Study on the Safety of New Dosing Schedules for Sonrotoclax in Treating Blood Cancers
Sponsor: BeiGene
ClinicalTrials ID:NCT06697184
This clinical trial is exploring the safety of new ways to gradually increase the dose of the experimental drug sonrotoclax in patients with blood cancers, focusing on avoiding side effects like tumor lysis syndrome.
Patient Parameters
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Program Overview
The study aims to test the safety of new dosing schedules for sonrotoclax, an experimental drug for blood cancers. Sonrotoclax works by blocking a protein that helps cancer cells survive, potentially slowing or stopping their growth. The study will gradually increase the dose of sonrotoclax to find the safest way to reach the target dose, while monitoring for side effects. The study will be conducted in two parts: first, testing the new dosing schedules in a small group, and then expanding to a larger group if the schedules are safe. The study will take place at multiple centers worldwide and will last about 17 months.
Description
This study is testing new ways to safely increase the dose of sonrotoclax, a drug that targets a protein called BCL-2, which helps blood cancer cells survive. By blocking BCL-2, sonrotoclax may help slow down or kill cancer cells. The study will focus on avoiding a side effect called tumor lysis syndrome, which can happen when cancer cells break down too quickly.
In the first part of the study, small groups of 5 to 6 participants will try different dosing schedules to see if they are safe. If a schedule is safe, it will be tested in a larger group of about 50 participants. The goal is to find a dosing schedule that is safe, simple, and effective.
Sonrotoclax is being tested alongside zanubrutinib, a drug that blocks another protein called BTK, which also helps cancer cells survive. Zanubrutinib is already approved in many countries for treating blood cancers like Chronic Lymphocytic Leukemia (CLL).
The study will take place at various locations around the world and will last approximately 17 months.
Eligibility Criteria
Inclusion Criteria
- Be in stable health with an ECOG performance status of 2 or less.
- Have good organ function and no recent blood transfusions or growth factor treatments.
- If able to have children, agree to use effective birth control and not donate eggs during the study and for a period after the last dose.
- Have a confirmed diagnosis of Chronic Lymphocytic Leukemia (CLL) that requires treatment.
- Have at least one measurable tumor on a CT or MRI scan and no history of certain other blood disorders.
Exclusion Criteria
- Unable to follow the study requirements.
- Have active hepatitis B or C infections.
- Have HIV unless specific conditions are met.
- Have had major surgery within 28 days before starting the study treatment.
- Have received prior treatment for CLL.
- Have uncontrolled autoimmune blood disorders that need treatment.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Moffitt Cancer Center | 33612-9497 | Tampa | Florida |
| Fort Wayne Medical Oncology and Hematology | 46804 | Fort Wayne | Indiana |
| The University of Kansas Cancer Center | 66205 | Westwood | Kansas |
| Dana Farber Cancer Institute | 02215 | Boston | Massachusetts |
| Washington University School of Medicine | 63110 | Saint Louis | Missouri |
| Fred Hutchinson Cancer Research Center | 98109 | Seattle | Washington |
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