Clinical trial · Interventional
Study of Casdatifan and Cabozantinib Versus Placebo and Cabozantinib in Patients With Advanced Clear Cell Renal Cell Carcinoma
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 30, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260930-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Clear Cell Renal Cell Carcinoma | Clear Cell Renal Cell Carcinoma | CURATED_BROADER | 0.78 |
| Metastatic Clear Cell Renal Cell Carcinoma | Clear Cell Renal Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cabozantinib | Drug | Cabozantinib | ALIAS |
| Casdatifan | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A (Experimental Arm)
- description
- Casdatifan and cabozantinib taken orally
- interventionNames
- Drug: Casdatifan
- Drug: Cabozantinib
- type
- PLACEBO_COMPARATOR
- label
- Arm B (Comparator Arm)
- description
- Placebo and cabozantinib taken orally
- interventionNames
- Drug: Cabozantinib
- Drug: Placebo
Primary outcomes (1)
- measure
- Progression-free Survival (PFS) as assessed by Blinded Independent Central Review (BICR) according to RECIST 1.1
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion 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. 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. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
References
Publications (1)
- DERIVEDMailyan AK, Mata G, Beatty JW, Drew SL, Fournier J, Yu K, Gal B, Kalisiak J, Yan X, Tran A, Su Y, Rosen BR, Jeffrey JL, Hardman C, Epplin M, Ginn E, Sun M, Chen A, Fabila P, Sivick KE, Schweickert PG, Piovesan D, Meleza C, Pham AT, Chen PY, Jin L, Walters MJ, Walker NP, Kwon HJ, Leleti MR, Powers JP, Lawson KV. Discovery of Casdatifan, Part II: A Potent and Orally Bioavailable Inhibitor of Hypoxia Inducible Factor-2alpha. J Med Chem. 2026 Jun 25;69(12):14952-14988. doi: 10.1021/acs.jmedchem.5c03724. Epub 2026 Jun 5. PMID 42246926