A Study of ICP-022 in Patients With R/R DLBCL

NCT ID: NCT04438005

Last Updated: 2024-05-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-07
• Study Completion Date: 2021-12-13

Brief Summary

It is a phase II, multicenter, open-label study is to evaluate the safety, efficacy and pharmacokinetics of a novel BTK inhibitor, ICP-022, in approximately 85 subjects with R/R DLBCL. There will be no control group in this study. Each subject will receive treatment orally every day in 28-day cycles. Each cycle starts immediately after the previously completed cycle without a break between cycles.

Conditions

Diffuse Large B Cell Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ICP-022

Group Type: EXPERIMENTAL

ICP-022

Intervention Type: DRUG

ICP-022 is a white, round, uncoated tablet, 50 mg. It is administered orally at the dose of 150 mg/day from day 1 to day 28 of each cycle for up to a total of 6 cycles or until progression.

Interventions

ICP-022

ICP-022 is a white, round, uncoated tablet, 50 mg. It is administered orally at the dose of 150 mg/day from day 1 to day 28 of each cycle for up to a total of 6 cycles or until progression.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Men and women between 18 and 75 years old,

2. Histologically confirmed diffuse large B-cell lymphoma（DLBCL）with MyD88 L265P and CD79B positive, at least one measurable tumor of greater than 1.5 centimeter in long axis by contrast-enhanced CT/MRI,

3. ECOG performance status of 0-2,

4. Voluntary written informed consent prior to trail screening.

Exclusion Criteria

1. History of other active malignancies, unless cured without evidence of relapse or metastasis within 5 years of study entry

2. History of Richter's syndrome

3. Current or history of lymphoma involved central nervous system

4. Prior corticosteroids (at dosages equivalent to prednisone > 20 mg/day) given with anti-neoplastic intent within 7 days, prior chemotherapy, targeted therapy, radiation therapy, or antibody based therapies or anti-cancer TCM within 4 weeks of the start of study drug.

5. The investigator considers other conditions unsuitable for this study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing InnoCare Pharma Tech Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Peking University Third Hospital

Beijing, Beijing Municipality, China

Affiliated Tumor Hospital of Harbin Medical University

Haerbin, Heilongjiang, China

Jiangsu Province Hospital

Nanjing, Jiangsu, China

Shengjing Hospital of China Medical University

Shenyang, Liaoning, China

The Fourth Hospital of Hebei Medical University

Hebei, Shijiazhuang, China

Hematology Hospital of Chinese Academy of Medical Sciences (Institute of Hematology, Chinese Academy of Medical Sciences)

Tianjin, Tianjin Municipality, China

The First Affiliated Hospital of Zhejiang University Medical College

Hangzhou, Zhejiang, China

Countries

China

Other Identifiers

ICP-CL-00108

Identifier Type: -

Identifier Source: org_study_id