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

NCT ID: NCT06845241

Last Updated: 2025-02-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-28

Study Completion Date

2028-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Relapsed or Refractory Non-Hodgkin Lymphoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ICP-490

Group Type EXPERIMENTAL

ICP-490

Intervention Type DRUG

Specified dose on specified days

Interventions

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ICP-490

Specified dose on specified days

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing InnoCare Pharma Tech Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Fujian Cancer Hospital

Fuzhou, Fujian, China

Site Status

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Site Status

Henan Cancer Hosptital

Zhengzhou, Henan, China

Site Status

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Site Status

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, China

Site Status

The Second Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, China

Site Status

Countries

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China

Central Contacts

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Alexia Lu

Role: CONTACT

010-66609745

Facility Contacts

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Hui Wu

Role: primary

Zhiming Li

Role: primary

Keshu Zhou

Role: primary

Fei Li

Role: primary

Huilai Zhang

Role: primary

Zeping Zhou

Role: primary

Other Identifiers

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ICP-CL-01102

Identifier Type: -

Identifier Source: org_study_id

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