiting?
Yes, NCT07227415 is actively recruiting participants. Contact the research team at ClinicalTrials.gov_Inquiries@pfizer.com for enrollment information.
Where is the NCT07227415 trial being conducted?
This trial is being conducted at Phoenix, United States, Scottsdale, United States, Fayetteville, United States, Rogers, United States and 11 additional locations.
Who is sponsoring the NCT07227415 clinical trial?
NCT07227415 is sponsored by Pfizer. The principal investigator is Pfizer CT.gov Call Center at Pfizer. The trial plans to enroll 224 participants.