SG301 Safety Study in Subjects With Relapsed or Refractory Multiple Myeloma and Other Hematological Malignancies
Condition(s) studied
Investigational drug(s) / intervention(s)
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.
Study 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
Eligibility
Primary outcome measure(s)
- Incidence of Treatment-Emergent Adverse Events — Through study completion, an average of one year
Number and percentage of AE which is calculated by worst CTCAE grade by CTCAE 5.0 - MTD/MAD/ RP2D — Through study completion, an average of one year
To determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) for intravenous (IV) administration of SG301 in patients with relapsed or refractory multiple myeloma and other hematological malignancies; To preliminarily determine the recommended Phase 2 dose (RP2D) of SG301 given intravenously in patients with relapsed or refractory multiple myeloma and other hematological malignancies.
Trial sites (14)
| Facility | City | Region | Status |
|---|---|---|---|
| The First Affiliated Hospital of Bengbu Medical College | Bengbu | Anhui | |
| Affiliated Beijing Chaoyang Hospital of Capital Medical University | Beijing | Beijing Municipality | |
| Beijing Jishuitan Hostipal | Beijing | Beijing Municipality | |
| Shenzhen Second People's Hospital | Shenzhen | Guangzhou | |
| The Fourth Affiliated Hospital of Hebei Medical University | Shijiazhuang | Hebei | |
| Henan Cancer Hospital | Zhengzhou | Henan | |
| Wuhan University Central South Hospital | Wuhan | Hubei | |
| Xiangyang Central Hospital | Xiangyang | Hubei | |
| Wuxi Central Hospital | Wuxi | Jiangsu | |
| The First Affiliated Hospital of China Medical University | Shenyang | Liaoning | |
| Shengjing Hospital Affiliated to China Medical University | Shenyang | Liaoning | |
| Qilu Hospital of Shandong University | Jinan | Shandong | |
| Shanxi Norman Bethune Hospital | Taiyuan | Shanxi | |
| The Second Affiliated Hospital of Zhejiang University School of Medicine | Hangzhou | Zhejiang |
More Hangzhou Sumgen Biotech Co., Ltd. trials in China
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04684108 on ClinicalTrials.gov ↗ ← All trials in China