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NCT06299761 (BBI-825 in advanced solid tumours with resistance oncogene…): BVCT ex-ante prediction vs. reported outcome

On 29 Aug 2024, BioinvestGPT's BVCT predicted technical failure and commercial failure for this trial. The 12 Dec 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
NCT06299761
Acronym
STARMAP
Drug Name
BBI-825
Drug MoA
RNR inhibitor
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
advanced solid tumours with resistance oncogene amplifications
Human Patients
42
Sponsor
Boundless Bio
Phase
Phase 1

Prediction of , index 1770

Prospective Prediction
Prediction Index
1770
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit in OS)
Technical Prediction
FAILURE (statistically insignificant clinical benefit in ORR/PFS)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
105 days in advance
Readout Data Interpretation
BBI825’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
An Open-Label, Multicenter, First-in-Human, Dose-Escalation and Dose-Expansion, Phase 1/2 Study of BBI-825 and BBI-825 in Combination With Select Targeted Therapies in Subjects With Locally Advanced or Metastatic Solid Tumors With Resistance Gene Amplifications
Phase
Phase 1
Status
Terminated
Enrollment
19
Lead sponsor
Boundless Bio, Inc.
Conditions
Solid Tumor
Interventions
DRUG: BBI-825
Design
Sequential · None
Primary purpose
Treatment
Start
2024-03-28
Primary completion
2025-06-25
Completion
2025-06-25
Primary outcomes
  • Frequency and severity of treatment emergent adverse events (TEAEs) of BBI-825 (Start of Cycle 1 until 30 days following last dose (each cycle is 28 days))
  • Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of BBI-825 (Start of Cycle 1 until 30 days following last dose (each cycle is 28 days))

NCT06299761 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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