BioinvestGPT

BioinvestGPT ApS · Research use only

NCT05775406 (KT-253 in relapsed or refractory high grade myeloid…): BVCT ex-ante prediction vs. reported outcome

On 14 Aug 2023, BioinvestGPT's BVCT predicted technical failure and commercial failure for this trial. The 23 May 2024 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially insufficient.

Clinical Trial

NCTID
NCT05775406
Drug Name
KT-253
Drug MoA
MDM degrader
Drug Modality
small molecule
Drug Class
Best-In-Class
Therapeutic Area
Neoplasms
Indication
relapsed or refractory (R/R) high grade myeloid malignancies; acute lymphocytic leukemia (ALL); R/R lymphoma; and R/R solid tumors
Human Patients
70
Sponsor
Kymera Therapeutics
Phase
Phase 1

Prediction of , index 1122

Prospective Prediction
Prediction Index
1122
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit in OS inferior to SoC)
Technical Prediction
FAILURE (statistically maybe significant yet very weak clinical benefit in ORR/PFS)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
283 days in advance
Readout Data Interpretation
15.8% ORR far lower than 40% ORR by SoC (doi- 10.1177/2040620720955006).
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially insufficient
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

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

Official title
A Phase 1, Multicenter, Open-Label, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of Intravenously Administered KT-253 in Adult Patients with High Grade Myeloid Malignancies and Acute Lymphocytic Leukemia, Lymphoma, and Advanced Solid Tumors
Phase
Phase 1
Status
Completed
Enrollment
52
Lead sponsor
Kymera Therapeutics, Inc.
Conditions
Myeloid Malignancies; Acute Lymphocytic Leukemia; Lymphomas; Advanced Solid Tumors
Interventions
DRUG: KT-253
Design
Non randomized · Sequential · None
Primary purpose
Treatment
Start
2023-05-15
Primary completion
2024-12-18
Completion
2024-12-18
Primary outcomes
  • Incidence and severity of adverse events (From the time of signing ICF through 30 days after last dose of study drug or prior to start of a new anticancer therapy)
  • Maximum Tolerated Dose (MTD) and recommended Phase 2 dose (RP2D) in Patients (From the time of the first dose of study drug through 30 days after the last dose of study drug or prior to start of a new anticancer therapy)

NCT05775406 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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