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

Phase 1

Not yet recruiting

• Conditions: Relapsed or Refractory Non-Hodgkin Lymphoma
• Interventions: Drug: ICP-490

• Registration Number: NCT06845241
• Lead Sponsor: Beijing InnoCare Pharma Tech Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study Start: 2025-02
• Study First Submitted: 2025-02-20
• Study First Submitted QC: 2025-02-20
• Last Update Submitted: 2025-02-20
• Study First Posted: 2025-02-25
• Last Update Posted: 2025-02-25
• Primary Completion: 2028-07
• Study Completion: 2028-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ICP-490	ICP-490	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Overall survival (OS)	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: maximum concentration (Cmax)	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
The overall response rate (ORR) 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
PK parameters: apparent clearance (CL/F)	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
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
Complete response rate (CRR) 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

Trial Locations

Locations (6)

Fujian Cancer Hospital; 🇨🇳 Fu zhou, Fujian, China

Sun Yat-sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China

Henan Cancer Hosptital; 🇨🇳 Zhengzhou, Henan, China

The First Affiliated Hospital of Nanchang University; 🇨🇳 Nan chang, Jiang xi, China

Tianjin Medical University Cancer Institute & Hospital; 🇨🇳 Tianjin, Tianjin, China

The Second Affiliated Hospital of Kunming Medical University; 🇨🇳 Kun ming, Yun Nan, China