A Study to Evaluate the Safety and Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of TJ011133 as Monotherapy and in Combination With Azacitidine (AZA) in Patients With Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

105

Participants

Timeline

Start Date

March 25, 2020

Primary Completion Date

December 15, 2023

Study Completion Date

December 15, 2023

Conditions
Acute Myeloid Leukemia (AML)Myelodysplastic Syndromes(MDS)
Interventions
DRUG

TJ011133

This is an open-label Phase 1/2a clinical study. The study will be conducted in two parts: Part I: Phase 1 dose escalation, TJ011133 is tentatively scheduled to be administered once weekly in 28-day treatment cycles;Part II: Phase 2a study TJ011133 will be administered at a dose of 30 mg/kg once weekly, and AZA will be administered at a dose of 75 mg/m2 by subcutaneous injection for 7 consecutive days from D1 to D7 in 28-day treatment cycles.

Trial Locations (26)

100032

Peking Union Medical College Hospital, Beijing

102206

Peking University International Hospital, Beijing

110001

The First Hospital of China Medical University, Shenyang

130021

The First Hospital of Jilin University, Changchun

200000

Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai

200233

Shanghai Sixth People's Hospital, Shanghai

221006

Jiangsu Province Hospital, Suzhou

266000

Qilu Hospital of Shandong University, Jinan

300020

Institute of Hematology and Blood Disease Hospital, Chinese Academy of Medical, Tianjin

300052

Tianjin Medical University General Hospital, Tianjin

310003

The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou

310009

The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou

361003

The First Affiliated Hospital of Xiamen University, Xiamen

400016

The First Affiliated Hospital of Chongqing Medical University, Chongqing

430022

Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology, Wuhan

450008

Henan Cancer Hospital, Zhengzhou

510000

Guangdong Provincial People's Hospital, Guangzhou

510280

Zhujiang Hospital Of Southern Medical University, Guangzhou

510515

Nanfang Hospital, Guangzhou

518020

Shenzhen Second People's Hospital, Shenzhen

550004

The Affiliated Hospital of Guizhou Medical University, Guiyang

650101

The second Affiliated Hospital of Kunming Medical University, Kunming

710004

The Second Affiliated Hospital of Xi'an Jiaotong University(Xibei Hospital), Xi’an

Unknown

Beijing Boren Hospital, Beijing

Sun Yat-sen University Cancer Center, Guangzhou

050000

The Second Hospital of HeBei Medical University, Shijiazhuang

All Listed Sponsors
lead

TJ Biopharma Co., Ltd.

INDUSTRY

NCT04202003 - A Study to Evaluate the Safety and Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of TJ011133 as Monotherapy and in Combination With Azacitidine (AZA) in Patients With Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS) | Biotech Hunter | Biotech Hunter