Relapsed or Refractory Non-Hodgkin Lymphoma
Conditions
Brief summary
This is a multi-center, non-randomized and open-label phase I/IIa clinical study to evaluate the safety, tolerability, and efficacy of ICP-490 in patients with relapsed or refractory non-hodgkin lymphoma.
Interventions
DRUGICP-490
Specified dose on specified days
Sponsors
Beijing InnoCare Pharma Tech Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Aged ≥ 18 years old. 2. Diagnosed as relapsed or refractory non-hodgkin lymphoma . 3. The patient must have measurable diseases. 4. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-2. 5. Patients must have adequate organ function. 6. Expected survival time ≥ 3 months. 7. All toxicities caused by prior anticancer therapy must have recovered to Grade ≤ 1 (based on CTCAE v5.0) except alopecia and fatigue. 8. Female patients of childbearing potential should have a negative blood pregnancy test result within 48 h prior to the first dose of investigational drug. 9. Male or Female of reproductive age must use contraception from 28 days before the first dose until at least 6 months after the last dose of the study drug.
Exclusion criteria
1. Known active central nervous system (CNS) involvement Lymphoma. 2. Excludes other active malignancies within 3 years before first dose, except locally curable cancers after radical treatment. 3. Uncontrolled or severe cardiovascular disorders. 4. Presence or history of clinically significant CNS diseases. 5. Any active infection requiring intravenous infusion for systemic treatment within 14 days prior to the first dose of the study drug. 6. Presence or history existence of diseases restricted by the protocol. 7. Major surgery within 28 days before first dose. 8. Any serious or uncontrolled systemic disease that the investigator believes may increase the risk associated with participating in the study or the administration of the study drug, or may affect the patient's ability to receive the study drug. 9. Patients who have received medications or foods with strong inhibitory or inductive effects on cytochrome P450 CYP3A, and proton pump inhibitors within 2 weeks prior to the first dose of investigational drug, or who are planning to receive proton pump inhibitors during the study. 10. Patients with a history of intolerance to thalidomide, lenalidomide, or any component contained in the formulation of the investigational drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence, type, and severity of adverse events (AEs) as judged according to NCI-CTCAE V5.0 | Through study completion，an average of 3 years |
| Incidence, type, and severity of dose-limiting toxicities (DLTs); | Through study completion，an average of 3 years |
| Recommended Phase 2 Doses（RP2Ds） and/or maximum tolerated doses（MTDs）. | Through study completion，an average of 3 years |
| ORR assessed according to the Lugano criteria (Cheson 2014). | Through study completion，an average of 3 years |
Secondary
| Measure | Time frame |
|---|---|
| PK parameters: apparent clearance (CL/F) | Through study completion，an average of 3 years |
| PK parameters: apparent volume of distribution during terminal phase (Vz/F) | Through study completion，an average of 3 years |
| PK parameters:Steady-state PK parameters | Through study completion，an average of 3 years |
| The overall response rate (ORR) assessed according to the Lugano criteria (Cheson 2014). | Through study completion，an average of 3 years |
| PK parameters: maximum concentration (Cmax) | Through study completion，an average of 3 years |
| Time to response (TTR) assessed according to the Lugano criteria (Cheson 2014). | Through study completion，an average of 3 years |
| Duration of response (DOR) assessed according to the Lugano criteria (Cheson 2014). | Through study completion，an average of 3 years |
| Progression-free survival (PFS) assessed according to the Lugano criteria (Cheson 2014). | Through study completion，an average of 3 years |
| Overall survival (OS) | Through study completion，an average of 3 years |
| Complete response rate (CRR) assessed according to the Lugano criteria (Cheson 2014). | Through study completion，an average of 3 years |
| PK parameters: time to maximum concentration (Tmax) | Through study completion，an average of 3 years |
| PK parameters: half-life (T1/2) | Through study completion，an average of 3 years |
| PK parameters: area under the concentration-time curve (AUC0-∞ and AUC0-t) | Through study completion，an average of 3 years |
Countries
China
Contacts
Primary ContactAlexia Lu
Outcome results
None listed