A Ph1/2 Study of EMB-06 in Participants With Relapsed or Refractory Myeloma
Reason given: Company's resource optimization and product's development change
Key facts
- Phase
- Phase 1/2
This trial has no sites in United States.
It has sites in 2 countries. Choose a country to see its sites.
Trial details
- Who runs it
- Shanghai EpimAb Biotherapeutics Co., Ltd.
- Trial code
- NCT04735575
- Record updated
- 28 May 2025
- Original description
The primary purpose of this study is to identify the recommended Phase 2 dose(s) (RP2Ds) and schedule assessed to be safe for EMB-06 and to characterize the safety and tolerability of EMB-06 at the RP2Ds. Pharmacokinetics (PK), immunogenicity, and the anti-multiple myeloma activity of EMB-06 will also be assessed.Read full original descriptionShow less
A First-in-human, Phase I/II, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of EMB-06 in Patients With Relapsed or Refractory Multiple Myeloma
The primary purpose of this study is to identify the recommended Phase 2 dose(s) (RP2Ds) and schedule assessed to be safe for EMB-06 and to characterize the safety and tolerability of EMB-06 at the RP2Ds. Pharmacokinetics (PK), immunogenicity, and the anti-multiple myeloma activity of EMB-06 will also be assessed.
Inclusion: Able to understand and willing to sign the informed consent form (ICF); Patients who have been diagnosed with multiple myeloma according to IMWG diagnostic criteria 2014 and have relapsed or refractory multiple myeloma with at least one measurable lesion; The patient must have received at least two lines (for patients in the US, at least three lines which should include anti-CD38 antibody) of prior antimyeloma therapies, and must have received treatment with proteasome inhibitors, immunomodulatory agents, and if accessible, an anti-CD38 targeting monoclonal antibody; ECOG performance status 0 or 1 for phase I, and ≤2 for phase II; Adequate organ function and reasonable laboratory test results to participate in the trial; Highly effective contraception.
Exclusion: Patient participated in any other clinical study within 1 month prior to enrollment in this clinical study; Previously treated with any BCMA-targeted therapy.(Exception: in Phase 2 portion, up to 10 patients who have received prior anti-BCMA ADC or BCMA targeted CAR-T can be enrolled); Previously treated with the following anti-tumor therapy (prior to first dosing of EMB-06); Treated with monoclonal antibody for multiple myeloma within 28 days; Treated with proteasome inhibitors within 14 days; Treated with immunomodulatory agents within 14 days; Treated with cytotoxic therapy within 14 days; Received investigational drug within 28 days or at least 5 half-lives, whichever is shorter (if a, b, c, d not applicable); Received radiotherapy within 21 days. Except that the radiation portal covered ≤ 5% of the bone marrow reserve, the patient will be eligible to participate in the study regardless of the end date of radiation therapy; Plasmapheresis within 7 days; Patient received autologous stem cell transplantation within 12 weeks prior to the start of study treatment; Patients requiring high dose of systemic treatment with corticosteroids; History of allogeneic stem cell transplantation; Patients with active infections, including COVID-19, hepatitis, etc; History of severe allergic reactions; Patients with severe or uncontrolled cardiovascular disorder requiring treatment; Pre-existing other serious medical conditions; Life expectancy is less than 3 months; Patients with ongoing AE; Active or historically multiple myeloma related central nervous system involvement.