NCT05367700 is a Phase 1 clinical trial of HS-10382(Part 1: Dose escalation) in CML, Chronic Phase, sponsored by Jiangsu Hansoh Pharmaceutical Co., Ltd..

Who is sponsoring NCT05367700?

NCT05367700 is sponsored by Jiangsu Hansoh Pharmaceutical Co., Ltd..

What drugs are being tested in NCT05367700?

Interventions in NCT05367700: HS-10382(Part 1: Dose escalation), HS-10382(Part 2: Dose expansion).

What condition does NCT05367700 study?

NCT05367700 studies CML, Chronic Phase, CML, Accelerated Phase.

Is NCT05367700 still recruiting?

NCT05367700 is currently recruiting now. Last updated 13 January 2023.

Last reviewed 2023-01-13 · How we verify

NCT05367700

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study of HS-10382 in Patients With Chronic Myeloid Leukemia.

Recruiting now Phase 1 Last updated 13 January 2023

What this trial tests

Phase 1 trial testing HS-10382(Part 1: Dose escalation) in CML, Chronic Phase in 108 participants. Currently enrolling.

Timeline

28 April 2022

Primary endpoint
30 December 2024

30 September 2026

Quick facts

Lead sponsor	Jiangsu Hansoh Pharmaceutical Co., Ltd.
Phase	Phase 1
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	108
Start date	28 April 2022
Primary completion	30 December 2024
Estimated completion	30 September 2026
Sites	1 location across China

Drugs / interventions tested

HS-10382(Part 1: Dose escalation) — full drug profile →
HS-10382(Part 2: Dose expansion) — full drug profile →

Conditions studied

CML, Chronic Phase — all drugs for CML, Chronic Phase →
CML, Accelerated Phase — all drugs for CML, Accelerated Phase →

Sponsor

Jiangsu Hansoh Pharmaceutical Co., Ltd. — full company profile →

Who can join

Adults 18 to 74, any sex, with CML, Chronic Phase or CML, Accelerated Phase. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Exploring treatment decision-making in chronic myeloid leukemia in chronic phase.
Andorsky D, Kota V, Sweet K. · · 2024 · cited 4× · PMID 39011484 · DOI 10.3389/fonc.2024.1369246
STAMP inhibitors and their future in CML therapy: a critical analysis.
Yildiz D, Eskazan AE. · · 2025 · PMID 41120306 · DOI 10.1038/s41408-025-01378-7
PB1971: A PHASE 1 MULTICENTER OPEN-LABEL DOSE-ESCALATION AND DOSE-EXPANSION STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, EFFICACY OF HS-10382 (TERN-70) IN CHRONIC MYELOID LEUKEMIA PATIENTS
LI W, Xu N, Xu Z, Zhang Y, et al · · 2023

Verify or expand the search:

Other recruiting trials for CML, Chronic Phase

Currently open trials in the same condition.

NCT03459534 — A Phase 3 Study for the Efficacy and Safety of Radotinib in CP-CML Patients With Failure or Intolerance to Previous TKIs · Phase 3 · recruiting

Other Jiangsu Hansoh Pharmaceutical Co., Ltd. trials

Trials by the same sponsor.

NCT07468851 — A Study of HS-10566 in Patients With High-risk Non-muscle-invasive Bladder Cancer Who Are Ineligible for or Refuse Radic · Phase 1, PHASE2 · not yet recruiting
NCT07483437 — A Study of HS-20136-2 in Healthy Participants · Phase 1 · not yet recruiting
NCT07535970 — A Phase I Study to Evaluate the Effect of Itraconazole on the Pharmacokinetics of HS-10506 in Healthy Chinese Adult Part · Phase 1 · not yet recruiting
NCT07503015 — Phase 1 Study of HS-20152 in Healthy Participants · Phase 1 · not yet recruiting
NCT07414953 — A Phase Ib Study of HS-10504 Combined Therapy in NSCLC · Phase 1 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05367700 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Jiangsu Hansoh Pharmaceutical Co., Ltd.
Last refreshed: 13 January 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05367700.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing