OncoMatch/Clinical Trials/NCT05367700
A Study of HS-10382 in Patients With Chronic Myeloid Leukemia.
Is NCT05367700 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1 trial studies multiple treatments including HS-10382(Part 1: Dose escalation) and HS-10382(Part 2: Dose expansion) for cml, chronic phase.
Treatment: HS-10382(Part 1: Dose escalation) · HS-10382(Part 2: Dose expansion) — HS-10382 is a small molecular, oral potent, allosteric inhibitor. By binding a myristoyl site of the BCR-ABL1 protein, HS-10382 locks BCR-ABL1 into an inactive conformation. The purpose of this study is to investigate the safety/tolerability and the pharmacokinetic(PK) profile of HS-10382 in patients with chronic myeloid leukemia (CML). Anti-CML activity will also be investigated in this study.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Chronic Myeloid Leukemia
Biomarker criteria
Required: ABL1 fusion
Required: BCR fusion
Disease stage
Required: Stage CHRONIC PHASE, ACCELERATED PHASE
Excluded: Stage BLAST PHASE
CML-CP/AP patients
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
Prior therapy
Must have received: BCR-ABL inhibitor
resistant to or intolerant to previous TKIs therapy
Cannot have received: BCR-ABL1 TKI allosteric inhibitor
Previous treatment with a BCR-ABL1 TKI allosteric inhibitor
Lab requirements
Cardiac function
No impaired cardiac function including: QTc > 470 ms, clinically important ECG abnormalities, risk factors for QTc prolongation or arrhythmia, LVEF ≤ 50%, average heart rate <50 bpm, recent MI or CHF (within 6 months), uncontrollable angina.
Impaired cardiac function including any one of the following: Resting corrected QT interval (QTc) > 470 ms... LVEF ≤ 50%... MI or CHF within 6 months... uncontrollable angina.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT05367700 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior BCR-ABL1 TKI allosteric inhibitor disqualifies patients from enrollment.
Does this trial require ABL1?
Yes, ABL1 fusion is a required biomarker for enrollment.
Does this trial require BCR?
Yes, BCR fusion is a required biomarker for enrollment.
What disease stage is eligible?
Stage CHRONIC PHASE or ACCELERATED PHASE is required.
Is there an age limit?
Yes. Patients must be 74 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify