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NCT06265727 (CRB701 in 2L treatment for nectin4-overexpressing advanced solid…): BVCT ex-ante prediction vs. reported outcome

On 19 Oct 2024, BioinvestGPT's BVCT predicted technical success and commercial partial success for this trial. The 14 Feb 2025 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant (in ORR non-superior non-inferior to EV) and commercially TBD (wait for OS data).

Clinical Trial

NCTID
NCT06265727
Drug Name
CRB701
Drug MoA
anti-nectin4
Drug Modality
ADC
Drug Class
Best-In-Class
Therapeutic Area
Neoplasms
Indication
2L treatment for nectin4-overexpressing advanced solid tumors
Human Patients
420
Sponsor
Corbus Pharmaceuticals
Phase
Phase 1 Phase 2

Prediction of , index 1803

Prospective Prediction
Prediction Index
1803
Prediction Date
Commercial Prediction
partial SUCCESS (commercially maybe sufficient clinical benefit in OS non-inferior-non-superior to enfortumab vedotin in 2L/3L clinical setting for nectin4-overexpressing advance solid tumors that don’t have FDA-approved drugs)
Technical Prediction
SUCCESS (statistically significant clinical benefit in ORR/PFS in 2L/3L clinical setting non-inferior-non-superior to enfortumab vedotin for nectin4-overexpressing advance solid tumors)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
118 days in advance
Readout Data Interpretation
CRB701 monotherapy achieved 44% ORR as 2L treatment for mUC patients previously treated with enfortumab vedotin (EV); comparable to EV monotherapy that achieve 37.5%-46.8% ORR as 2L treatment for mUC patients previously treated with chemo + anti-PD1 therapies (see add'l link below and DOI-10.1007/s00432-024-05717-2)
Press Release
Additional Readout Data
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant (in ORR non-superior non-inferior to EV) 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 1/2 Study to Investigate the Safety, Pharmacokinetics, and Efficacy of CRB-701, an Antibody-drug Conjugate Targeting Nectin-4, in Patients With Advanced Solid Tumors
Phase
Phase 1, Phase 2
Status
Recruiting
Enrollment
348
Lead sponsor
Corbus Pharmaceuticals Inc.
Conditions
Solid Tumor, Adult
Interventions
DRUG: CRB-701; DRUG: Anti-PD-1
Design
Randomized · Sequential · None
Primary purpose
Treatment
Start
2024-04-01
Primary completion
2027-01-16
Completion
2027-01-27
Primary outcomes
  • Part A: To confirm the safety and tolerability and determine MTD and PADR for CRB-701 (21 days)
  • Part B & C: To evaluate efficacy in terms of Objective Response Rate (ORR) (Up to 6 months)

NCT06265727 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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