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)
- Conditions
- Acute Myeloid Leukemia (AML)Myelodysplastic Syndromes(MDS)
- Interventions
- Drug: TJ011133
- Registration Number
- NCT04202003
- Lead Sponsor
- TJ Biopharma Co., Ltd.
- Brief Summary
This study is a phase I/II study of TJ011133 as Monotherapy and in Combination with Azacitidine (AZA) in Patients with Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS). This study include Phase I and Phase IIa study. Phase I study ClinicalTrials.gov ID is NCT04202003 and this is for phase IIa study. Phase IIa study is designed to preliminarily assess the efficacy and safety of TJ011133 in combination with AZA as first-line treatment in patients with newly diagnosed AML who are intolerant to standard induction chemotherapy or patients with treatment naive, intermediate and high-risk MDS.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 105
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description TJ011133 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.
- Primary Outcome Measures
Name Time Method Complete response rate (CR rate) only for phase 2a Through study completion，an average of 1 year Preliminary efficacy endpoints (only for Phase 2a): for response assessment in AML/MDS patients, the complete response rate (CR rate) will be evaluated according to the ELN2017/IWG 2006 criteria
Dose Limiting Toxicities(DLT) 28days after first dose To evaluate the safety and tolerance of TJ011133 monotherapy in patients with r/r AML or MDS
Recommended phase II dose Through study completion, an average of 1 year Recommended phase II dose (RP2D)
Maximum tolerable dose(MTD) Through study completion, an average of 1 year To explore the maximum tolerable dose (MTD) of TJ011133 monotherapy for patients with r/r AML or MDS, the recommended phase II dose (RP2D) and the optimal dosage regimen.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (26)
The First Affiliated Hospital of Chongqing Medical University
🇨🇳Chongqing, Chongqing, China
The First Affiliated Hospital of Xiamen University
🇨🇳Xiamen, Fujian, China
The Second Hospital of HeBei Medical University
🇨🇳Shijiazhuang, Hebei, China
Jiangsu Province Hospital
🇨🇳Suzhou, Jiangsu, China
Qilu Hospital of Shandong University
🇨🇳Jinan, Shandong, China
Tianjin Medical University General Hospital
🇨🇳Tianjin, Tianjin, China
The Second Affiliated Hospital, Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China
Peking University International Hospital
🇨🇳Beijing, Beijing, China
Peking Union Medical College Hospital
🇨🇳Beijing, Beijing, China
Beijing Boren Hospital
🇨🇳Beijing, Beijing, China
Henan Cancer Hospital
🇨🇳Zhengzhou, Henan, China
Institute of Hematology and Blood Disease Hospital, Chinese Academy of Medical
🇨🇳Tianjin, Tianjin, China
Guangdong Provincial People's Hospital
🇨🇳Guangzhou, Guangdong, China
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
🇨🇳Shanghai, Shanghai, China
The Affiliated Hospital of Guizhou Medical University
🇨🇳Guiyang, Guizhou, China
Sun Yat-sen University Cancer Center
🇨🇳Guangzhou, Guangdong, China
Shenzhen Second People's Hospital
🇨🇳Shenzhen, Guangdong, China
The First Hospital of Jilin University
🇨🇳Changchun, Jilin, China
The Second Affiliated Hospital of Xi'an Jiaotong University（Xibei Hospital）
🇨🇳Xi'an, Shanxi, China
Shanghai Sixth People's Hospital
🇨🇳Shanghai, Shanghai, China
The second Affiliated Hospital of Kunming Medical University
🇨🇳Kunming, Yunnan, China
The First Affiliated Hospital, Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China
Nanfang Hospital
🇨🇳Guangzhou, Guangdong, China
Zhujiang Hospital Of Southern Medical University
🇨🇳Guangzhou, Guangdong, China
Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
🇨🇳Wuhan, Hubei, China
The First Hospital of China Medical University
🇨🇳Shenyang, Liaoning, China
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