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

InnoCare Pharma

Status and phase: Active, not recruiting; Phase 2

Conditions: PCNSL; Secondary Central Nervous System Lymphoma

Treatments: Drug: ICP-022

Study type: Interventional

Funder types: Industry

Identifiers

NCT04438044

ICP-CL-00106

Details and patient eligibility

About

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

Full 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 .

Enrollment: 61 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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61 participants in 1 patient group

ICP-022

Experimental group

Description:

150mg,QD

Treatment:

Drug: ICP-022