Relapsed/Refractory Multiple Myeloma
Conditions
Brief summary
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
DRUGSG2918
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.
Sponsors
Hangzhou Sumgen Biotech Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 years and ≤ 80 years. 2. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2. 3. Life expectancy ≥ 3 months. 4. Documented diagnosis of multiple myeloma. 5. Measurable disease at screening (per IMWG criteria). 6. Relevant laboratory values obtained within 7 days prior to the first dose must meet protocol-specified thresholds. 7. Resolution of adverse events related to prior antineoplastic therapy to Grade ≤ 1 or baseline (CTCAE v6.0). 8. 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. 9. 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
1. Patients with primary refractory multiple myeloma. 2. Presence of non-bone-related extramedullary soft tissue plasmacytoma at screening. 3. known meningeal or Central Nervous System involvement of multiple myeloma, or high suspicion of unconfirmed meningeal or Central Nervous System involvement. 4. History of peripheral neuropathy of Grade ≥ 2. 5. Active infection requiring systemic therapy within 2 weeks prior to the first dose. 6. Hypertension that was not effectively controlled by standardized antihypertensive treatment within 2 weeks prior to the first dose, as judged by the investigator 7. History of hypertensive crisis or hypertensive encephalopathy. 8. Poorly controlled diabetes mellitus. 9. Severe cardiovascular or cerebrovascular disease within 6 months prior to the first dose. 10. Active hepatitis B or hepatitis C infection. 11. Known history of active tuberculosis or active syphilis. 12. Known hypersensitivity to any component of the investigational product. 13. history of Grade 3-4 allergic reaction or life threatening hypersensitivity to any biological product. 14. Received any of the following therapies or surgeries. 1. Prior treatment with LILRB4 targeted therapy; or severe adverse reaction to prior MMAE containing therapy. 2. Immunotherapy, macromolecular targeted therapy, or other antineoplastic biologic therapy within 28 days prior to the first dose. 3. Cytotoxic chemotherapy or small molecule therapy within 14 days prior to the first dose. 4. Modernized traditional Chinese herbal medicine with approved antineoplastic indications within 7 days prior to the first dose. 15. 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. 16. Administration of any live or live attenuated vaccine within 28 days prior to the first dose. 17. Administration of other vaccines (e.g., inactivated COVID-19 vaccine) within 14 days prior to the first dose. 18. Immune related toxicity during prior antineoplastic immunotherapy that resulted in permanent treatment discontinuation. 19. Current or previous idiopathic pulmonary fibrosis or idiopathic pneumonia; 20. Current acute pulmonary disease, interstitial lung disease, or pneumonia. 21. Any other malignancy diagnosed within 5 years prior to the first dose. 22. Documented history of neurological or psychiatric disorder. 23. Any other condition that, in the opinion of the investigator, may render the participant unsuitable for study participation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events（AEs ） | From time Day1 of Cycle1 until 30 days after last dose of SG2918 | Number and percentage of AEs which is calculated by worst CTCAE grade by CTCAE 6.0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics(PK): Cmax | Through study completion, an average of one year | Maximum drug concentration after administration |
| Pharmacokinetics (PK): T1/2 | Elimination half-life of the drug after administration | Elimination half-life of the drug after administration |
| Pharmacokinetics (PK): AUC | Through study completion, an average of one year | Area Under the Curve of the drug after administration |
| Immunogenicity | Through study completion, an average of one year | Levels of anti-drug antibodies(ADAs) and neutralizing antibodies (tested in ADA-positive samples) |
| objective response rate(ORR) | Through study completion, an average of one year | percentage of participants with stringent complete response (sCR), complete response (CR), very good partial response (VGPR), and partial response (PR) as best overall response |
| PFS | Through study completion, an average of one year | Progression-Free Survival |
| MRD | Through study completion, an average of one year | assessed by next-generation sequencing in bone marrow samples from participants who achieved CR or sCR, to determine the depth of response at the molecular level. |
Countries
China
Contacts
CONTACTYue Song
Outcome results
None listed