Overview
This trial is an open-label, multicenter, monotherapy, dose-escalation, phase 1 clinical trial to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary anti-tumor activity of NB02 (posseltinib) in patients with relapsed/refractory NHL including FL, MCL and MZL
Description
The study will conduct dose-finding. The dose-finding will be set as 3+3 design to seek candidates for optimal doses. Patients will receive study drugs to determine the MTD and/or OBD. In this study, OBD is defined as the most reasonable dose considering the benefit/risk ratio from available non-clinical and clinical data. The OBD will be determined based on available safety, PK/PD, and preliminary efficacy data, with a focus on identifying the dose that optimally balances clinical activity and tolerability.
Eligibility
Inclusion Criteria:
- Age 19 to 80 years.
- Patients must voluntarily agree to participate in the study and provide written informed consent prior to any study-related procedures.
- Patients with histologically confirmed follicular lymphoma, mantle cell lymphoma or marginal zone lymphoma.
- relapsed/refractory Patients who have received more than two prior lines of therapy.
- Measurable disease based on Lugano classification.
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
- Adequate organ function including:
Exclusion Criteria:
- Previous treatment with NB02 (poseltinib).
- Patients who have experienced progression on BTKi mono or BTKi containing regimen (However, patients who discontinued treatment due to adverse-effect-related intolerance or for economic or social reasons remain eligible for enrollment).
- Unable to take oral medication.
- Inability to comply with study and follow-up procedures.
- Concurrent use of other investigational drugs or enrollment in another clinical trial within 4 weeks prior to study drug administration.
- Patients who have previously been treated with NB02 (poseltinib) or any other BTK inhibitors (e.g., ibrutinib, acalabrutinib, zanubrutinib).
- Known HIV, HCV and HBV infection with active diseases