SG301 IV / Sumgen Biotech - LARVOL DELTA

SG301, a Novel Anti-CD38 Monoclonal Antibody, in Patients with Relapsed/Refractory Multiple Myeloma: A First-in-Human, Multicentre, Phase 1 Trial (ASH 2024) - "SG301 is a novel humanized IgG1-kappa monoclonal antibody that binds CD38 via a unique epitope distinct from that of other anti-CD38 antibodies including daratumumab and isatuximab. SG301 8 mg/kg demonstrated preliminary promising clinical efficacy with the target occupancy continuously saturated. Further studies are ongoing and planned."

Clinical • First-in-human • IO biomarker • P1 data • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukopenia • Multiple Myeloma • Nephrology • Neutropenia • Oncology • Respiratory Diseases • Thrombocytopenia

CSG-301-101: SG301 Safety Study in Subjects With Relapsed or Refractory Multiple Myeloma and Other Hematological Malignancies (clinicaltrials.gov) - P1 | N=61 | Active, not recruiting | Sponsor: Hangzhou Sumgen Biotech Co., Ltd. | Trial completion date: Dec 2024 ➔ Jun 2026

Trial completion date • Hematological Disorders • Hematological Malignancies • Multiple Myeloma • Oncology • CD38

A Clinical Study Comparing SG301 Plus Pomalidomide and Dexamethasone to Placebo Plus Pomalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma Patients (clinicaltrials.gov) - P3 | N=360 | Recruiting | Sponsor: Hangzhou Sumgen Biotech Co., Ltd.

Combination therapy • New P3 trial • Hematological Malignancies • Multiple Myeloma • Oncology

SG301 Safety Study in Subjects With Relapsed or Refractory Multiple Myeloma and Other Hematological Malignancies (clinicaltrials.gov) - P1 | N=61 | Active, not recruiting | Sponsor: Hangzhou Sumgen Biotech Co., Ltd. | Withdrawn ➔ Active, not recruiting | Trial completion date: Oct 2022 ➔ Dec 2024 | Trial primary completion date: Sep 2022 ➔ Jun 2024

Enrollment closed • Trial completion date • Trial primary completion date • Hematological Disorders • Hematological Malignancies • Multiple Myeloma • Oncology • CD38

SG301-SC Injection Safety Study in Subjects With Systemic Lupus Erythematosus (clinicaltrials.gov) - P1 | N=48 | Recruiting | Sponsor: Hangzhou Sumgen Biotech Co., Ltd.

New P1 trial • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

SG301 Safety Study in Subjects With Relapsed or Refractory Multiple Myeloma and Other Hematological Malignancies (clinicaltrials.gov) - P1 | N=0 | Withdrawn | Sponsor: Hangzhou Sumgen Biotech Co., Ltd. | N=108 ➔ 0 | Not yet recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • Hematological Disorders • Hematological Malignancies • Multiple Myeloma • Oncology • CD38