PF-08634404 for Kidney Cancer

Recruiting at 46 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Pfizer

Disqualifiers: Active brain lesions, Autoimmune diseases, Other malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Up to approximately 3 years

224 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new medicine, PF-08634404, for adults with advanced kidney cancer. The goal is to observe the cancer's response to the medicine and assess its safety when used alone or with other cancer medicines. Adults with advanced renal cell carcinoma that has spread and who have not yet received treatment may be eligible to join. Participants will receive the medicine through an IV at a clinic, either alone or with another drug. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the new medicine PF-08634404 is still under investigation for its safety in people with advanced kidney cancer. Although complete safety information is not yet available, some effects have been observed. Previous studies noted side effects similar to those seen with treatments combining chemotherapy with PD-1 inhibitors and drugs that prevent tumors from forming new blood vessels.

As the trial is in its early stages, researchers are determining the safest dose and monitoring for side effects. So far, the medicine is being tested both alone and with other cancer treatments. This approach helps doctors understand how PF-08634404 works and what side effects might occur when used alone or in combination. Like many new treatments, some side effects may occur, but the study aims to find a safe way to use this medicine in people with kidney cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about PF-08634404 for kidney cancer because it introduces a novel approach to treatment. Unlike current standards like tyrosine kinase inhibitors or immune checkpoint inhibitors, PF-08634404 offers a potentially new mechanism of action that may enhance effectiveness. In particular, the combination of PF-08634404 with other drugs in different cohorts could provide a more comprehensive attack on cancer cells. This multi-armed approach allows researchers to explore various synergies and find the most effective treatment strategy, potentially leading to better outcomes for patients.

What evidence suggests that this trial's treatments could be effective for advanced kidney cancer?

Research has shown that PF-08634404 is under investigation as a potential treatment for advanced kidney cancer, specifically Renal Cell Carcinoma (RCC). In this trial, participants will receive PF-08634404 either alone or alongside other cancer treatments. Early results suggest that combining PF-08634404 with other treatments might enhance its effectiveness. Although exact numbers are not yet available, these combination therapies are expected to target cancer cells more effectively. Overall, this new treatment approach appears promising for individuals with advanced RCC. ^{1 2 6 7 8}

Who Is on the Research Team?

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Are You a Good Fit for This Trial?

Inclusion Criteria

I have not had drug treatments for kidney cancer, except immunotherapy over a year ago.

I have at least one tumor that has not been treated yet.

I am fully active or can do light work despite some symptoms.

Exclusion Criteria

I have active cancer that has spread to my brain or spinal cord.

I have had serious digestive tract problems like varices, ulcers, or abscesses.

I have had another cancer within the past 3 years.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive PF-08634404 alone or in combination with other anticancer medicines through IV infusions

Up to approximately 3 years

Regular visits at clinical study sites

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 37 days after the last dose of treatment

What Are the Treatments Tested in This Trial?

Interventions

• PF-08634404

How Is the Trial Designed?

Group I: Cohort C Experimental Treatment 2 Interventions

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

Group II: Cohort B Experimental Treatment 2 Interventions

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

Group III: Cohort A Experimental Treatment 1 Intervention

Participants will receive PF-08634404 IV.

Who Is Running the Clinical Trial?

Pfizer

Lead Sponsor

Trials

4,712

Recruited

50,980,000+

Known For

Vaccine Innovations

Top Products

Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Citations

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clinicaltrials.gov

clinicaltrials.gov/study/NCT07227415

NCT07227415 | Symbiotic-GU-08: A Study to Learn About ...

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 ...

2.

dana-farber.org

dana-farber.org/clinical-trials/26-099

AN INTERVENTIONAL PHASE 1B/2 STUDY TO ...

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 ...

3.

theglobeandmail.com

theglobeandmail.com/investing/markets/markets-news/Tipranks/1202687/pfizer-targets-advanced-kidney-cancer-with-new-pf-08634404-trial-what-investors-should-know/

Pfizer Targets Advanced Kidney Cancer With New PF ...

It is being tested alone and in combination with two other anticancer regimens to see whether it can improve outcomes in advanced kidney cancer.

4.

s206.q4cdn.com

s206.q4cdn.com/795948973/files/doc_events/2025/Nov/10/PfizerPflash_-4404-SITC-IR-Event-2025_FINAL.pdf

Pfizer Pflash: A Spotlight on the PF'4404 (SSGJ-707 / PF ...

Epidemiology data are rounded, and sourced from US CancerMPact Patient Metrics, Oracle (2025), includes total incident and newly recurrent ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11534105/

Real-world effectiveness of first- and second-line anti ... - PMC

Patients with localized kidney cancer have a 5-year survival rate approaching 93%, but this drops to 14% for patients with advanced/metastatic ...

6.

cancer.gov

cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2026-00339

A Study to Learn About the Medicine Called PF-08634404 ...

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 ...

7.

usoncology.com

usoncology.com/patients/clinical-trials/25176-renal-cancer-na-304/

25176-Renal Cancer-NA-304

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 ...

8.

clinicaltrials.eu

clinicaltrials.eu/trial/a-study-of-pf-08634404-ipilimumab-and-axitinib-in-adults-with-advanced-or-metastatic-kidney-cancer/

A study of PF-08634404, ipilimumab, and axitinib in adults ...

This study is being conducted to evaluate the safety and effectiveness of the drug PF-08634404 when used alone or in combination with other medicines for ...