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SG301 Safety Study in Subjects With Relapsed or Refractory Multiple Myeloma and Other Hematological Malignancies
Sponsor: Hangzhou Sumgen Biotech Co., Ltd.
Summary
This is a Phase 1a/1b Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SG301 in Patients with Relapsed or Refractory Multiple Myeloma and Other Hematological Malignancies
Official title: A Phase 1 Study of SG301 in Subjects With Hematological Malignancies
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
61
Start Date
2021-11-04
Completion Date
2026-06-30
Last Updated
2026-04-07
Healthy Volunteers
No
Interventions
SG301
Phase 1a will use an accelerated titration and 3+3 design with 9 dose cohorts: 0.005 mg/kg, 0.05 mg/kg,0.5 mg/kg, 1 mg/kg, 2 mg/kg, 4 mg/kg, 8 mg/kg, 12 mg/kg and 16 mg/kg by IV infusion. Accelerated titration (i.e., 1 patient each) will be applied to the first 3 cohorts.
Locations (14)
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China
Affiliated Beijing Chaoyang Hospital of Capital Medical University
Beijing, Beijing Municipality, China
Beijing Jishuitan Hostipal
Beijing, Beijing Municipality, China
Shenzhen Second People's Hospital
Shenzhen, Guangzhou, China
The Fourth Affiliated Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Wuhan University Central South Hospital
Wuhan, Hubei, China
Xiangyang Central Hospital
Xiangyang, Hubei, China
Wuxi Central Hospital
Wuxi, Jiangsu, China
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, China
Shengjing Hospital Affiliated to China Medical University
Shenyang, Liaoning, China
Qilu Hospital of Shandong University
Jinan, Shandong, China
Shanxi Norman Bethune Hospital
Taiyuan, Shanxi, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China