Study of Olverembatinib (HQP1351) in Patients With CP-CML

Launched by ASCENTAGE PHARMA GROUP INC. · May 16, 2024

Keywords

ClinConnect Summary

This clinical trial, called POLARIS-2, is studying a new medication called Olverembatinib (HQP1351) to see how well it works for patients with Chronic Myeloid Leukemia (CML) in the chronic phase. The trial is open to adults aged 18 and older who have previously been treated with at least two other approved treatments for CML and have a specific genetic mutation known as T315I. Participants must also be in reasonably good overall health, as determined by a simple performance status scale.

If you or a loved one is eligible and decides to join the trial, you will receive the study medication and will be closely monitored by healthcare professionals. The trial is currently recruiting participants from various locations around the world. It's important to note that individuals who are pregnant, nursing, or have certain health issues may not be eligible to participate. This study aims to provide more options for people living with CML, especially those who have not responded to other treatments.

Gender

ALL

Eligibility 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 Part B: T315I mutation at screening.
• • 4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2.
• • 5. Written informed consent obtained prior to any screening procedures.
• • 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 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.