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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Relapsed or Refractory Non-Hodgkin Lymphoma
• Intervention / Treatment: Drug: ICP-490

• Study Type: Interventional
• Enrollment (Estimated): 68
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Alexia Lu; Phone Number: 010-66609745; Email: CO_HGRAC@innocarepharma.com

Study Locations

• China
  • Fujian
    • Fu zhou, Fujian, China, 350014
      • Fujian Cancer Hospital
      • Contact: Hui Wu
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Sun yat-sen University Cancer Center
      • Contact: Zhiming Li
  • Henan
    • Zhengzhou, Henan, China, 450000
      • Henan Cancer Hosptital
      • Contact: Keshu Zhou
  • Jiang xi
    • Nan chang, Jiang xi, China, 330000
      • The First Affiliated Hospital of Nanchang University
      • Contact: Fei Li
  • Tianjin
    • Tianjin, Tianjin, China, 300000
      • Tianjin Medical University Cancer Institute & Hospital
      • Contact: Huilai Zhang
  • Yun Nan
    • Kun ming, Yun Nan, China, 650000
      • The Second Affiliated Hospital of Kunming Medical University
      • Contact: Zeping Zhou

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ICP-490	Drug: ICP-490; Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Time Frame
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
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
Complete response rate (CRR) assessed according to the Lugano criteria (Cheson 2014).	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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2025
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: February 20, 2025
• First Submitted That Met QC Criteria: February 20, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 20, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma; Lymphoma, Non-Hodgkin
• Other Study ID Numbers: ICP-CL-01102

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No