Clinical Trials List
Protocol NumberPEAK-1
NCT Number(ClinicalTrials.gov Identfier)NCT07011719
Not yet recruiting
2026-05-01 - 2030-05-31
Phase III
Not yet recruiting1
A Randomized, Double-Blind, Active-Control, Multicenter Phase 3 Trial of Casdatifan and Cabozantinib Versus Placebo and Cabozantinib in Patients with Advanced Clear Cell Renal Cell Carcinoma
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Trial Applicant
Syneos Health
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Sponsor
Taiwan Syneos Health Company Limited
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Trial scale
Multi-Regional Multi-Center
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Update
2026/09/10
Investigators and Locations
Co-Principal Investigator
- 吳宗哲 無
- JHE-CYUAN GUO 無
- FU-JEN HSUEH 無
- Jih-Hsiang Lee 無
- Yu-Chieh Tsai 無
- 徐偉勛 無
Co-Principal Investigator
- 吳紋綺 Division of Hematology & Oncology
- 蔡承翰 無
- Yi-Hsiu Huang 無
- Ming-Hsuan Ku 無
- Jiun-I Lai Division of Hematology & Oncology
- Tzu-Hao Huang 無
- Chueh-Chuan Yen Division of Hematology & Oncology
- Chih-Chieh Lin 無
- Tzu-chun Wei 無
- 沈書慧 無
- Hsiao-Jen Chung 無
- Yen-Hwa Chang 無
Principal Investigator
See-Tong Pang
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Condition/Disease
Advanced Clear Cell Renal Cell Carcinoma
Objectives
The purpose of the study is to evaluate the progression-free survival (PFS) of casdatifan versus placebo when each is given in combination with cabozantinib in adult patients with confirmed advanced or metastatic clear cell Renal Cell Carcinoma who have experienced progression on or after prior anti-PD-1 or anti-PD-L1 immunotherapy.
Official Title
Test Drug
AB521 (Casdatifan) 25mg/ Placebo 30 tablets/bottle
Active Ingredient
Casdatifan
Dosage Form
Tablets
Dosage
25mg
Endpoints
Experimental: Arm A (Experimental Arm)Casdatifan and cabozantinib taken orallyDrug: CasdatifanAdministered as specified in the treatment armOther Names:AB521Drug: CabozantinibAdministered as specified in the treatment arm
Placebo Comparator: Arm B (Comparator Arm)Placebo and cabozantinib taken orallyDrug: CabozantinibAdministered as specified in the treatment armDrug: PlaceboAdministered as specified in the treatment arm
Placebo Comparator: Arm B (Comparator Arm)Placebo and cabozantinib taken orallyDrug: CabozantinibAdministered as specified in the treatment armDrug: PlaceboAdministered as specified in the treatment arm
Inclution Criteria
Unresectable and measurable locally advanced or metastatic renal cell carcinoma with a primary clear cell component.
A Karnofsky Performance Status (KPS) score ≥ 80%
At least 1 target lesion measurable by computed tomography/magnetic resonance imaging per RECIST 1.1, not within a field of prior radiation therapy.
Adequate organ and marrow function, ≤ 1 week prior to randomization.
Women of childbearing potential (WOCBP) must have a negative serum pregnancy test.
A Karnofsky Performance Status (KPS) score ≥ 80%
At least 1 target lesion measurable by computed tomography/magnetic resonance imaging per RECIST 1.1, not within a field of prior radiation therapy.
Adequate organ and marrow function, ≤ 1 week prior to randomization.
Women of childbearing potential (WOCBP) must have a negative serum pregnancy test.
Exclusion Criteria
Received prior treatment with a HIF-2α inhibitor or cabozantinib.
Other prior malignancy active within the previous year except for locally curable cancers that have been apparently cured.
Ongoing clinically significant toxicities related to any prior anticancer treatment, or toxicities Grade ≥ 3 per National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI CTCAE v5.0) regardless of relatedness to prior anticancer therapies.
Uncontrolled or poorly controlled hypertension, defined as a sustained blood pressure > 150 mmHg systolic or > 90 mmHg diastolic despite optimal antihypertensive treatment.
History of leptomeningeal disease or spinal cord compression.
Other prior malignancy active within the previous year except for locally curable cancers that have been apparently cured.
Ongoing clinically significant toxicities related to any prior anticancer treatment, or toxicities Grade ≥ 3 per National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI CTCAE v5.0) regardless of relatedness to prior anticancer therapies.
Uncontrolled or poorly controlled hypertension, defined as a sustained blood pressure > 150 mmHg systolic or > 90 mmHg diastolic despite optimal antihypertensive treatment.
History of leptomeningeal disease or spinal cord compression.
The Estimated Number of Participants
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Taiwan
9 participants
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Global
720 participants
