DZD8586 in Patients With Relapsed or Refractory CLL/SLL (TAI-SHAN8)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorDizal Pharmaceuticals
About this trial
This study will treat patients with CLL/SLL whose disease comes back or is not responding to prior therapy, or if they can not bear side effects of the prior treatment. This study will assess the anti-tumor activity of DZD8586 as monotherapy. It will help to understand what type of side effects may occur with the drug treatment. It will also measure the levels of drug in the body.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male and female ≥ 18 years of age.
ECOG performance status 0-2.
Confirmed diagnosis of CLL/SLL with indication for treatment.
Adequate bone marrow reserve and organ system functions.
Disqualifiers
CNS involvement or Richter transformation.
Stem cell transplantation, cell therapy, or gene therapy within 90 days. Approved small molecule therapy within 5 half-lives, monoclonal antibodies and antibody-drug conjugates within 28 days.
Major surgery or significant traumatic injury within 4 weeks. Live attenuated vaccines or viral vector vaccines within 4 weeks.
Take vitamin K antagonists or take more than 2 anticoagulants or antiplatelet drugs at the same time. Take proton pump inhibitors or strong CYP3A inhibitors or inducers.
Trial design
Design model
Sequential
Treatments tested in this trial
DZD8586
DrugDaily oral dose of DZD8586 at 25 mg.
DZD8586
DrugDaily oral dose of DZD8586 at 50 mg.
DZD8586
DrugDaily oral dose of DZD8586 at 75 mg.
Treatment groups
155 Participants
are divided into 3 treatment groupsGroup A: Daily dose of DZD8586 at 25 mgExperimental treatment 1 intervention
Group B: Daily dose of DZD8586 at 50 mgExperimental treatment 1 intervention
Group C: Daily dose of DZD8586 at 75 mgExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Objective Response Rate assessed by investigators
Time frame
assessed up to 2 yearsSecondary outcomes
1
Incidence of adverse event
Time frame
30 days after the last dose, assessed up to 2 yearsSponsors and contacts
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Source ClinicalTrials.gov