BioinvestGPT

BioinvestGPT ApS · Research use only

NCT05308264 (R906289 Monosodium in R/R Lower-risk Myelodysplastic Syndromes that have…): BVCT ex-ante prediction vs. reported outcome

On 15 Apr 2024, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 9 Dec 2024 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially TBD (wait for OS data).

Clinical Trial

NCTID
NCT05308264
Drug Name
R906289 Monosodium (R289 Na)
Drug MoA
IRAK1/IRAK4 inhibitor
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
R/R Lower-risk Myelodysplastic Syndromes (LR MDS) that have exhausted all the other treatment options
Human Patients
34
Sponsor
Rigel Pharmaceuticals
Phase
Phase 1 Phase 2

Prediction of , index 1550

Prospective Prediction
Prediction Index
1550
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient clinical benefit)
Technical Prediction
SUCCESS (statistically significant clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
238 days in advance
Readout Data Interpretation
R289 achieved 40% hematologic responses (4/10 ≥500 mg QD) and 30% RBC-TI (3/10 ≥500 mg QD) for 8 week and 1 Grade3 AST/Grade4 ALT TEAE
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially TBD (wait for OS data)
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

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

Official title
An Open-label, Phase 1b Study of R289, an IRAK1/4 Inhibitor, in Patients With Lower-risk Myelodysplastic Syndromes (LR MDS) Who Are Relapsed/Refractory/Resistant to Prior Therapies
Phase
Phase 1, Phase 2
Status
Recruiting
Enrollment
86
Lead sponsor
Rigel Pharmaceuticals
Conditions
Low Risk Myelodysplastic Syndromes
Interventions
DRUG: R906289 Monosodium (R289 Na)
Design
Sequential · None
Primary purpose
Treatment
Start
2022-09-12
Primary completion
2026-08
Completion
2026-12
Primary outcomes
  • Safety and Tolerability (2 Year)

NCT05308264 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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