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NCT05536141 (casdatifan in 3L treatment for metastatic clear cell…): BVCT ex-ante prediction vs. reported outcome

On 14 Feb 2025, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 15 Feb 2025 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially TBD (wait for OS data).

Clinical Trial

NCTID
NCT05536141
Acronym
ARC-20
Drug Name
casdatifan (AB521)
Drug MoA
HIF2alpha inhibitor
Drug Modality
small molecule
Drug Class
Best-In-Class
Therapeutic Area
Neoplasms
Indication
3L treatment for metastatic clear cell renal cell carcinoma (ccRCC)
Human Patients
302
Sponsor
Arcus Biosciences
Phase
Phase 1

Prediction of , index 511

Prospective Prediction
Prediction Index
511
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient (additive) clinical benefit in OS non-inferior to cabozantinib as a monotherapy and superior to cabozantinib as a combotherapy)
Technical Prediction
SUCCESS (statistically significant (additive) clinical benefit in ORR/PFS compared with placebo)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
1 days in advance
Readout Data Interpretation
casdatifan 100mg QD achieved 33% ORR and >6.8 months mPFS; superior to belzutifan that achieved 22% ORR and 5.6 months mPFS; as 3L treatment for ccRCC (10.1056/NEJMoa2313906) and non-inferior to cabozantinib that achieved 21% ORR and 7.4m mPFS as 3L treatment for ccRCC (see the add'l link below)
Press Release
Additional Readout Data
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially TBD (wait for OS data)
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

ClinicalTrials.gov record, retrieved 2026-09-24. Third-party data.

Official title
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
Phase
Phase 1
Status
Recruiting
Enrollment
362
Lead sponsor
Arcus Biosciences, Inc.
Conditions
Clear Cell Renal Cell Carcinoma; Solid Tumors
Interventions
DRUG: casdatifan; DRUG: Cabozantinib; DRUG: Zimberelimab; DRUG: Ipilimumab
Design
Non randomized · Sequential · None
Primary purpose
Treatment
Start
2022-10-26
Primary completion
2029-03
Completion
2029-03
Primary outcomes
  • Number of participants with dose limiting toxicities (DLTs) (Up to 4 months)
  • Number of participants with adverse events (AEs) (Up to 4 months)

NCT05536141 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

How to read these records: evidence · methodology · all trials