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

February 20, 2025 updated by: Beijing InnoCare Pharma Tech Co., Ltd.

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
68

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ICP-490
Drug: ICP-490
Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
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
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
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
Through study completion，an average of 3 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
PK parameters: maximum concentration (Cmax)
Time Frame: Through study completion，an average of 3 years
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
Through study completion，an average of 3 years
PK parameters: half-life (T1/2)
Time Frame: Through study completion，an average of 3 years
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
Through study completion，an average of 3 years
PK parameters: apparent clearance (CL/F)
Time Frame: Through study completion，an average of 3 years
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
Through study completion，an average of 3 years
PK parameters:Steady-state PK parameters
Time Frame: Through study completion，an average of 3 years
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
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
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
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
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
Through study completion，an average of 3 years
Overall survival (OS)
Time Frame: Through study completion，an average of 3 years
Through study completion，an average of 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Beijing InnoCare Pharma Tech Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 20, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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