NCT04126707 is a Phase 1 clinical trial of [14C] HQP1351 in Chronic Myeloid Leukemia (CML), sponsored by Ascentage Pharma Group Inc..

Who is sponsoring NCT04126707?

NCT04126707 is sponsored by Ascentage Pharma Group Inc..

What drugs are being tested in NCT04126707?

Interventions in NCT04126707: [14C] HQP1351.

What condition does NCT04126707 study?

NCT04126707 studies Chronic Myeloid Leukemia (CML).

Is NCT04126707 still recruiting?

NCT04126707 is currently completed. Last updated 8 September 2021.

Last reviewed 2021-09-08 · How we verify

NCT04126707

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

The Absorption, Metabolism and Excretion of [14C] HQP1351 in Humans

Completed Phase 1 Last updated 8 September 2021

What this trial tests

Phase 1 trial testing [14C] HQP1351 in Chronic Myeloid Leukemia (CML) in 6 participants. Completed in 13 January 2020.

Timeline

19 November 2019

Primary endpoint
13 January 2020

13 January 2020

Quick facts

Lead sponsor	Ascentage Pharma Group Inc.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	6
Start date	19 November 2019
Primary completion	13 January 2020
Estimated completion	13 January 2020
Sites	1 location across China

Drugs / interventions tested

[14C] HQP1351 — full drug profile →

Conditions studied

Chronic Myeloid Leukemia (CML) — all drugs for Chronic Myeloid Leukemia (CML) →

Sponsor

Ascentage Pharma Group Inc. — full company profile →

Who can join

Adults 18 to 50, male only, with Chronic Myeloid Leukemia (CML). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The objective of this study is to determine the mass balance and routes of excretion of total radioactivity after a single oral 30mg (100µCi) dose of \[14C\] HQP1351 given as a suspension. For further clinical development, human mass balance data are required to elucidate the absorption, metabolism, and excretion of HQP1351.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Potential drug-drug interaction of olverembatinib (HQP1351) using physiologically based pharmacokinetic models.
Yu Z, Lei Z, Yao X, Wang H, et al · · 2022 · cited 4× · PMID 36582520 · DOI 10.3389/fphar.2022.1065130

Verify or expand the search:

Other recruiting trials for Chronic Myeloid Leukemia (CML)

Currently open trials in the same condition.

NCT07165535 — Quality of Life and Care Organization of Patients With Chronic Myeloid Leukemia in the Lombardy Hematology Network · recruiting
NCT06514534 — Open-label Study of Asciminib for CML-CP or CML-AP Patients With T315I Mutation Who Are Resistant, Intolerant or Ineligi · Phase 2 · recruiting
NCT05589896 — A First-in-Human Study of HLA-Partially to Fully Matched Allogenic Cryopreserved Deceased Donor Bone Marrow Transplantat · Phase 1, PHASE2 · recruiting
NCT03849651 — TCRαβ-depleted Progenitor Cell Graft With Additional Memory T-cell DLI, Plus Selected Use of Blinatumomab, in Naive T-ce · Phase 2 · active not recruiting
NCT03481868 — EPIgenetics and in Vivo Resistance of Chronic Myeloid Leukemia Stem Cells to Tyrosine Kinase Inhibitors · NA · recruiting

Other Ascentage Pharma Group Inc. trials

Trials by the same sponsor.

NCT07282093 — Pharmacokinetics of Olverembatinib in Participants With Hepatic Impairment · Phase 1 · recruiting
NCT06640361 — A Study of Olverembatinib in SDH-deficient GIST. · Phase 3 · recruiting
NCT06389292 — A Pivotal Study of APG-2575 (Lisaftoclax) Combined With Azacitidine in the Treatment of Acute Myeloid Leukemia · Phase 3 · recruiting
NCT06104566 — Global Trial in APG2575 for Patients With CLL/SLL · Phase 3 · recruiting
NCT06051409 — A Study of Olverembatinib in Patients With Newly Diagnosed Ph+ALL. · Phase 3 · 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 NCT04126707 (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 Ascentage Pharma Group Inc.
Last refreshed: 8 September 2021

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/NCT04126707.

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