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Also known as AB521, C21H17F4NO3S
casdatifan · 4 trials · 9 indications
Tumor size reduction rate is defined as the proportion of participants who achieve any decrease in the maximal dimension of the primary tumor.
A serial biopsy design, incorporating biopsies at baseline, on-treatment, and disease progression, enables longitudinal evaluation of the HIF-2α transcriptional program and characterization of adaptive or resistance-associated gene expression changes emerging during therapy.
| Arm | Type | Description |
|---|---|---|
| Arm A (Experimental Arm) | EXPERIMENTAL | Casdatifan and cabozantinib taken orally |
| Arm B (Comparator Arm) | PLACEBO_COMPARATOR | Placebo and cabozantinib taken orally |
| Group A: Casdatifan | EXPERIMENTAL | 16 participants will be enrolled and will complete the following: * Baseline visit * Cycle 1 through 3 (21 day cycles): --Days 1 - 21: Predetermined dose of Casdatifan 1x daily * standard of care nephrectomy * Follow up for up to 3 years |
| Group B: Casdatifan + Zimberelimab | EXPERIMENTAL | * 16 participants will be enrolled and will complete the following: * Baseline visit * Cycle 1 through 3 (21 day cycles): * Days 1 - 21: Predetermined dose of Casdatifan 1x daily * Day 1: Predetermined dose of Zimberelimab * Standard of care nephrectomy * Follow up for up to 3 years |
| Casdatifan | EXPERIMENTAL | Casdatifan will be taken orally at a fixed dose of 100 mg once daily, with or without food, on a continuous schedule beginning on Cycle 1, Day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan or MRI, tumor biopsy and blood sample collection throughout the study. |
| Dose Escalation Cohort 1 | EXPERIMENTAL | Participants will receive casdatifan orally once daily |
| Dose Escalation Cohort 2 | EXPERIMENTAL | Participants will receive casdatifan orally once daily |
| Dose Escalation Cohort 3 | EXPERIMENTAL | Participants will receive casdatifan orally twice daily |
| Dose Escalation Cohort 4 | EXPERIMENTAL | Participants will receive casdatifan orally once daily |
| Dose Escalation Cohort 5 | EXPERIMENTAL | Participants will receive casdatifan orally once daily |
| Dose Expansion Cohort 1 | EXPERIMENTAL | Participants will receive casdatifan orally |
| Dose Expansion Cohort 2 | EXPERIMENTAL | Participants will receive casdatifan orally |
| Dose Expansion Cohort 3 | EXPERIMENTAL | Participants will receive casdatifan orally |
| Dose Expansion Cohort 4 | EXPERIMENTAL | Participants will receive casdatifan orally with with cabozantinib orally |
| Dose Expansion Cohort 5 | EXPERIMENTAL | Participants will receive casdatifan orally |
| Dose Expansion Cohort 6 | EXPERIMENTAL | Participants will receive casdatifan orally |
| Dose Expansion Cohort 7 | EXPERIMENTAL | Participants will receive casdatifan orally with zimberelimab infusion |
| Dose Expansion Cohort 8 | EXPERIMENTAL | Participants will receive casdatifan orally |
| Dose Expansion Cohort 9 | EXPERIMENTAL | Participants will receive casdatifan orally with zimberelimab infusion and ipilimumab infusion |
| Dose Expansion Cohort 10 | EXPERIMENTAL | Participants will receive casdatifan orally with zimberelimab infusion and ipilimumab infusion |
| Name | Type | Description |
|---|---|---|
| Casdatifan | DRUG | Administered as specified in the treatment arm |
| Cabozantinib | DRUG | Administered as specified in the treatment arm |
| Placebo | DRUG | Administered as specified in the treatment arm |
| Zimberelimab | DRUG | monoclonal antibody, multi-dose vial, via intravenous (through the vein) infusion, per protocol. |
| Ipilimumab | DRUG | Administered as specified in the treatment arm |
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 w...
Casdatifan is an investigational small molecule being studied for clear cell renal cell carcinoma, including metastatic, advanced, and refractory forms, as well as renal cell carcinoma more broadly. It is also being evaluated in other solid tumors. It is not approved and remains in clinical development.
Casdatifan is being developed by Arcus Biosciences, Inc., which trades under the ticker RCUS. The company is running the clinical program across Phase 1, Phase 2, and Phase 3 studies in renal cell carcinoma.
Casdatifan is in clinical development, with studies spanning Phase 1 through Phase 3. The Phase 1 program includes NCT05536141 and NCT07748988, while NCT07011719 is a Phase 3 trial. It is investigational and has not been approved by the FDA.
Casdatifan is being studied in NCT07748988, a Phase 1 trial in refractory metastatic clear cell renal cell carcinoma; NCT05536141, a Phase 1 study in renal cell carcinoma and other solid tumors; NCT07397611, a Phase 2 neoadjuvant study in renal cell carcinoma; and NCT07011719, a Phase 3 trial in advanced clear cell renal cell carcinoma.
Yes, casdatifan is also known as AB521. The Phase 1 study NCT05536141 is listed under the AB521 name, evaluating monotherapy and combination therapies in renal cell carcinoma and other solid tumors. Both names refer to the same investigational small molecule developed by Arcus Biosciences.
The casdatifan clinical program has a total planned enrollment of 720 patients across its trials. The Phase 3 trial NCT07011719 accounts for 720 participants, while the Phase 1 study NCT05536141 plans 362 and the Phase 2 study NCT07397611 plans 32.