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

NCT06845241 | Not Yet Recruiting Phase 1

• 1 other identifier: ICP-CL-01102
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 6

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.

Conditions

Relapsed or Refractory Non-Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (13)

• PK parameters: maximum concentration (Cmax)

  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

• PK parameters: apparent clearance (CL/F)

  Through study completion，an average of 3 years

Study Arms (1)

ICP-490

EXPERIMENTAL

Drug: ICP-490

Interventions

ICP-490 DRUG

Specified dose on specified days

ICP-490

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing InnoCare Pharma Tech Co., Ltd.: lead

Study Sites (6)

Fujian Cancer Hospital

Fuzhou, Fujian, 350014, China

Location

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510000, China

Location

Henan Cancer Hosptital

Zhengzhou, Henan, 450000, China

Location

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330000, China

Location

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, 300000, China

Location

The Second Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, 650000, China

Location

MeSH Terms

Conditions

Recurrence; Lymphoma, Non-Hodgkin

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Alexia Lu

CONTACT

010-66609745; CO_HGRAC@innocarepharma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2025
• First Posted: February 25, 2025
• Study Start: February 1, 2025
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: February 25, 2025

Record last verified: 2025-02

Locations

CN (6)