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

Study Identifier:
C6461008
CT.gov Identifier:
NCT07227415
EudraCT Identifier:
202552000000
EU Trial (CTIS) Number:
2025-523524-53-00
Study Contact Information:
N/A
Recruiting

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Study 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.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Solid Tumor
  • Renal
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I/II
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: EXPERIMENTAL: Cohort A
    • Read More
  • Drug: Participants will receive PF-08634404 IV.
  • Drug: Drug: PF-08634404
  • Drug: Concentrate for solution for infusion
  • Drug: Other Names: SSGJ-707
  • Drug: EXPERIMENTAL: Cohort B
  • Drug: Participants will receive PF-08634404 in combination with drug 1.
  • Drug: Drug: Combination 1
  • Drug: Combination Drug 1
  • Drug: EXPERIMENTAL: Cohort C
  • Drug: Participants will receive PF-08634404 IV in combination with drug 2.
  • Drug: Drug: Combination 2
  • Drug: Combination Drug 2
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

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

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Carolinas
    Myrtle Beach, SC, United States, 29572
    Investigator
    Neal Shore
    Status
    Will Be Recruiting
    Condition(s) Treated at Site
    Solid Tumor
    Renal