Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Casdatifan · 7 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.
| 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 |
| Treatment A | EXPERIMENTAL | Participants will receive 4 X 25 mg tablets of casdatifan. |
| Treatment B | EXPERIMENTAL | Participants will receive 1 X 100 mg tablets of casdatifan. |
| Treatment C | EXPERIMENTAL | Participants will receive 4 X 25 mg tablets of casdatifan under fed conditions. |
| Casdatifan-Itraconazole-Phenytoin | EXPERIMENTAL | Participants will receive casdatifan, itraconazole, and phenytoin. |
| Casdatifan - Sequence ABC | EXPERIMENTAL | Participants will sequentially receive casdatifan capsules fasted (Treatment A), followed by casdatifan tablets fasted (Treatment B), followed by casdatifan tablets fed (Treatment C) |
| Casdatifan - Sequence BCA | EXPERIMENTAL | Participants will sequentially receive Treatment B, followed by Treatment C, then Treatment A |
| Casdatifan - Sequence CAB | EXPERIMENTAL | Participants will sequentially receive Treatment C, followed by Treatment A, then Treatment B |
| 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 |
| SAD-casdatifan Dose 1 | EXPERIMENTAL | Participants will receive "Dose 1" of casdatifan orally with water under fasting conditions. |
| SAD-casdatifan Dose 2 | EXPERIMENTAL | Participants will receive "Dose 2" of casdatifan orally with water under fasting conditions. |
| SAD-casdatifan Dose 3 | EXPERIMENTAL | Participants will receive "Dose 3" of casdatifan orally with water under fasting conditions. |
| SAD-casdatifan Dose 4 | EXPERIMENTAL | Participants will receive "Dose 4" of casdatifan orally with water under fasting conditions. |
| SAD-Placebo | PLACEBO_COMPARATOR | Participants will receive matching placebo orally with water under fasting conditions. |
| MAD-casdatifan Dose 1 | EXPERIMENTAL | Participants will receive "Dose 1" of casdatifan orally with water under fasting conditions. |
| MAD-casdatifan Dose 2 | EXPERIMENTAL | Participants will receive "Dose 2" of casdatifan orally with water under fasting conditions. |
| MAD-Placebo | PLACEBO_COMPARATOR | Participants will receive matching placebo orally with water under fasting conditions. |
| DDI-casdatifan Dose + Midazolam | EXPERIMENTAL | Participants will receive highest safe dose level of casdatifan from MAD and midazolam orally with water under fasting conditions |
| 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. |
| Itraconazole | DRUG | Administered as multiple doses in treatment Period 2 |
| Phenytoin | DRUG | Administered as multiple doses in treatment Period 3 |
| Ipilimumab | DRUG | Administered as specified in the treatment arm |
| Midazolam | DRUG | Syrup solution |
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 developed for renal cell carcinoma, including metastatic clear cell renal cell carcinoma and clear cell renal cell carcinoma. It is currently in Phase 3 clinical development for these oncology indications.
Casdatifan is being developed by Arcus Biosciences, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol RCUS.
Casdatifan is in Phase 3 clinical development for renal cell carcinoma. It is an investigational drug and has not been approved by regulatory authorities. The drug is also being studied in earlier-phase trials in healthy participants.
Casdatifan has been studied in four clinical trials. Three Phase 1 trials in healthy participants are completed: NCT05117554, NCT05999513, and NCT06919991. One Phase 1 trial, NCT07641881, is currently recruiting healthy participants in the United States.
Yes, Casdatifan is also known as AB521. Early clinical trials, including NCT05117554 and NCT05999513, used the name AB521 to refer to the same drug substance.