Trials
Search / Trial NCT06423911

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

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

Trial Information

Current as of February 18, 2025

Recruiting

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.

About Ascentage Pharma Group Inc.

Ascentage Pharma Group Inc. is a global biopharmaceutical company dedicated to developing innovative therapies for cancer and age-related diseases. With a strong focus on the discovery and development of novel small molecule drugs, the company leverages its proprietary technology platforms to address unmet medical needs in oncology and other therapeutic areas. Ascentage Pharma is committed to advancing its robust pipeline through rigorous clinical trials, emphasizing safety and efficacy, and aims to bring transformative treatments to patients worldwide. The company’s collaborative approach fosters partnerships with academic institutions and industry leaders, enhancing its capabilities in drug development and commercialization.

Locations

Houston, Texas, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0