This study is to evaluate the safety and tolerability of EMB-09 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-09 will also be assessed.
This is a phase I, 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 for EMB-09 in patient with advanced or metastatic solid tumors. Pharmacokinetics,pharmacodynamics, immunogenicity and response will also be assessed.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
EMB-09 is a FIT-Ig® bispecific antibody against PD-L1 and OX40.
Peninsula and South Eastern Haematology & Oncology Group
Frankston, Australia
RECRUITINGGenesisCareNorthShore
Leonards Hill, Australia
RECRUITINGBlacktown Hospital
Sydney, 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-09 during treatment as a measure of tolerability.
Time frame: Screening up to 30 days after the las 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
Measured by RECIST 1.1.
Time frame: From the date of dosing until the date of first documented progression or date of death from any cause, whichever case first, expected average 6 months.
Area under the serum concentration-time curve (AUC) of EMB-09
Blood samples for serum PK analysis will be obtained (AUC).
Time frame: Through treatment until EOT visit, expected average 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
FUSCC
Shanghai, China
RECRUITINGMaximum serum concentration (Cmax) of EMB-09
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-09
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-09.
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-09
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-09
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-09
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-09 as assessed by RECIST 1
Preliminary anti-tumor activity of EMB-09 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-09
Antibodies to EMB-09 will be assessed to evaluate potential immunogenicity.
Time frame: Up to End of Treatment Follow Up Period (30 days after the last dose