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NCT05712889 (VIP236 in Advanced Cancer): BVCT ex-ante prediction vs. reported outcome

On 26 Feb 2024, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 8 Apr 2024 readout is classified on the dashboard as False Positive (FP), a missed prediction. Recorded clinical-benefit conclusion: statistically insignificant and commercially insufficient.

Clinical Trial

NCTID
NCT05712889
Drug Name
VIP236
Drug MoA
alpha5beta3-integrin-specific SMDC with NE-cleavage-mediated release of CPT payload
Drug Modality
small molecule drug conjugate (SMDC)
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
Advanced Cancer
Human Patients
24
Sponsor
Vincerx Pharma
Phase
Phase 1

Prediction of , index 1482

Prospective Prediction
Prediction Index
1482
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient clinical benefit)
Technical Prediction
SUCCESS (statistically significant clinical benefit in PFS/OS/ORR)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
42 days in advance
Readout Data Interpretation
safer yet with 0% ORR.
Press Release
Prediction Result
Prediction Accuracy
Missed Prediction
Due to
due to suboptimal modelling of linker that has been permanently corrected
Clinical Benefit Conclusion
statistically insignificant and commercially insufficient
Prediction Classification
False Positive (FP)

ClinicalTrials.gov record

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

Official title
An Open-label, Multicenter Phase 1 Study to Characterize Safety, Tolerability, Preliminary Antitumor Activity and Pharmacokinetics of VIP236 Monotherapy in Subjects With Advanced Cancer
Phase
Phase 1
Status
Completed
Enrollment
29
Lead sponsor
Vincerx Pharma, Inc.
Conditions
Neoplasms
Interventions
DRUG: VIP236 (Q3W); DRUG: VIP236 (Q2W)
Design
Non randomized · Sequential · None
Primary purpose
Treatment
Start
2023-01-24
Primary completion
2024-10-10
Completion
2024-10-10
Primary outcomes
  • Incidence of DLT (Dose limit toxicity) of VIP236 (Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 28 days)
  • Number of participants with adverse events as a measure safety and tolerability (Cycle 1 Day 1 up to 30 days after the last dose, where each cycle is up to 28 days (up to approximately 10 months))

NCT05712889 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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