NB02(POSELTINIB) Monotherapy in R/R Non-Hodgkin's Lymphoma (POTENTIAL-M)

NOBO Medicine

Status and phase: Enrolling; Phase 1

Conditions: Non Hodgkin Lymphoma (NHL)

Treatments: Drug: NB02 (Poseltinib)

Study type: Interventional

Funder types: Industry

Identifiers

NCT07114367

NB02-L02

Details and patient eligibility

About

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

Full 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.

Enrollment: 9 estimated patients

Sex: All

Ages: 19 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age 19 to 80 years.
2. Patients must voluntarily agree to participate in the study and provide written informed consent prior to any study-related procedures.
3. Patients with histologically confirmed follicular lymphoma, mantle cell lymphoma or marginal zone lymphoma.
4. relapsed/refractory Patients who have received more than two prior lines of therapy.
5. Measurable disease based on Lugano classification.
6. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
7. Adequate organ function including:

Exclusion criteria

1. Previous treatment with NB02 (poseltinib).
2. 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).
3. Unable to take oral medication.
4. Inability to comply with study and follow-up procedures.
5. Concurrent use of other investigational drugs or enrollment in another clinical trial within 4 weeks prior to study drug administration.
6. Patients who have previously been treated with NB02 (poseltinib) or any other BTK inhibitors (e.g., ibrutinib, acalabrutinib, zanubrutinib).
7. Known HIV, HCV and HBV infection with active diseases

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 1 patient group

NB02 (Poseltinib)

Experimental group

Description:

Dose Level 1 Dose Level 2 Dose Level 3

Treatment:

Drug: NB02 (Poseltinib)