Orelabrutinib

Generic Name: Orelabrutinib

Drug Type: Small Molecule

Chemical Formula: C_₂₆H_₂₅N_₃O_₃

CAS Number: 1655504-04-3

Unique Ingredient Identifier: WJA5UO9E10

Background: Orelabrutinib is under investigation in clinical trial NCT04305197 (A Study of ICP-022 in Patients With Systemic Lupus Erythematosus (SLE)).

Indication: ⑴既往至少接受过一种治疗的成人套细胞淋巴瘤（MCL）患者。

⑵既往至少接受过一种治疗的成人慢性淋巴细胞白血病（CLL）/小淋巴细胞淋巴瘤（SLL）患者。

Clinical Trials

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

First Posted Date: 2020-06-18

Last Posted Date: 2022-10-12

Lead Sponsor: Beijing InnoCare Pharma Tech Co., Ltd.

Target Recruit Count: 61

Registration Number: NCT04438044

Locations: 🇨🇳
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

and more 2 locations

A Study of ICP-022 in Patients With Systemic Lupus Erythematosus (SLE)

Phase 1

Completed

Conditions: Systemic Lupus Erythematosus

Interventions: Drug: ICP-022
Drug: Placebos

First Posted Date: 2020-03-12

Last Posted Date: 2022-11-30

Lead Sponsor: Beijing InnoCare Pharma Tech Co., Ltd.

Target Recruit Count: 60

Registration Number: NCT04305197

Locations: 🇨🇳
The First Affiliated Hospital of Bengbu Medical College, Bengbu, Anhui, China
🇨🇳
Peking University People's Hospital, Beijing, Beijing, China
🇨🇳
Peking University third hospital, Beijing, Beijing, China

and more 8 locations

A Study of MIL62 Combined With Orelabrutinib for the Treatment of R/R CD20+B Cell Lymphoma

Phase 1

Active, not recruiting

Conditions: B-cell Lymphoma Recurrent
B-cell Lymphoma Refractory

Interventions: Drug: Orelabrutinib
Drug: Recombinant humanized monoclonal antibody MIL62 injection

First Posted Date: 2020-03-11

Last Posted Date: 2024-02-07

Lead Sponsor: Beijing InnoCare Pharma Tech Co., Ltd.

Target Recruit Count: 43

Registration Number: NCT04304040

Locations: 🇨🇳
The First Affiliated Hospital of Bengbu Medical College, Bengbu, Anhui, China
🇨🇳
Beijing Hospital, Beijing, Beijing, China
🇨🇳
Affiliated Hospital of Hebei University, Baoding, Hebei, China

and more 7 locations

A Study of Tyrosine Kinase Inhibitor Orelabrutinib (ICP-022) in Patients With r/r B-Cell Malignancies

Phase 1

Active, not recruiting

Conditions: Part 2：B-cell Malignancies
Part 1：r/r B-cell Malignancies

Interventions: Drug: Orelabrutinib (ICP-022)

First Posted Date: 2019-07-10

Last Posted Date: 2023-04-18

Lead Sponsor: Beijing InnoCare Pharma Tech Co., Ltd.

Target Recruit Count: 81

Registration Number: NCT04014205

Locations: 🇺🇸
Los Angeles Cancer Network - Good Samaritan Hospital Location, Los Angeles, California, United States
🇺🇸
Desert Hematology Oncology Medical Group, Inc., Rancho Mirage, California, United States
🇺🇸
University of Pittsburgh - Hillman Cancer Center, Pittsburgh, Pennsylvania, United States

and more 33 locations

A Study to Evaluate ICP-022 in Patients With R/R Marginal Zone Lymphoma (MZL)

Phase 2

Completed

Conditions: MZL

Interventions: Drug: ICP-022

First Posted Date: 2019-01-09

Last Posted Date: 2024-04-18

Lead Sponsor: Beijing InnoCare Pharma Tech Co., Ltd.

Target Recruit Count: 111

Registration Number: NCT03797456

Locations: 🇨🇳
Henan Provincial People's Hospital, Zhengzhou, Henan, China
🇨🇳
The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China
🇨🇳
The Fourth Hospital of Hebei Medical University, Shijiazhuang, Hebei, China

and more 29 locations

A Study to Evaluate ICP-022 in Patients With R/R Mantle Cell Lymphoma (MCL)

Phase 1

Active, not recruiting

Conditions: Mantle Cell Lymphoma

Interventions: Drug: ICP-022

First Posted Date: 2018-04-11

Last Posted Date: 2023-06-05

Lead Sponsor: Beijing InnoCare Pharma Tech Co., Ltd.

Target Recruit Count: 120

Registration Number: NCT03494179

Locations: 🇨🇳
Fujian Medical University Union Hospital, Fuzhou, Fujian, China
🇨🇳
Peking Union Medical College Hospital, Beijing, Beijing, China
🇨🇳
Beijing Cancer Hospital, Beijing, Beijing, China

and more 28 locations

A Study to Evaluate ICP-022 in Patients With CLL/ SLL

Phase 1

Conditions: CLL/SLL

Interventions: Drug: ICP-022

First Posted Date: 2018-04-10

Last Posted Date: 2022-07-06

Lead Sponsor: Beijing InnoCare Pharma Tech Co., Ltd.

Target Recruit Count: 100

Registration Number: NCT03493217

Locations: 🇨🇳
Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China
🇨🇳
Tongji Hospital, Wuhan, Hubei, China
🇨🇳
Jiangsu Province Hospital, Nanjing, Jiangsu, China

and more 22 locations

A Phase I Study of ICP-022 in Healthy Subjects

Phase 1

Completed

Conditions: Systemic Lupus Erythematosus
Rheumatoid Arthritis

Interventions: Drug: Placebos
Drug: ICP-022

First Posted Date: 2017-06-16

Last Posted Date: 2019-08-01

Lead Sponsor: Innocare Pharma Australia Pty Ltd

Target Recruit Count: 64

Registration Number: NCT03189017

Locations: 🇦🇺
CMAX Clinical Research, Adelaide, South Australia, Australia

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