臨床研究等提出・公開システム

Date of registration	June. 09, 2026
Last modified on	June. 10, 2026
Trial ID	jRCT2051260072

Scientific Title	A Global Multicenter, Open Label, Randomized, Phase 3 Registrational Study of Olverembatinib (HQP1351) in Patients with Chronic Phase Chronic Myeloid Leukemia (POLARIS-2)
Public Title	Study of Olverembatinib (HQP1351) in Patients With CP-CML (POLARIS-2)

Contact for Scientific Queries	Name	IQVIA Services Japan G.K. jRCT Inquiry Receipt Center
	Affiliation	IQVIA Services Japan G.K.
	Address	Keikyu Dai-1 Building 4-10-18 Takanawa, Minato-ku, Tokyo
	Telephone	+81-3-6859-9500
	E-mail	kei.kutsuzawa@iqvia.com
Contact for Public Queries	Name	IQVIA Services Japan G.K. jRCT Inquiry Contact
	Affiliation	IQVIA Services Japan G.K.
	Address	Keikyu Dai-1 Building 4-10-18 Takanawa, Minato-ku, Tokyo
	Telephone	+81-3-6859-9500
	E-mail	kei.kutsuzawa@iqvia.com

Recruitment status	Recruiting

Anticipated date of first enrollment		June. 09, 2026
Target sample size		333
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	open(masking not used)
	control	active control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Patients eligible for inclusion in this study must meet all of the following criteria. 1. Age >= 18 years old 2. Diagnosis of CML-CP 3. Part A: Previously treated with at least two approved TKIs 4. Part B: T315I mutation at screening and previously treated with at least one approved TKI, with no other effective and/or tolerable therapies available 5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) <= 2 6. Patients with adequate organ functions
	Exclusion Criteria	Patients eligible for this study must not meet any of the following criteria. 1. For Part A only: T315I or V299L mutation at any time prior to starting study treatment. 2. Active infection that requires systemic drug therapy 3. Impairment of gastrointestinal (GI) function or GI disease that may significantly alter absorption of study drugs 4. Previous treatment with or known / suspected hypersensitivity to olverembatinib or any of its excipients. 5. Previous treatment with or known / suspected hypersensitivity to bosutinib or any of its excipients. 6. Pregnant or nursing (lactating) women.
	Age Minimum	18age old over
	Age Maximum	99age old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		CP-CML
Intervention(s)		Part A Drug: olverembatinib olverembatinib QOD Drug: Bosutinib Bosutnib QD Part B Drug: olverembatinib olverembatinib QOD
Primary Outcome(s)		MMR rate Part A: To compare the major molecular response (MMR) rate at 24 weeks of olverembatinib versus bosutinib MMR rate Part B: To evaluate the MMR rate by 24 weeks of olverembatinib in CML-CP patients with T315I mutation

Primary Sponsor	Ascentage Pharma Group Inc.

Secondary Sponsor

Secondary Sponsor

Name of Certified Review Board	University Hospital, Kyoto Prefectural University of Medicine Institutional Review Board
Address	465 Kajii-cho Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto
Telephone	+81-75-251-5111
E-Mail	chikenjm@koto.kpu-m.ac.jp
Approval Status	Approval
Date of approval	Feb. 05, 2026

Plan to share IPD	No

Secondary ID(s)	NCT06423911
Issuing Authority	ClinicalTrials.gov

Countries of Recruitment（Except Japan）	United States/ Canada/Spain/India/Poland/Australia/Russia/Italy/United Kingdom/South Korea/Singapore/Belgium/France/Germany/Taiwan (China)/Hong Kong (China)/Turkey/Brazil/Mexico

History of Changes

No	Publication date
2	June. 10, 2026	(this page)	Changes
1	June. 09, 2026	Detail

List of change history