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NCT05389462 (Mipasetamab Uzoptirine in advanced solid tumours): BVCT ex-ante prediction vs. reported outcome

On 9 Sep 2024, BioinvestGPT's BVCT predicted technical partial success and commercial failure for this trial. The 7 Nov 2024 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically probably insignificant and commercially probably insufficient.

Clinical Trial

NCTID
NCT05389462
Drug Name
Mipasetamab Uzoptirine (ADCT-601)
Drug MoA
anti-AXL ADC conjugated with a PBD-dimer cytotoxin SG3199
Drug Modality
ADC
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
advanced solid tumours
Human Patients
128
Sponsor
ADC Therapeutics
Phase
Phase 1

Prediction of , index 1780

Prospective Prediction
Prediction Index
1780
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient additive clinical benefit in OS for advanced solid tumors regardless of AXL amplification status in 2L/3L clinical settings) partial FAILURE (commercially maybe sufficient yet very weak clinical benefit in OS at most numerically superior to chemotherapy for advanced solid tumors with AXL amplification in 2L/3L clinical settings)
Technical Prediction
partial SUCCESS (statistically maybe significant yet weak additive clinical benefit in ORR/PFS for advanced solid tumors regardless of AXL amplification status in 2L/3L clinical settings) SUCCESS (statistically significant clinical benefit in ORR/PFS superior to chemotherapy for advanced solid tumors with AXL amplification in 2L/3L clinical settings)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
59 days in advance
Readout Data Interpretation
ADCT601’s further development has been discontinued due to insufficient benefit-risk profile
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically probably insignificant and commercially probably insufficient
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

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

Official title
A Phase 1b, Open-Label, Dose-Escalation and Dose-Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of Mipasetamab Uzoptirine (ADCT-601) Monotherapy and in Combination With Other Anti-Cancer Therapies in Patients With Selected Advanced Solid Tumors
Phase
Phase 1
Status
Terminated
Enrollment
128
Lead sponsor
ADC Therapeutics S.A.
Conditions
Advanced Solid Tumors
Interventions
DRUG: ADCT-601; DRUG: Gemcitabine
Design
Non randomized · Sequential · None
Primary purpose
Treatment
Start
2022-07-13
Primary completion
2025-04-17
Completion
2025-04-17
Primary outcomes
  • Safety and Tolerability as Assessed by Number of Participants with Adverse Events (AEs) (Up to approximately 2 years)
  • Number of Participants who Experience a Dose Limiting Toxicity (DLT) (Day 1 to Day 21)
  • Number of Participants who Experience a Dose Interruption (Up to approximately 2 years)
  • Number of Participants who Experience a Dose Reduction (Up to approximately 2 years)

NCT05389462 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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