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NCT Number: 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

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.

Recruiting

Interested in participating?

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PF-08634404

Drug

Concentrate for solution for infusion

Other names: SSGJ-707

Ipilimumab

Drug

Solution for infusion

Other names: yervoy

Axitinib

Drug

Tablet

Primary outcomes

  1. 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.

  2. 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.

  3. 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).

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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

  5. 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

  6. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Pfizer CT.gov Call Center

CONTACT

[email protected]

1-800-718-1021

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Nov 12, 2025
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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