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NCT05551117 (Vobramitamab Duocarmazine in Metastatic Castration Resistant Prostate Cancer): BVCT ex-ante prediction vs. reported outcome

On 3 Mar 2024, BioinvestGPT's BVCT predicted technical partial success and commercial failure for this trial. The 9 May 2024 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: commercially insufficient due to weak efficacy and high toxicity..

Clinical Trial

NCTID
NCT05551117
Acronym
Tamarack
Drug Name
Vobramitamab Duocarmazine
Drug MoA
anti-B7-H3 ADC with DUBA payload for lysosomal-protease-cleavage-mediated intracellular release
Drug Modality
ADC
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
Metastatic Castration Resistant Prostate Cancer
Human Patients
382
Sponsor
MacroGenics
Phase
Phase 2

Prediction of , index 812

Prospective Prediction
Prediction Index
812
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit)
Technical Prediction
partial SUCCESS (statistically maybe significant yet weak clinical benefit with high toxicity)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
67 days in advance
Readout Data Interpretation
25% ORR (vs 30% ORR for 177Lu-PSMA-617 + SoC in the same setting of 2L mCRPC in phase 3); 93%-95% TEAEs.
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
commercially insufficient due to weak efficacy and high toxicity.
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

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

Official title
A Phase 2, Open-label, Study of Vobramitamab Duocarmazine in Participants With Metastatic Castration-resistant Prostate Cancer and Other Solid Tumors
Phase
Phase 2
Status
Terminated
Enrollment
192
Lead sponsor
MacroGenics
Conditions
Castration-Resistant Prostatic Cancer; Androgen-Independent Prostatic Cancer; Androgen-Insensitive Prostatic Cancer; Androgen-Resistant Prostatic Cancer; Hormone Refractory Prostatic Cancer; Anal Cancer; Anal Neoplasm; Carcinoma, Squamous Cell of Head and Neck; Head and Neck Squamous Cell Carcinoma; Laryngeal Squamous Cell Carcinoma; Oral Squamous Cell Carcinoma; Malignant Melanoma; Melanoma; Non-small Cell Lung Cancer; Non-small Cell Carcinoma; Small-cell Lung Cancer; Small Cell Carcinoma
Interventions
BIOLOGICAL: vobramitamab duocarmazine 2.0 mg (Arm A); BIOLOGICAL: vobramitamab duocarmazine 2.7 mg (Arm B); BIOLOGICAL: vobramitamab duocarmazine; DRUG: Abiraterone; DRUG: Enzalutamide
Design
Randomized · Parallel · None
Primary purpose
Treatment
Start
2023-06-13
Primary completion
2024-07-04
Completion
2025-01-23
Results first posted
2026-02-09
Primary outcomes
  • Part 1: Six-month Radiographic Progression Free Survival (rPFS) as Determined by the Investigator (Assessed every 8 weeks for six months. Six month data reported.)
  • Part 2: Objective Response Rate (ORR) Per Investigator Assessment of Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 Criteria (Every 8 weeks for the first 24 weeks, then every 12 weeks. Average duration of participation, 10 months.)

NCT05551117 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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