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NCT03698552 (ADCT-602 in Recurrent or Refractory B-cell Acute Lymphoblastic…): BVCT ex-ante prediction vs. reported outcome

On 9 Sep 2024, BioinvestGPT's BVCT predicted technical success and commercial failure for this trial. The 14 May 2025 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
NCT03698552
Drug Name
ADCT-602
Drug MoA
anti-CD22 ADC conjugated with a PBD-dimer cytotoxin SG3249
Drug Modality
ADC
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
Recurrent or Refractory B-cell Acute Lymphoblastic Leukemia (ALL)
Human Patients
57
Sponsor
ADC Therapeutics
Phase
Phase 1 Phase 2

Prediction of , index 1781

Prospective Prediction
Prediction Index
1781
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit in OS non-superior non-inferior to inotuzumab ozogamicin)
Technical Prediction
SUCCESS (statistically significant clinical benefit in CR/CRi/ORR/PFS against placebo yet non-superior non-inferior to inotuzumab ozogamicin)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
247 days in advance
Readout Data Interpretation
ADCT602’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 I/II Study to Evaluate the Safety and Anti-Tumor Activity of ADCT-602 Targeting CD22 in Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia
Phase
Phase 1, Phase 2
Status
Terminated
Enrollment
37
Lead sponsor
M.D. Anderson Cancer Center
Conditions
Blasts 5 Percent or More of Bone Marrow Nucleated Cells; CD22 Positive; Philadelphia Chromosome Positive; Recurrent B Acute Lymphoblastic Leukemia; Refractory B Acute Lymphoblastic Leukemia
Interventions
BIOLOGICAL: ADCT-602
Design
Single group · None
Primary purpose
Treatment
Start
2018-08-24
Primary completion
2025-11-06
Completion
2025-11-06
Primary outcomes
  • Maximum tolerated dose (MTD) as determined by dose limiting toxicities (DLTs) (Phase I) (Up to 21 days)
  • Incidence of toxicity graded according to Common Terminology Criteria for Adverse Events (CTCAE) (Up to 1 year)
  • Recommended phase II dose of ADCT-602 (Up to 21 days)
  • Complete response (CR)/ CR with incomplete marrow recovery (CR/CRi) rate (Phase II) (Up to 1 year)

NCT03698552 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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