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

InnoCare Pharma

Status and phase: Not yet enrolling; Phase 2; Phase 1

Conditions: Relapsed or Refractory Non-Hodgkin Lymphoma

Treatments: Drug: ICP-490

Study type: Interventional

Funder types: Industry

Identifiers

NCT06845241

ICP-CL-01102

Details and patient eligibility

About

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.

Enrollment: 68 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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68 participants in 1 patient group

ICP-490

Experimental group

Treatment:

Drug: ICP-490