Evaluate the Safety, Tolerability, and Efficacy of ICP-490 in Patients with Relapsed or Refractory Non-Hodgkin Lymphoma

Official title

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

Overview

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

• Drug ICP-490
  Specified dose on specified days

Primary outcome measures

• Incidence, type, and severity of adverse events (AEs) as judged according to NCI-CTCAE V5.0 [Time frame: Through study completion，an average of 3 years]
• Incidence, type, and severity of dose-limiting toxicities (DLTs); [Time frame: Through study completion，an average of 3 years]
• Recommended Phase 2 Doses（RP2Ds） and/or maximum tolerated doses（MTDs）. [Time frame: Through study completion，an average of 3 years]
• ORR assessed according to the Lugano criteria (Cheson 2014). [Time frame: Through study completion，an average of 3 years]

Secondary outcome measures (12)

• PK parameters: maximum concentration (Cmax) [Time frame: Through study completion，an average of 3 years]
• PK parameters: time to maximum concentration (Tmax) [Time frame: Through study completion，an average of 3 years]
• PK parameters: half-life (T1/2) [Time frame: Through study completion，an average of 3 years]
• PK parameters: area under the concentration-time curve (AUC0-∞ and AUC0-t) [Time frame: Through study completion，an average of 3 years]
• PK parameters: apparent clearance (CL/F) [Time frame: Through study completion，an average of 3 years]
• PK parameters: apparent volume of distribution during terminal phase (Vz/F) [Time frame: Through study completion，an average of 3 years]
• PK parameters:Steady-state PK parameters [Time frame: Through study completion，an average of 3 years]
• The overall response rate (ORR) assessed according to the Lugano criteria (Cheson 2014). [Time frame: Through study completion，an average of 3 years]
• Complete response rate (CRR) assessed according to the Lugano criteria (Cheson 2014). [Time frame: Through study completion，an average of 3 years]
• Time to response (TTR) assessed according to the Lugano criteria (Cheson 2014). [Time frame: Through study completion，an average of 3 years]
• Duration of response (DOR) assessed according to the Lugano criteria (Cheson 2014). [Time frame: Through study completion，an average of 3 years]
• Progression-free survival (PFS) assessed according to the Lugano criteria (Cheson 2014). [Time frame: Through study completion，an average of 3 years]

Eligibility criteria

Inclusion criteria

• Aged ≥ 18 years old.
• Diagnosed as relapsed or refractory non-hodgkin lymphoma .
• The patient must have measurable diseases.
• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-2.
• Patients must have adequate organ function.
• Expected survival time ≥ 3 months.
• All toxicities caused by prior anticancer therapy must have recovered to Grade ≤ 1 (based on CTCAE v5.0) except alopecia and fatigue.
• Female patients of childbearing potential should have a negative blood pregnancy test result within 48 h prior to the first dose of investigational drug.
• 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

• Known active central nervous system (CNS) involvement Lymphoma.
• Excludes other active malignancies within 3 years before first dose, except locally curable cancers after radical treatment.
• Uncontrolled or severe cardiovascular disorders.
• Presence or history of clinically significant CNS diseases.
• Any active infection requiring intravenous infusion for systemic treatment within 14 days prior to the first dose of the study drug.
• Presence or history existence of diseases restricted by the protocol.
• Major surgery within 28 days before first dose.
• 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.
• 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.
• Patients with a history of intolerance to thalidomide, lenalidomide, or any component contained in the formulation of the investigational drug.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

China · 6 centers

• Fujian Cancer Hospital — Fuzhou
• Sun Yat-sen University Cancer Center — Guangzhou
• Henan Cancer Hosptital — Zhengzhou
• The First Affiliated Hospital of Nanchang University — Nanchang
• Tianjin Medical University Cancer Institute & Hospital — Tianjin
• The Second Affiliated Hospital of Kunming Medical University — Kunming

Identifiers

NCT: NCT06845241 · ICP-CL-01102

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗