To Evaluate the Safety of SG2918 in Patients With Relapsed/Refractory Multiple Myeloma

Official title

A Phase 1b/2 Clinical Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of SG2918 for Injection in Patients With Relapsed/Refractory Multiple Myeloma

Overview

The primary objective of this study was to evaluate the safety and tolerability of SG2918 in patients with relapsed/refractory multiple myeloma.

Detailed description

This is a multicenter, open-label, dose-escalation and dose-expansion Phase Ib/II clinical study of SG2918 conducted in Chinese patients with relapsed/refractory multiple myeloma.The primary objective of this study is to evaluate the safety and tolerability of SG2918 in patients with relapsed/refractory multiple myeloma.Secondary objectives include exploring the efficacy, pharmacokinetic profile, pharmacodynamics, and immunogenicity of SG2918.

Interventions

• Drug SG2918
  The study adopts a "3+3" dosing escalation approach. Initially, three dose groups are set, namely 1.5mg/kg, 1.8mg/kg, and 2mg/kg. The SG2918 will be administrated by intravenous infusion every 3 weeks.

Primary outcome measures

• Incidence of Treatment-Emergent Adverse Events（AEs ） [Time frame: From time Day1 of Cycle1 until 30 days after last dose of SG2918]

Secondary outcome measures (7)

• Pharmacokinetics(PK): Cmax [Time frame: Through study completion, an average of one year]
• Pharmacokinetics (PK): T1/2 [Time frame: Elimination half-life of the drug after administration]
• Pharmacokinetics (PK): AUC [Time frame: Through study completion, an average of one year]
• Immunogenicity [Time frame: Through study completion, an average of one year]
• objective response rate(ORR) [Time frame: Through study completion, an average of one year]
• PFS [Time frame: Through study completion, an average of one year]
• MRD [Time frame: Through study completion, an average of one year]

Eligibility criteria

Inclusion criteria

• Age ≥ 18 years and ≤ 80 years.
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
• Life expectancy ≥ 3 months.
• Documented diagnosis of multiple myeloma.
• Measurable disease at screening (per IMWG criteria).
• Relevant laboratory values obtained within 7 days prior to the first dose must meet protocol-specified thresholds.
• Resolution of adverse events related to prior antineoplastic therapy to Grade ≤ 1 or baseline (CTCAE v6.0).
• Female participants of childbearing potential and male participants whose partners are of childbearing potential must use at least one acceptable method of contraception during study treatment and for at least 7 months after the last dose.
• Male participants must refrain from sperm donation from the signing of the Informed Consent Form (ICF) until at least 7 months after the last study dose.

Exclusion criteria

• Patients with primary refractory multiple myeloma.
• Presence of non-bone-related extramedullary soft tissue plasmacytoma at screening.
• known meningeal or Central Nervous System involvement of multiple myeloma, or high suspicion of unconfirmed meningeal or Central Nervous System involvement.
• History of peripheral neuropathy of Grade ≥ 2.
• Active infection requiring systemic therapy within 2 weeks prior to the first dose.
• Hypertension that was not effectively controlled by standardized antihypertensive treatment within 2 weeks prior to the first dose, as judged by the investigator
• History of hypertensive crisis or hypertensive encephalopathy.
• Poorly controlled diabetes mellitus.
• Severe cardiovascular or cerebrovascular disease within 6 months prior to the first dose.
• Active hepatitis B or hepatitis C infection.
• Known history of active tuberculosis or active syphilis.
• Known hypersensitivity to any component of the investigational product.
• history of Grade 3-4 allergic reaction or life threatening hypersensitivity to any biological product.
• Received any of the following therapies or surgeries.

• Prior treatment with LILRB4 targeted therapy; or severe adverse reaction to prior MMAE containing therapy.
• Immunotherapy, macromolecular targeted therapy, or other antineoplastic biologic therapy within 28 days prior to the first dose.
• Cytotoxic chemotherapy or small molecule therapy within 14 days prior to the first dose.
• Modernized traditional Chinese herbal medicine with approved antineoplastic indications within 7 days prior to the first dose.
• Requirement for systemic corticosteroids (equivalent to > 10 mg prednisone per day) or other immunosuppressive agents within 14 days prior to the first dose or during the study.
• Administration of any live or live attenuated vaccine within 28 days prior to the first dose.
• Administration of other vaccines (e.g., inactivated COVID-19 vaccine) within 14 days prior to the first dose.
• Immune related toxicity during prior antineoplastic immunotherapy that resulted in permanent treatment discontinuation.
• Current or previous idiopathic pulmonary fibrosis or idiopathic pneumonia;
• Current acute pulmonary disease, interstitial lung disease, or pneumonia.
• Any other malignancy diagnosed within 5 years prior to the first dose.
• Documented history of neurological or psychiatric disorder.
• Any other condition that, in the opinion of the investigator, may render the participant unsuitable for study participation.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

China · 4 centers

• Henan Cancer Hospital — Zhengzhou
• The First Affiliated Hospital Of Soochow University — Suzhou
• The Second Affiliated Hospital Of Xi an Jiaotong University (Xibei Hospital) — Xi’an
• The Second Affiliated Hospital Zhejiang University School Of Medicine — Hangzhou

Identifiers

NCT: NCT07454187 · CSG-2918-102

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗