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.
This is a Phase I/II, multi-center, open label, multiple-dose, first in human study, designed to assess safety and tolerability, and to identify the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) for EMB-06 in patients with relapsed or refractory multiple myeloma. Pharmacokinetics, pharmacodynamics, immunogenicity, and response will also be assessed.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
EMB-06 is a FIT-Ig® bispecific antibody against BCMA and CD3.
Sunshine Coast Haematology and Oncology Clinic (SCHOC)
Buderim, Queensland, Australia
Epworth Healthcare
Richmond, Victoria, Australia
One Clinical Research (OCR)
Nedlands, Western Australia, Australia
Incidence and severity of adverse events
Incidence and severity of AE.
Time frame: Screening up to follow-up (30 days after the last dose)
Incidence of serious adverse events (SAE)
Incidence of SAE
Time frame: Screening up to follow-up (30 days after the last dose)
Incidence of dose interruptions.
Incidence of dose interruptions of EMB-06 during treatment as a measure of tolerability.
Time frame: Screening up to follow-up (30 days after the last dose)
Dose intensity
Actual amount of drug taken by patients divided by the planned amount.
Time frame: Screening up to follow-up (30 days after the last dose)
The incidence of DLTs during treatment.
The Dose Limiting Toxicities (DLTs) are based on drug related adverse events and are specifically defined in study protocol.
Time frame: First infusion to the end of Cycle 1 (each cycle is 28 days)
Overall Response Rate (ORR)
Measured by IMWG criteria, only applicable in Phase II part
Time frame: From the date of dosing until the date of first documented progression or date of death from any cause, whichever came first, expected average 6 months
Area under the serum concentration-time curve (AUC) of EMB-06.
Blood samples for serum PK analysis will be obtained (AUC).
Time frame: Through treatment until EOT visit, expected average 6 months
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Beijing Jishuitan Hospital
Beijing, Beijing Municipality, China
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
Peking University, Third Hospital
Beijing, China
Guangdong Provincial People's Hospital
Guangzhou, China
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, China
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China
Henan Cancer Hospital
Zhengzhou, China
Maximum serum concentration (Cmax) of EMB-06.
Blood samples for serum PK analysis will be obtained (Cmax).
Time frame: Through treatment until EOT visit, expected average 6 months
Trough concentration (Ctrough) of EMB-06.
Blood samples for serum PK analysis will be obtained (Ctrough).
Time frame: Through treatment until EOT visit, expected average 6 months
Average concentration over a dosing interval (Css, avg) of EMB-06.
Blood samples for serum PK analysis will be obtained (Css, avg).
Time frame: Through treatment until EOT visit, expected average 6 months
Terminal half-life (T1/2) of EMB-06.
Blood samples for serum PK analysis will be obtained (T1/2).
Time frame: Through treatment until EOT visit, expected average 6 months
Systemic clearance (CL) of EMB-06.
Blood samples for serum PK analysis will be obtained (CL).
Time frame: Through treatment until EOT visit, expected average 6 months
Steady state volume of distribution (Vss) of EMB-06.
Blood samples for serum PK analysis will be obtained (Vss).
Time frame: Through treatment until EOT visit, expected average 6 months
Progression free survival (PFS) of EMB-06 as assessed by IMWG criteria.
Preliminary anti-multiple myeloma activity of EMB-06 will be obtained (PFS).
Time frame: From the date of dosing until the date of first documented progression or date of death from any cause, whichever came first, expected average 6 months
Duration of response of EMB-06 as assessed by IMWG criteria
Preliminary anti-multiple myeloma activity of EMB-06 will be obtained (DOR).
Time frame: From the date of dosing until the date of first documented progression or date of death from any cause, whichever came first, expected average 6 months
Incidence and titer of anti-drug antibodies stimulated by EMB-06.
Antibodies to EMB-06 will be assessed to evaluate potential immunogenicity.
Time frame: Up to End of Treatment Follow Up Period (30 days after the last dose)