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Relapsed or Refractory Non-Hodgkin LymphomaPhase 1/2NCT06845241

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

A Phase 1/2 study testing ICP-490 in people with Relapsed or Refractory Non-Hodgkin Lymphoma, run by Beijing InnoCare Pharma Tech Co., Ltd. at 6 sites in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
ICP-490
Could I receive a placebo?
No, everyone receives an active treatment
How many people
68 participants
Where
6 sitesChina
Study dates
Feb 2025to Dec 2028
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

6 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Alexia Lu contact

010-66609745

CO_HGRAC@innocarepharma.com

6 sites in 1 country

China6 sites

  • Fujian Cancer Hospital

    Fuzhou, Fujian, 350014

    Hui Wu

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510000

    Zhiming Li

  • The Second Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan, 650000

    Zeping Zhou

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330000

    Fei Li

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, Tianjin Municipality, 300000

    Huilai Zhang

  • Henan Cancer Hosptital

    Zhengzhou, Henan, 450000

    Keshu Zhou

Other trials in China

About this study

Official title: 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.

Being tested
ICP-490
Medical subject headings
Recurrence, Lymphoma, Non-Hodgkin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ICP-490Drug

    Specified dose on specified days

Study groups in NCT06845241
Study groupRoleWhat they receive
ICP-490ExperimentalNot described
Receives: Drug: ICP-490

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence, type, and severity of adverse events (AEs) as judged according to NCI-CTCAE V5.0

    Measured: Through study completion，an average of 3 years

  2. Incidence, type, and severity of dose-limiting toxicities (DLTs);

    Measured: Through study completion，an average of 3 years

  3. Recommended Phase 2 Doses（RP2Ds） and/or maximum tolerated doses（MTDs）.

    Measured: Through study completion，an average of 3 years

  4. ORR assessed according to the Lugano criteria (Cheson 2014).

    Measured: Through study completion，an average of 3 years

Secondary outcomes (13)

  1. PK parameters: maximum concentration (Cmax)

    Measured: Through study completion，an average of 3 years

  2. PK parameters: time to maximum concentration (Tmax)

    Measured: Through study completion，an average of 3 years

  3. PK parameters: half-life (T1/2)

    Measured: Through study completion，an average of 3 years

  4. PK parameters: area under the concentration-time curve (AUC0-∞ and AUC0-t)

    Measured: Through study completion，an average of 3 years

  5. PK parameters: apparent clearance (CL/F)

    Measured: Through study completion，an average of 3 years

  6. PK parameters: apparent volume of distribution during terminal phase (Vz/F)

    Measured: Through study completion，an average of 3 years

  7. PK parameters:Steady-state PK parameters

    Measured: Through study completion，an average of 3 years

  8. The overall response rate (ORR) assessed according to the Lugano criteria (Cheson 2014).

    Measured: Through study completion，an average of 3 years

  9. Complete response rate (CRR) assessed according to the Lugano criteria (Cheson 2014).

    Measured: Through study completion，an average of 3 years

  10. Time to response (TTR) assessed according to the Lugano criteria (Cheson 2014).

    Measured: Through study completion，an average of 3 years

  11. Duration of response (DOR) assessed according to the Lugano criteria (Cheson 2014).

    Measured: Through study completion，an average of 3 years

  12. Progression-free survival (PFS) assessed according to the Lugano criteria (Cheson 2014).

    Measured: Through study completion，an average of 3 years

  13. Overall survival (OS)

    Measured: Through study completion，an average of 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Feb 2025
  2. Study startFeb 2025 (estimated)
  3. Primary completionJul 2028 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
68 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06845241
Sponsor's protocol ID
ICP-CL-01102
Status last verified
Feb 2025
First submitted
20 Feb 2025
Last updated
25 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing ICP-490 in people with Relapsed or Refractory Non-Hodgkin Lymphoma, run by Beijing InnoCare Pharma Tech Co., Ltd. at 6 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Alexia Lu (010-66609745, CO_HGRAC@innocarepharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06845241.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2025.

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