For solid tumors and lymphoma, respectively: This study is to evaluate the safety and tolerability of EMB-07 and to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D). Pharmacokinetics (PK), immunogenicity, and the anti-multiple myeloma activity of EMB-07 will also be assessed.
This is a phase I, multicenter, open label, dose escalation, first in human study, designed to assess safety and tolerability, and to identify the maximum tolerated dose (MTD) and/or recommended Phase 2 dose for EMB-07 in patient with locally advanced/metastatic solid tumors or relapse/refractory Lymphoma . Pharmacokinetics, pharmacodynamics, immunogenicity and response will also be assessed.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
EMB07 is a MAT-Fab bispecific antibody against CD3 and RORI
Peninsula and South Eastern Haematology and Oncology Group
Frankston, Victoria, Australia
RECRUITINGOne Clinical Research
Nedlands, Western Australia, Australia
RECRUITINGIncidence and severity of adverse events as assessed by CTCAE V5.0.
Incidence and severity of AE.
Time frame: Screening up to 30 days after the last dose.
Incidence of serious adverse events (SAE).
Incidence of SAE.
Time frame: Screening up to 30 days after the last dose, or beyond 30 days if SAE is confirmed to be treatment related.
Incidence of dose interruptions.
Incidence of dose interruptions of EMB-07 during treatment as a measure of tolerability.
Time frame: Screening up to 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 30 days after the last dose.
The incidence of DLTs during the first cycle of treatment.
The dose limiting toxicities 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.
Overall response rate measured by RECIST V1.1, iWCLL-2018, Lugano 2014
Time frame: From the date of dosing untill the date of first documented progression or date of death from any casue, whichever case first, expected average 6 months.
Area under the serum concentration-time curve (AUC) of EMB-07.
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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Hunan Cancer Hospital
Changsha, Hunan, China
RECRUITINGAffiliated Hospital of Hebei University
Baoding, China
RECRUITINGCancer Hospital Chinese Academy of Medical Sciences
Beijing, China
RECRUITINGThe First Affiliated Hospital of Bengbu Medical College
Bengbu, China
RECRUITINGZhujiang Hospital of Southern Medical University
Guangzhou, China
RECRUITINGThe Affiliated Tumour Hospital of Harbin Medical University
Harbin, China
RECRUITINGShandong Cancer Hospital
Shandong, China
RECRUITINGTianjin Medical University Cancer Institue & Hospital
Tianjin, China
RECRUITINGMaximum serum concentration (Cmax) of EMB-07.
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-07.
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-07.
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-07.
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-07.
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-07.
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-07 as assessed by RECIST 1.1, iWCLL-2018, Lugano 2014
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.
Time frame: Through treatment discontinuation: an average of 6 months
Incidence and titer of anti-drug antibodies stimulated by EMB-07.
Antibodies to EMB-07 will be assessed to evaluate potential immunogenicity.
Time frame: Up to End of Treatment Follow Up Period (30 days after the last dose)