A Study to Evaluate ICP-022 in Patients With R/R PCNSL and SCNSL

Phase 2

Active, not recruiting

• Conditions: PCNSL; Secondary Central Nervous System Lymphoma
• Interventions: Drug: ICP-022

• Registration Number: NCT04438044
• Lead Sponsor: Beijing InnoCare Pharma Tech Co., Ltd.

Brief Summary

The phase II clinical study is to investigate the safety, tolerability, efficacy and pharmacokinetics of ICP-022.

Detailed Description

Safety, tolerability evaluation, and anti-tumor effects of ICP-022 in Chinese patients with Recurrent/Refractory Central Nervous System Lymphoma (PCNSL) and Recurrent/Refractory Secondary Central Nervous System Lymphoma (SCNSL) will be evaluated in approximately 82 subjects. Pharmacokinetics of ICP-022 will be evaluated in approximately 20 subjects .

Study Timeline

• Study Start: 2019-06-18
• Study First Submitted: 2020-06-16
• Study First Submitted QC: 2020-06-17
• Study First Posted: 2020-06-18
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-10
• Last Update Posted: 2022-10-12
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 61

Inclusion Criteria

1. Men and women ≥ 18, and ≤75 years of age
2. Histologically documented PCNSL, or histologically documented systemic diffuse large B-cell lymphoma (DLBCL) for SCNSL.
3. Subjects with refractory or relapsed disease, one prior CNS directed therapy, and ≤ 4 systemic treatments.
4. ECOG performance status of 0-2
5. Able to provide signed written informed consent

Key

Exclusion Criteria

1. Patients with SCNSL actively receiving treatment for extra-CNS disease are excluded
2. T-cell lymphoma.
3. Patient requires more than 8 mg of dexamethasone daily or the equivalent.
4. Non-hematological toxicity must recover to ≤ Grade 1 from prior anti-cancer therapy (except for alopecia)
5. Known active infection with HBV, HCV or HIV.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ICP-022	ICP-022	150mg,QD

Primary Outcome Measures

Name	Time	Method
The efficacy measured by overall response rate (ORR)	Cycle 1-6 once every 2 cycles; more than 6 cycles once every 3 cycles. Each cycle is 28 days

Secondary Outcome Measures

Name	Time	Method
The efficacy measured by duration of response (DOR)	cycle 1-6 once every 2 cycles; monre than 6 cycles once every 3 cycles. Each cycle is 28 days
The efficacy measured by progression free survival (PFS)	cycle 1-6 once every 2 cycles; more than 6 cycles once every 3 cycles. Each cycle is 28 days
The occurrence of adverse events and serious adverse events	every cycle, first cycle every week. Each cycle is 28 days	The safety of ICP-022 measured by the occurrence of adverse events and serious adverse events according to NCI-CTCAE 4.03 grading criteria

Trial Locations

Locations (5)

Capital Medical University Xuanwu Hospital; 🇨🇳 Beijing, Beijing, China

Beijing Cancer Hospital; 🇨🇳 Beijing, Beijing, China

Beijing Tiantan Hospital affiliated to Capital Medical University; 🇨🇳 Beijing, Beijing, China

Guangdong General Hospital; 🇨🇳 Guangzhou, Guangdong, China

Huashan Hospital affiliated to Fudan University; 🇨🇳 Shanghai, Shanghai, China