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:
2.02552E+11
EU Trial (CTIS) Number:
2025-523524-53-00
Study Contact Information:
(210) 593-5651 or [email protected]
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.

The aim of this study was to evaluate the safety and efficacy response of PF-08634404 monotherapy and in combination with other anticancer drugs in participants of the advanced RCC study.

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.
Phase I/II
Sex
Female & Male
Age
18+ years
Study Drug
N/A
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 Applicants must be ≥18 years old at the time of screening.
  • Advanced or metastatic RCC that is confirmed by histology or cytology and contains clear cell components (not suitable for radical surgery or radiation therapy).
  • Organ function is good.
  • No prior systemic treatment for RCC is required (adjuvant immunotherapy following surgery is acceptable if it occurs more than 12 months prior).
  • The ECOG PS score is 0 or 1.
  • All IMDC risk categories.
  • Researchers determined that there were measurable lesions.
  • CFDA
  • Applicants must be ≥18 years old at the time of screening.
  • Advanced or metastatic RCC that is confirmed by histology or cytology and contains clear cell components (not suitable for radical surgery or radiation therapy).
  • Organ function is good.
  • No prior systemic treatment for RCC is required (adjuvant immunotherapy following surgery is acceptable if it occurs more than 12 months prior).
  • The ECOG PS score is 0 or 1.
  • All IMDC risk categories.
  • Researchers determined that there were measurable lesions.
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 Study participants with known active CNS metastases (including leptomeningeal, brainstem, meningeal, or spinal cord metastases or compression) were excluded.
  • There is a clinically significant risk of bleeding or fistula formation.
  • Study participants had a history of other malignant tumors within 3 years prior to the first administration of the study treatment intervention.
  • He has received allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
  • Study participants had an active autoimmune disease requiring systemic treatment within two years prior to the first administration of the study's therapeutic intervention.
  • Patients with uncontrolled cardiovascular disease or other comorbidities within 6 months prior to the first dose.
  • Those who have undergone major surgery or experienced significant trauma within 4 weeks prior to the first dose, or who plan to undergo major surgery during the study period.
  • A history of severe bleeding tendency or coagulation dysfunction.
  • History of esophageal varices, severe ulcers, gastrointestinal perforation, abdominal fistula, gastrointestinal obstruction, or intra-abdominal abscess.
  • Research participants who have acute, chronic, or symptomatic infections.
  • Research participants with a history of immunodeficiency.
  • CFDA
  • Study participants with known active CNS metastases (including leptomeningeal, brainstem, meningeal, or spinal cord metastases or compression) were excluded.
  • There is a clinically significant risk of bleeding or fistula formation.
  • Study participants had a history of other malignant tumors within 3 years prior to the first administration of the study treatment intervention.
  • He has received allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
  • Study participants had an active autoimmune disease requiring systemic treatment within two years prior to the first administration of the study's therapeutic intervention.
  • Patients with uncontrolled cardiovascular disease or other comorbidities within 6 months prior to the first dose.
  • Those who have undergone major surgery or experienced significant trauma within 4 weeks prior to the first dose, or who plan to undergo major surgery during the study period.
  • A history of severe bleeding tendency or coagulation dysfunction.
  • History of esophageal varices, severe ulcers, gastrointestinal perforation, abdominal fistula, gastrointestinal obstruction, or intra-abdominal abscess.
  • Research participants who have acute, chronic, or symptomatic infections.
  • Research participants with a 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
Recruiting
Condition(s) Treated at Site
Solid Tumor
Renal
Location
START Madrid, Spain (FJD)
Madrid, Spain, 28040
Investigator
Victor Moreno Garcia
Status
Will Be Recruiting
Condition(s) Treated at Site
Solid Tumor
Renal