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NCT06056791 (INKmune in Metastatic Castration Resistant Prostate Cancer): BVCT ex-ante prediction vs. reported outcome

On 21 Aug 2024, BioinvestGPT's BVCT predicted technical partial success and commercial failure for this trial. The 30 Oct 2025 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically probably insignificant (ORR) and commercially probably insufficient.

Clinical Trial

NCTID
NCT06056791
Acronym
CaRe
Drug Name
INKmune
Drug MoA
NK cell activator
Drug Modality
cell therapy
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
Metastatic Castration Resistant Prostate Cancer (mCRPC)
Human Patients
30
Sponsor
Inmune Bio
Phase
Phase 1 Phase 2

Prediction of , index 1301

Prospective Prediction
Prediction Index
1301
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit in OS)
Technical Prediction
partial SUCCESS (statistically maybe significant yet weak clinical benefit in ORR/PFS)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
435 days in advance
Readout Data Interpretation
INKmune has met its primary endpoint and has not met the “reduction in tumour load” secondary endpoint
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically probably insignificant (ORR) and commercially probably insufficient
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

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

Official title
An Open-label, Phase I/IIa Dose Escalation and Expansion Study to Determine the Safety and Clinical Activity of an Immune Priming Cell Therapy (INKmune) in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)
Phase
Phase 1, Phase 2
Status
Completed
Enrollment
12
Lead sponsor
Inmune Bio, Inc.
Conditions
Cancer; Metastatic Castration-resistant Prostate Cancer; mCRPC
Interventions
BIOLOGICAL: INKmune
Design
Non randomized · Sequential · None
Primary purpose
Treatment
Start
2023-11-30
Primary completion
2025-09-10
Completion
2025-09-10
Primary outcomes
  • Determine the optimal concentration of INKmune therapy to be used in patients with mCRPC. (2-3 years)
  • Determine the optimal concentration of INKmune therapy to be used in patients with mCRPC. (2-3 years)
  • Determine the optimal concentration of INKmune therapy to be used in patients with mCRPC. (2-3 years)
  • Determine the optimal concentration of INKmune therapy to be used in patients with mCRPC. (2-3 years)
  • Evaluate the safety and tolerability of INKmune therapy in patients with mCRPC. (2-3 years)

NCT06056791 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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