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NCT05519449 (JANX007 in Metastatic Castration-Resistant Prostate Cancer): BVCT ex-ante prediction vs. reported outcome

On 9 Jul 2024, BioinvestGPT's BVCT predicted technical success and commercial partial failure for this trial. The 2 Dec 2024 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically significant yet weak and commercially TBD (wait for OS data).

Clinical Trial

NCTID
NCT05519449
Acronym
ENGAGER-PSMA-01
Drug Name
JANX007
Drug MoA
anti-PSMA/CD3 protease-activated albumin-binding TCE
Drug Modality
bispecific antibody
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Human Patients
105
Sponsor
Janux Therapeutics
Phase
Phase 1

Prediction of , index 1669

Prospective Prediction
Prediction Index
1669
Prediction Date
Commercial Prediction
partial FAILURE (commercially insufficient clinical benefit in ORR/PFS/rPFS inferior to Pluvicto) partial SUCCESS (commercially maybe sufficient yet weak clinical benefit in OS maybe superior to Pluvicto)
Technical Prediction
SUCCESS (statistically significant yet weak clinical benefit in ORR/PFS/rPFS against placebo)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
146 days in advance
Readout Data Interpretation
JANX007 achieved 7.4 months PFS (median 5L); which is inferior to 8.5months PFS achieved by Lu-117-PSMA-617 + SoC (median 3L); JANX007 probably achieved 25% confirmed ORR (2/8; inferred from the reported 50% ORR that glossed over the number of confirmed and unconfirmed responses); which is inferior to 30% ORR achieved by Lu-117-PSMA-617 + SoC (median 3L)
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant yet weak and commercially TBD (wait for OS data)
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

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

Official title
A Phase 1, Open-Label, Multicenter Study of JANX007 in Subjects With Metastatic Castration-Resistant Prostate Cancer
Phase
Phase 1
Status
Recruiting
Enrollment
272
Lead sponsor
Janux Therapeutics
Conditions
Prostate Cancer; Metastatic Castration-resistant Prostate Cancer; Castration Resistant Prostatic Cancer
Interventions
BIOLOGICAL: JANX007; DRUG: Darolutamide
Design
Non randomized · Sequential · None
Primary purpose
Treatment
Start
2022-09-15
Primary completion
2027-07
Completion
2028-12
Primary outcomes
  • Incidence of Dose Limiting Toxicities (DLT) (3 years)
  • Incidence of Adverse Events (AE) and Serious Adverse Events (SAE) (3 years)

NCT05519449 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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