Ascentage Pharma Group International ((HK:6855)) announced an update on their ongoing clinical study.
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Study Overview: Ascentage Pharma Group International is conducting a Phase I study titled ‘A Phase I Study to Assess the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Properties of Oral HQP1351 in Patients With GIST or Other Solid Tumors.’ The study aims to determine the recommended Phase 2 dose (RP2D) and evaluate the pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of HQP1351 in patients with Gastrointestinal Stromal Tumor (GIST) or other solid tumors. This study is significant as it explores a new treatment option for these conditions.
Intervention/Treatment: The intervention being tested is HQP1351, an oral drug administered once every other day (QOD) for four consecutive weeks per cycle. The study includes various dosing cohorts to assess the drug’s safety and efficacy.
Study Design: This is an interventional study with a randomized, parallel assignment model. Patients are allocated to different dose cohorts (20 mg, 30 mg, 40 mg, and 50 mg QOD) based on their weight and age. The primary purpose of the study is treatment, and there is no masking involved.
Study Timeline: The study began on July 1, 2018, and is currently recruiting participants. The last update was submitted on February 26, 2025. These dates are crucial for tracking the study’s progress and ensuring transparency in its development.
Market Implications: The ongoing study of HQP1351 could significantly impact Ascentage Pharma’s stock performance, as positive results may enhance investor confidence and position the company as a leader in developing treatments for GIST and other solid tumors. The study’s progress is closely watched by competitors and investors, given the high stakes in the oncology market.
The study is ongoing, and further details are available on the ClinicalTrials portal.
