Clinical trial NCT06845241: Evaluate the Safety, Tolerability, and Efficacy of ICP-490 in Patients with Relapsed or Refractory Non-Hodgkin Lymphoma
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Relapsed or Refractory Non-Hodgkin Lymphoma
Lead sponsor: Beijing InnoCare Pharma Tech Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-02-25
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Incidence, type, and severity of adverse events (AEs) as judged according to NCI-CTCAE V5.0
timeFrame: Through study completion，an average of 3 years
measure: Incidence, type, and severity of dose-limiting toxicities (DLTs);
timeFrame: Through study completion，an average of 3 years
measure: Recommended Phase 2 Doses（RP2Ds） and/or maximum tolerated doses（MTDs）.
timeFrame: Through study completion，an average of 3 years
measure: ORR assessed according to the Lugano criteria (Cheson 2014).
timeFrame: Through study completion，an average of 3 years
Secondary outcomes:
measure: PK parameters: maximum concentration (Cmax)
timeFrame: Through study completion，an average of 3 years
measure: PK parameters: time to maximum concentration (Tmax)
timeFrame: Through study completion，an average of 3 years
measure: PK parameters: half-life (T1/2)
timeFrame: Through study completion，an average of 3 years
measure: PK parameters: area under the concentration-time curve (AUC0-∞ and AUC0-t)
timeFrame: Through study completion，an average of 3 years
measure: PK parameters: apparent clearance (CL/F)
timeFrame: Through study completion，an average of 3 years
measure: PK parameters: apparent volume of distribution during terminal phase (Vz/F)
timeFrame: Through study completion，an average of 3 years
measure: PK parameters:Steady-state PK parameters
timeFrame: Through study completion，an average of 3 years
measure: The overall response rate (ORR) assessed according to the Lugano criteria (Cheson 2014).
timeFrame: Through study completion，an average of 3 years
measure: Complete response rate (CRR) assessed according to the Lugano criteria (Cheson 2014).
timeFrame: Through study completion，an average of 3 years
measure: Time to response (TTR) assessed according to the Lugano criteria (Cheson 2014).
timeFrame: Through study completion，an average of 3 years
measure: Duration of response (DOR) assessed according to the Lugano criteria (Cheson 2014).
timeFrame: Through study completion，an average of 3 years
measure: Progression-free survival (PFS) assessed according to the Lugano criteria (Cheson 2014).
timeFrame: Through study completion，an average of 3 years
measure: Overall survival (OS)
timeFrame: Through study completion，an average of 3 years
Other outcomes:
Locations:
city: Fu zhou
country: China
facility: Fujian Cancer Hospital
state: Fujian
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
city: Zhengzhou
country: China
facility: Henan Cancer Hosptital
state: Henan
city: Nan chang
country: China
facility: The First Affiliated Hospital of Nanchang University
state: Jiang xi
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute & Hospital
state: Tianjin
city: Kun ming
country: China
facility: The Second Affiliated Hospital of Kunming Medical University
state: Yun Nan
Study officials:
References: