casdatifan
casdatifan: developed by 1 company · 10 clinical trials tracked.
casdatifan evidence translation
What we can confirm
10 tracked trials
What it means
What to watch
Prepared research question
How could casdatifan → RCUS affect its developer, and what evidence supports the link?
Traceable citations · Unknowns marked
See linked entities and source evidence7 indications · 3 study sponsors
Related indications
Development Pipeline (1)
| Company | Phase |
|---|---|
| Arcus Biosciences, Inc. (RCUS) Renal Cell Carcinoma; Clear Cell Renal Cell Carcinoma; Healt… | Phase 3 |
Clinical Trials (10)
A Pilot Study of HIF-Mediated Gene Expression Changes in Casdatifan-Treated Refractory Renal Cell Carcinoma
Primary endpoint: To determine the change in expression of predefined HIF2-regulated target genes in metastatic tumor tissue following casdatifan therapy in a refractory ccRCC population.
A Phase 1, Open-Label, Single-Dose, Parallel-Group Study to Evaluate the Pharmacokinetics of Casdatifan (AB521) in Participants With Moderate Hepatic Impairment Compared to Healthy Matched Participants
Primary endpoint: Area under the concentration time curve, from time 0 to the last observed non-zero concentration, of casdatifan in plasma (AUC0-t)
PRE-surgical NEOadjuvant Sandwich Immunotherapy With HIF inhibiTion in Renal Cell Carcinoma (PRENEOSHIFT-RCC)
Primary endpoint: Tumor Size Reduction Rate
A Phase 1, Open-Label, Randomized, Single-Dose, Three-Treatment, Three-Period, Six-Sequence Crossover Pharmacokinetic Study to Evaluate the Bioequivalence of Two Casdatifan (AB521) Tablet Strengths and Food Effect in Healthy Adult Participants
Primary endpoint: Maximum observed concentration for casdatifan
ROSETTA RCC-208: A Phase 1/2 Open-label, Multi-center, Randomized Study of Pumitamig Alone or in Combination With Other Agents in Participants With Advanced Renal Cell Carcinoma (RCC)
Primary endpoint: Number of participants with adverse events (AEs)
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
Primary endpoint: Progression-free Survival (PFS) as assessed by Blinded Independent Central Review (BICR) according to RECIST 1.1
A Phase Ib/III Randomized, Multicenter, Global Study of Volrustomig Plus Casdatifan or Volrustomig Monotherapy Versus Nivolumab Plus Ipilimumab as First-line Treatment for Participants With Advanced Clear Cell Renal Cell Carcinoma (ccRCC)
Primary endpoint: Number of participants with adverse events (AEs) and serious adverse events (SAEs)
A Phase 1, Open-Label, Fixed-Sequence, Drug-Drug Interaction Study of Casdatifan With Itraconazole (Strong CYP3A4 Inhibitor) and Phenytoin (Strong CYP3A4 Inducer) in Healthy Adult Participants
Primary endpoint: Area Under the Plasma Drug Concentration-Time Curve (AUC) for casdatifan
A Phase 1b/2 Dose-finding and Expansion Study Evaluating the Safety and Efficacy of Zanzalintinib (XL092) Combined With Either AB521 or AB521 Plus Nivolumab in Subjects With Advanced Clear Cell Renal Cell Carcinoma or Other Advanced Solid Tumors.
Primary endpoint: Dose-finding Stage: Number of participants with dose-limiting toxicities (DLTs)
A Phase 1, Open-label, Dose Escalation and Dose Expansion Study, to Investigate the Safety, Tolerability, and Pharmacokinetic Profile of AB521 Monotherapy and Combination Therapies in Participants With Clear Cell Renal Cell Carcinoma and Other Solid Tumors
Primary endpoint: Number of participants with dose limiting toxicities (DLTs)
Frequently asked questions
Who is developing casdatifan?
casdatifan is being developed by Arcus Biosciences, Inc..
How many clinical trials involve casdatifan?
BioSniper tracks 10 clinical trials involving casdatifan.