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ACTIVE NOT RECRUITING
NCT04684108
PHASE1

SG301 Safety Study in Subjects With Relapsed or Refractory Multiple Myeloma and Other Hematological Malignancies

Sponsor: Hangzhou Sumgen Biotech Co., Ltd.

View on ClinicalTrials.gov

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

DRUG

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