Non Hodgkin Lymphoma (NHL)
Conditions
Keywords
Relapsed, Refractory, Lymphoma, NHL, FL, MCL, MZL
Brief summary
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
Detailed 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.
Interventions
DRUGNB02 (Poseltinib)
Dose Level 1, Dose Level 2, Dose Level 3
Sponsors
NOBO Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MTD(maximum tolerated dose) or OBD(optimal biological dose) | Approximately 48 Months | MTD(maximum tolerated dose) or OBD(optimal biological dose) |
| AEs | Approximately 48 Months | AEs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic (PK) Ctrough | Day 147 | Pharmacokinetic (PK) parameters from plasma samples |
| Pharmacokinetic (PK) t1/2 | Day 147 | Pharmacokinetic (PK) parameters from plasma samples |
| Pharmacokinetic (PK) CL/F | Day 147 | Pharmacokinetic (PK) parameters from plasma samples |
| Pharmacokinetic (PK) Vz/F | Day 147 | Pharmacokinetic (PK) parameters from plasma samples |
| Pharmacokinetic (PK) Cmax | Day 147 | Pharmacokinetic (PK) parameters from plasma samples |
| Pharmacokinetic (PK) AUCtau | Day 147 | Pharmacokinetic (PK) parameters from plasma samples |
| Pharmacokinetic (PK) Tmax | Day 147 | Pharmacokinetic (PK) parameters from plasma samples |
| Overall response rate (ORR) | Approximately 48 Months | To evaluate preliminary anti-tumor activity |
| Duration of response (DoR) | Approximately 48 Months | To evaluate preliminary anti-tumor activity |
| Time to response (TTR) | Approximately 48 Months | To evaluate preliminary anti-tumor activity |
| Progression-free survival (PFS) | Approximately 48 Months | To evaluate preliminary anti-tumor activity |
| Overall Survival (OS) | Approximately 48 Months | To evaluate preliminary anti-tumor activity |
Countries
South Korea
Outcome results
None listed