NCT04684108

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

A Phase 1 Study of SG301 in Subjects With Hematological Malignancies

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Hangzhou Sumgen Biotech Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

After a screening period of up to 28 days for each study phase, qualified patients will be enrolled to receive their assigned dose of SG301, administered weekly for the first 2 cycles and every 2 weeks thereafter, until disease progression or intolerable toxicity, starting of a new anticancer treatment, withdrawal of consent, lost to follow up, death, or end of the study, whichever occurs first. The study consists of a dose escalation phase (Phase 1a) and a dose expansion phase (Phase 1b) in subjects with relapsed or refractory multiple myeloma and other hematological malignancies.

Conditions

• Relapsed or Refractory Multiple Myeloma
• Hematological Malignancy

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-11-04
• Primary completion: 2024-06-30
• Completion: 2026-06-30
• First posted: 2020-12-24
• Last updated: 2026-04-07

Locations

14 sites across 1 country: China

Regulatory

• FDA-regulated drug study