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Last Updated: August 14, 2024

CLINICAL TRIALS PROFILE FOR ICP-022

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Clinical Trials for ICP-022

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Trial ID	Title	Status	Sponsor	Phase	Summary
NCT03189017 ↗	A Phase I Study of ICP-022 in Healthy Subjects	Completed	Innocare Pharma Australia Pty Ltd	Phase 1	This is a single center, randomized, double-blind, placebo-controlled, dose escalation study in healthy subjects to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of ICP-022 following oral single and multiple escalating dose administration.
NCT03493217 ↗	A Study to Evaluate ICP-022 in Patients With CLL/ SLL	Active, not recruiting	Beijing InnoCare Pharma Tech Co., Ltd.	Phase 1/Phase 2	The phase I/II clinical study is to investigate the safety, tolerability and efficacy of ICP-022 in R/R CLL/SLL patients.
NCT03494179 ↗	A Study to Evaluate ICP-022 in Patients With R/R Mantle Cell Lymphoma (MCL)	Active, not recruiting	Beijing InnoCare Pharma Tech Co., Ltd.	Phase 1/Phase 2	The phase I/II clinical study is to investigate the safety, tolerability and pharmacokinetics/ pharmacodynamics of ICP-022.
NCT03797456 ↗	A Study to Evaluate ICP-022 in Patients With R/R Marginal Zone Lymphoma (MZL)	Recruiting	Beijing InnoCare Pharma Tech Co., Ltd.	Phase 2	The phase II clinical study is to investigate the safety, tolerability, efficacy and pharmacokinetics of ICP-022. Safety, tolerability evaluation, and anti-tumor effects of ICP-022 in Chinese patients with R/R MZL will be evaluated in approximately 80 subjects. Pharmacokinetics of ICP-022 will be evaluated in approximately 20 subjects.
NCT04014205 ↗	A Study of Tyrosine Kinase Inhibitor Orelabrutinib (ICP-022) in Patients With r/r B-Cell Malignancies	Recruiting	Beijing InnoCare Pharma Tech Co., Ltd.	Phase 1/Phase 2	This is a Phase I/II, multicenter, open-label study to evaluate the safety, efficacy, tolerability, and pharmacokinetics of a novel BTK inhibitor, Orelabrutinib (ICP-022) in Patients with B-cell malignancies. The study contains two parts, Part 1 (dose escalation) and Part 2 (dose expansion).
NCT04304040 ↗	A Study of MIL62 Combined With Orelabrutinib for the Treatment of R/R CD20+B Cell Lymphoma	Recruiting	Beijing InnoCare Pharma Tech Co., Ltd.	Phase 1/Phase 2	Dose escalation and expansion phase I/IIa clinical study of recombinant humanized type II CD20 monoclonal antibody MIL62 injection combined with a novel selective Bruton Tyrosine Kinase(BTK) inhibitor Orelabrutinib in the treatment of recurrent/refractory CD20+B cell lymphoma
>Trial ID	>Title	>Status	>Sponsor	>Phase	>Summary

Clinical Trial Conditions for ICP-022

Condition Name

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Condition Name
Intervention	Trials
Chronic Lymphocytic Leukemia	2
Small Lymphocytic Lymphoma	2
Systemic Lupus Erythematosus	2
Mantle Cell Lymphoma	2
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Condition MeSH

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Condition MeSH
Intervention	Trials
Lymphoma	9
Leukemia, Lymphoid	3
Leukemia, Lymphocytic, Chronic, B-Cell	3
Lymphoma, B-Cell	3
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Clinical Trial Locations for ICP-022

Trials by Country

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Trials by Country
Location	Trials
China	97
United States	14
Australia	1
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Trials by US State

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Trials by US State
Location	Trials
Kansas	1
Illinois	1
Florida	1
California	1
Washington	1
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Clinical Trial Progress for ICP-022

Clinical Trial Phase

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Clinical Trial Phase
Clinical Trial Phase	Trials
Phase 3	2
Phase 2	7
Phase 1/Phase 2	5
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Clinical Trial Status

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Clinical Trial Status
Clinical Trial Phase	Trials
Recruiting	8
Not yet recruiting	4
Completed	2
[disabled in preview]	2
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Clinical Trial Sponsors for ICP-022

Sponsor Name

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Sponsor Name
Sponsor	Trials
Beijing InnoCare Pharma Tech Co., Ltd.	12
Innocare Pharma Australia Pty Ltd	1
Shandong University	1
[disabled in preview]	2
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Sponsor Type

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Sponsor Type
Sponsor	Trials
Industry	13
Other	3
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