PF-08634404 for Advanced or metastatic renal cell carcinoma

Inclusion criteria

• {"criterion_text":"- 18 years of age or older at screening\n- Locally advanced (not amenable to curative surgery or radiation therapy) or metastatic RCC with diagnosis confirmed by histology/cytology\n- At least one measurable (as defined by the investigator) and untreated lesion\n- Adequate hematologic, hepatic, cardiac and renal function\n- No prior systemic therapy for RCC (immunotherapy after surgery is allowed if received >12 months prior)\n- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.\n- All International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) based risk categories."}

Exclusion criteria

• {"criterion_text":"- Known active brain lesions including leptomeningeal metastasis, brainstem, meningeal or spinal cord metastases or compression.\n- Acute, chronic or symptomatic infections\n- Participants with history of immunodeficiency\n- Clinically significant risk of haemorrhage or fistula\n- History of another malignancy within 3 years\n- History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.\n- Active autoimmune diseases requiring systemic treatment within the past 2 years\n- Uncontrolled cardiac and other comorbidities within 6 months prior to the first dose\n- Major surgery or severe trauma within 4 weeks before the first dose, or planned major surgery during the study\n- History of severe bleeding tendency or coagulation dysfunction\n- History of oesophageal varices, severe ulcers, gastrointestinal perforation, abdominal fistula, gastrointestinal obstruction, intra-abdominal abscess"}

Primary endpoints

• {"endpoint_text":"- Cohort A: Confirmed objective response rate (ORR) using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by the investigator","definition_or_measurement_approach":"ORR assessed per RECIST 1.1 by investigator; confirmed responses counted according to RECIST 1.1 criteria."}
• {"endpoint_text":"- Cohort A: Adverse events (AEs) as characterized by type, frequency, intensity as graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0, timing, seriousness, and relationship to study intervention(s)","definition_or_measurement_approach":"AEs graded and characterized using NCI CTCAE v5.0; assessment includes type, frequency, intensity, timing, seriousness, and relationship to interventions."}
• {"endpoint_text":"- Cohort B/C: Dose limiting toxicities (DLTs) in the first cycle (Part 1)","definition_or_measurement_approach":"DLTs assessed during first cycle in Part 1 to inform dose escalation decisions."}
• {"endpoint_text":"- Cohort B/C: AEs as characterized by type, frequency, intensity as graded by NCI CTCAE version 5.0, timing, seriousness, and relationship to study intervention(s).","definition_or_measurement_approach":"AEs graded and characterized using NCI CTCAE v5.0; assessment includes type, frequency, intensity, timing, seriousness, and relationship to interventions."}
• {"endpoint_text":"- Cohort B/C: Confirmed ORR using RECIST 1.1 as assessed by investigator","definition_or_measurement_approach":"ORR assessed per RECIST 1.1 by investigator; confirmed responses per RECIST 1.1."}

Secondary endpoints

• {"endpoint_text":"- Cohort A: - Duration of response (DoR) using RECIST 1.1 as assessed by investigator - Progression-free survival (PFS) using RECIST 1.1 as assessed by investigator - Overall survival (OS)","definition_or_measurement_approach":"DoR and PFS assessed per RECIST 1.1 by investigator; OS measured as time to death from any cause."}
• {"endpoint_text":"- Cohort A: Laboratory test abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0) and timing","definition_or_measurement_approach":"Laboratory abnormalities graded per NCI CTCAE v5.0 and summarized by type, frequency, severity, and timing."}
• {"endpoint_text":"- Cohort A: Predose and post dose concentrations of PF-08634404.","definition_or_measurement_approach":"Pharmacokinetic measurements of PF-08634404 concentrations pre-dose and post-dose."}
• {"endpoint_text":"- Cohort A: Incidence of antidrug antibodies (ADA) against PF-08634404","definition_or_measurement_approach":"Immunogenicity assessed by measuring incidence of ADA to PF-08634404."}
• {"endpoint_text":"- Cohort B/C: - DoR using RECIST 1.1 as assessed by investigator - PFS using RECIST 1.1 as assessed by investigator - OS","definition_or_measurement_approach":"DoR and PFS assessed per RECIST 1.1 by investigator; OS measured as time to death from any cause."}
• {"endpoint_text":"- Cohort B/C: Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0) and timing","definition_or_measurement_approach":"Laboratory abnormalities graded per NCI CTCAE v5.0 and summarized by type, frequency, severity, and timing."}
• {"endpoint_text":"- Cohort B/C: Predose and post dose concentrations of PF-08634404","definition_or_measurement_approach":"Pharmacokinetic measurements of PF-08634404 concentrations pre-dose and post-dose."}
• {"endpoint_text":"- Cohort B/C: Incidence of ADA against PF-08634404","definition_or_measurement_approach":"Immunogenicity assessed by measuring incidence of ADA to PF-08634404."}

Germany

Earliest CTIS Part Ii Submission Date

20-03-2026

Latest Decision Or Authorization Date

22-04-2026

Processing Time Days

33

Number Of Sites

4

Number Of Participants

18

Spain

Earliest CTIS Part Ii Submission Date

09-04-2026

Latest Decision Or Authorization Date

21-04-2026

Processing Time Days

12

Number Of Sites

7

Number Of Participants

32

Primary sponsor

Full Name

Pfizer Inc.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

Iqvia Inc.

Responsibilities

code 7

Name

Icon Clinical Research Limited

Responsibilities

code 4

Name

PPD Development LP

Responsibilities

code 4

Name

QPS LLC

Responsibilities

code 4

Third parties

• {"country":"United States","full_name":"Azenta","duties_or_roles":"code 4","organisation_type":"Industry"}
• {"country":"United States","full_name":"Iqvia Inc.","duties_or_roles":"code 7","organisation_type":"Pharmaceutical company"}
• {"country":"Belgium","full_name":"Cellcarta NV - Belgium","duties_or_roles":"code 4","organisation_type":"Industry"}
• {"country":"China","full_name":"UNITED POWER PHARMA TECH","duties_or_roles":"code 4","organisation_type":"Industry"}
• {"country":"United States","full_name":"Clario","duties_or_roles":"code 15 (Medical Imaging)","organisation_type":"Health care"}
• {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Fulgent Genetics Inc.","duties_or_roles":"code 4","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Personalis Inc.","duties_or_roles":"code 4","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"QPS LLC","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
• {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Guardant Health","duties_or_roles":"code 4","organisation_type":"Industry"}