NCT05293912

SG2501 Safety Study in Subjects with Relapsed or Refractory Hematological Malignancies and Lymphoma.

A Phase Ia/Ib, First-in-Human, Open-Label, Multicenter, Dose Escalation and Dose Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Preliminary Efficacy of SG2501 in Subjects with Relapsed or Refractory Hematological Malignancies and Lymphoma.

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Hangzhou Sumgen Biotech Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase Ia/Ib, first-in-Human, open-Label, multicenter, dose escalation and dose expansion study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary efficacy of SG2501 in subjects with relapsed or refractory hematological malignancies and lymphoma.

Detailed description

Phase Ia will consist of two parts:an accelerated titration using single patient cohorts to evaluate SG2501 at lower dose levels(Part A), followed by dose-escalation using multipatient cohorts to establish a maximum tolerated dose(MTD)(Part B). Phase Ib will consist of dose expansion cohorts with SG2501 monotherapy in subjects with relapsed or refractory multiple myeloma(MM) or diffuse large B-cell lymphoma(DLBCL).

Conditions

• Hematological Malignancy
• Lymphoma

Interventions

Type	Name	Description
DRUG	SG2501	During study treatment, subjects will receive SG2501 treatment via IV infusion once every week at doses of: 0.01, 0.03, 0.1, 0.3, 1, 2, 4 and 6mg/kg.

Timeline

• Start date: 2023-03-03
• Primary completion: 2023-06-30
• Completion: 2023-06-30
• First posted: 2022-03-24
• Last updated: 2025-03-18

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study