Clinical trial · Interventional
KRT-232 and TKI Study in Chronic Myeloid Leukemia
An Open-Label, Multicenter, Phase 1b/2 Study of the Safety and Efficacy of KRT-232 Combined With a Tyrosine Kinase Inhibitor (TKI) in Patients With Relapsed or Refractory Ph+ Chronic Myeloid Leukemia (CML)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study evaluates KRT-232, a novel oral small molecule inhibitor of MDM2, for the treatment of patients with Ph+ Chronic Myeloid Leukemia (CML) who have relapsed or are refractory or intolerant to a Tyrosine Kinase Inhibitor (TKI). This study is a global, open label Phase 1b/2 to determine the efficacy and safety of KRT-232 in patients with chronic phase CML (CML-CP) and accelerated phase (CML-AP) who have failed TKI treatments.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Myeloid Leukemia | Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dasatinib | Drug | Dasatinib | ALIAS |
| KRT-232 | Drug | Navtemadlin | ALIAS |
| Nilotinib | Drug | Nilotinib | ALIAS |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Part 1, KRT-232 combined with TKI (Dasatinib or Nilotinib) in patients with CML-CP
- description
- KRT-232 will be administered orally, once daily (QD) on Days 1-7 in a 28-day cycle. TKI (dasatinib or nilotinib) will be administered orally, per locally prescribed dose and schedule.
- interventionNames
- Drug: KRT-232
- Drug: Dasatinib
- Drug: Nilotinib
- type
- EXPERIMENTAL
- label
- Part 2, Arm A (KRT-232 combined with Dasatinib in patients with CML-CP)
- description
- KRT-232 will be administered orally, once daily (QD) on Days 1-7 in a 28-day cycle. Dasastinib will be administered orally, per locally prescribed dose and schedule.
- interventionNames
- Drug: KRT-232
- Drug: Dasatinib
- type
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Phase 1b and Phase 2 Arms A and B: Documented TP53wt, Ph+, BCR-ABL+ CML-CP * Phase 2 Arm C ONLY: Documented TP53wt, Ph+, BCR-ABL+ CML-AP * Subject is resistant (relapsed or refractory) and/or intolerant to at least 1 prior TKI. * Adults ≥ 18 years of age. * ECOG performance status of 0 to 2 * Adequate hematologic, hepatic, and renal functions Exclusion Criteria: * Phase 1b and Phase 2 Arms A and B: Documented Ph+, BCR-ABL+ CML-AP * Documented Ph+, BCR-ABL+ CML-BC * Known T315I mutation. * Prior treatment with MDM2 antagonist therapies. * Intolerance to current TKI therapy.
References
Publications (0)
Data not yet available