HQP1351 for Leukemia
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called HQP1351, a potential drug for certain types of leukemia. It aims to determine the best dose and understand the drug's movement through the body. The trial targets individuals with chronic myeloid leukemia (CML) or acute lymphoblastic leukemia (ALL) who have tried at least two other treatments without success. Those who have experienced resistance or side effects from previous treatments and continue to struggle with their condition may be suitable candidates. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.
Do I have to stop taking my current medications for the trial?
The trial requires that you stop taking any tyrosine kinase inhibitors (TKIs) at least 7 days before starting the study drug, HQP1351. If you are taking other medications that might interact with HQP1351, you may also need to stop those, but the protocol does not specify all such medications.
Is there any evidence suggesting that HQP1351 is likely to be safe for humans?
Research shows that HQP1351, also known as Olverembatinib, is generally well-tolerated by patients. Studies have found it can help people with certain types of leukemia who haven't responded well to other treatments. Reports from earlier trials indicate that patients experienced few serious side effects. For instance, one study found that HQP1351 was safe for people with chronic myeloid leukemia that didn't respond to other treatments. Another study confirmed its safety when used with another drug for a specific type of acute lymphoblastic leukemia.
In summary, current evidence suggests that HQP1351 is safe for people, with manageable side effects. However, as this trial is still in the early stages, more research is needed to fully understand its safety.12345Why do researchers think this study treatment might be promising for leukemia?
Unlike the standard leukemia treatments, which often involve chemotherapy or targeted therapies like tyrosine kinase inhibitors (TKIs), HQP1351 is a new type of TKI that targets specific mutations in cancer cells more precisely. Researchers are excited about HQP1351 because it can overcome resistance to current TKIs, a major hurdle in treating leukemia effectively. This precision could lead to better outcomes for patients who haven't had success with existing options. Plus, its potential for fewer side effects makes it a promising alternative for long-term treatment.
What evidence suggests that HQP1351 might be an effective treatment for leukemia?
Research has shown that HQP1351, also known as olverembatinib, may help treat certain types of leukemia. In studies with patients who have chronic myeloid leukemia and a specific mutation called T315I, HQP1351 worked well and was generally safe. One study found that after 36 months, 57.1% of patients did not experience disease progression, and 69.6% were still alive. These results suggest that HQP1351 could be a good option for patients who have not had success with other treatments. Participants in this trial will join various treatment cohorts to further evaluate the effectiveness and safety of HQP1351.26789
Who Is on the Research Team?
Yifan Zhai, MD, PhD
Principal Investigator
Ascentage Pharma Group Inc.
Are You a Good Fit for This Trial?
This trial is for people with chronic myelogenous leukemia (CML) or Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL), who have not responded well to at least two tyrosine kinase inhibitors (TKIs). Participants must be able to follow the study procedures and agree to use effective contraception. Those with certain health conditions, recent surgeries, active infections like HIV or hepatitis, poorly controlled diabetes, or a history of other cancers within the last year are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive HQP1351 orally every other day in 28-day cycles, with dose-limiting toxicity observation during the first cycle
Dose Escalation and Expansion
Cohort D involves dose escalation and expansion with HQP1351 and blinatumomab in 42-day cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- HQP1351
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ascentage Pharma Group Inc.
Lead Sponsor