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NCT05275439 (SL-172154 in Acute Myeloid Leukemia / Myelodysplastic Syndrome): BVCT ex-ante prediction vs. reported outcome

On 25 Jun 2023, BioinvestGPT's BVCT predicted technical failure and commercial failure for this trial. The 14 Jun 2024 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: no additive efficacy compared with SoC 1L; thus commercially insufficient.

Clinical Trial

NCTID
NCT05275439
Drug Name
SL-172154
Drug MoA
CD47-CD40 fusion protein
Drug Modality
fusion protein biologic
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
Acute Myeloid Leukemia (AML) / Myelodysplastic Syndrome (MDS)
Human Patients
160
Sponsor
Shattuck Labs
Phase
Phase 1

Prediction of , index 614

Prospective Prediction
Prediction Index
614
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient additive clinical benefit)
Technical Prediction
FAILURE (statistically insignificant additive clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
355 days in advance
Readout Data Interpretation
67% ORR (MDS vs 73% ORR and 73% CR/mCR for azacitidine) and 43% ORR (AML; vs 69% ORR and 45% CR for a azacitidine + magrolimab as 1L for TP53 mutant AML).
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
no additive efficacy compared with SoC 1L; thus commercially 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 1a/1b Dose Escalation and Expansion Cohort Study of SL-172154 (SIRPα-Fc-CD40L) in Combination With Azacitidine or With Azacitidine and Venetoclax for the Treatment of Subjects With Higher-Risk Myelodysplastic Syndrome (MDS) or Acute Myeloid Leukemia (AML)
Phase
Phase 1
Status
Terminated
Enrollment
106
Lead sponsor
Shattuck Labs, Inc.
Conditions
Acute Myeloid Leukemia; Myelodysplastic Syndromes
Interventions
DRUG: SL-172154; DRUG: Azacitidine (AZA); DRUG: Venetoclax
Design
Non randomized · Sequential · None
Primary purpose
Treatment
Start
2022-03-17
Primary completion
2025-02-06
Completion
2025-02-06
Results first posted
2026-03-18
Primary outcomes
  • Safety Profile of SL-172154 Monotherapy or in Combination With Azacitidine (From Day 1 to study completion, an average of 2-5 months depending on the treatment arm)
  • Recommended Phase 2 Dose of SL-172154 Administered With Azacitidine (From Day 1 to study completion, an average of 2-5 months depending on the treatment arm)
  • Safety Profile of SL-172154 in Combination With Azacitidine or Azacitidine Monotherapy (From Day 1 to study completion, an average of 2-5 months depending on the treatment arm)

NCT05275439 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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