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NCT05544019 (SGR1505 in relapsed/refractory B-cell malignancies): BVCT ex-ante prediction vs. reported outcome

On 6 Aug 2024, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 12 Jun 2025 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
NCT05544019
Drug Name
SGR1505
Drug MoA
allosteric MALT1 inhibitor
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
relapsed/refractory B-cell malignancies
Human Patients
52
Sponsor
Schrödinger
Phase
Phase 1

Prediction of , index 1722

Prospective Prediction
Prediction Index
1722
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient (additive) clinical benefit in OS)
Technical Prediction
SUCCESS (statistically significant (additive) clinical benefit in ORR/PFS)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
310 days in advance
Readout Data Interpretation
SGR1505 achieved a 22% ORR for median 4L+ patients
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
A Phase 1, Open-Label, Multicenter, Dose Escalation Study of SGR-1505 as Monotherapy in Subjects With Mature B-Cell Malignancies
Phase
Phase 1
Status
Recruiting
Enrollment
98
Lead sponsor
Schrödinger, Inc.
Conditions
Mature B-Cell Neoplasm; Non Hodgkin Lymphoma; DLBCL; Waldenstrom Macroglobulinemia; MALT Lymphoma; Follicular Lymphoma; Pediatric-Type Follicular Lymphoma; IRF4 Gene Rearrangement; EBV-Positive DLBCL, Nos; Burkitt Lymphoma; Plasmablastic Lymphoma; High-grade B-cell Lymphoma; Primary Cutaneous Follicle Center Lymphoma; Primary Effusion Lymphoma; Mantle Cell Lymphoma; DLBCL Germinal Center B-Cell Type; Primary Mediastinal Large B Cell Lymphoma; T-Cell/Histiocyte Rich Lymphoma; ALK-Positive Large B-Cell Lymphoma; Primary Cutaneous Diffuse Large B-Cell Lymphoma; Splenic Marginal Zone Lymphoma; Chronic Lymphocytic Leukemia; Nodal Marginal Zone Lymphoma; HHV8-Positive DLBCL, Nos; Lymphoplasmacytic Lymphoma; Duodenal-Type Follicular Lymphoma
Interventions
DRUG: SGR-1505
Design
Non randomized · Sequential · None
Primary purpose
Treatment
Start
2023-04-10
Primary completion
2027-11
Completion
2027-11
Primary outcomes
  • Nature, severity, and number of incidences of adverse events (AEs), serious AEs (SAEs), and AEs leading to treatment discontinuation. (Throughout the study, up to 2 years.)
  • Nature and number of incidences of dose limiting toxicity (DLT). (The first 21 days.)

NCT05544019 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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