Ascentage Pharma Group International ((HK:6855)) announced an update on their ongoing clinical study.
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Ascentage Pharma Group International is conducting a Phase Ib study titled ‘A Phase Ib Study of the Safety, Pharmacokinetic of Lisaftoclax (APG-2575) Single Agent and in Combination With Homoharringtonine or Azacitidine in Patients With Relapsed/Refractory AML.’ The study aims to evaluate the safety and pharmacokinetic profile of Lisaftoclax, both as a standalone treatment and in combination with other therapies, for patients with relapsed or refractory acute myeloid leukemia (AML) and related myeloid malignancies. This research is significant as it explores potential new treatment avenues for challenging AML cases.
The study tests Lisaftoclax (APG-2575), an experimental drug administered orally, alone and in combination with reduced-dose or standard-dose Homoharringtonine (HHT), Azacitidine (AZA), and Olverembatinib. These combinations aim to determine the maximum tolerated dose and recommended phase 2 dose, offering potential new treatment options for AML patients.
The study follows a non-randomized, parallel intervention model without masking, focusing on treatment as its primary purpose. This design allows researchers to directly observe the effects of the drug and its combinations on participants, facilitating a clearer understanding of its safety and efficacy.
The study began on August 3, 2020, with its primary completion and estimated completion dates yet to be announced. The most recent update was submitted on September 23, 2025. These timelines are crucial for investors to track the progress and potential market entry of the drug.
The ongoing study could significantly impact Ascentage Pharma’s stock performance and investor sentiment, as positive results may enhance the company’s competitive position in the oncology market. Investors should also consider the broader industry context, where advancements in AML treatment are highly competitive.
The study is currently recruiting, with further details available on the ClinicalTrials portal.