The primary purpose of this study is to identify the recommended Phase 2 dose(s) (RP2Ds) and schedule assessed to be safe for EMB-02 and to characterize the safety and tolerability of EMB-02 at the RP2Ds. Pharmacokinetics (PK), immunogenicity, and the anti-tumor activity of EMB-02 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 dos(s)e (RP2D\[s\]) for EMB-02 in patients with advanced solid tumors. Pharmacokinetics, pharmacodynamics, immunogenicity, and response will also be assessed.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
47
EMB-02 is a FIT-Ig® bispecific antibody against PD-1 and LAG-3.
University of Colorado Health Medical Group
Colorado Springs, Colorado, United States
Prisma Health-Upstate
Greenville, South Carolina, United States
Southern Medical Day Care Centre
Wollongong, New South Wales, Australia
Incidence and severity of adverse events as assessed by CTCAE V5.0
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-02 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 the first cycle of 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)
Antitumor activity(Objective Response Rate (ORR)
Measured by RECIST 1.1, 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-02
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.
Monash Health
Clayton, Victoria, Australia
Peninsula & South Eastern Haematology & Oncology Group (PASO)
Frankston, Victoria, Australia
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
The first Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
HanDan Central Hospital
Handan, Hebei, China
HeNan Provincial People's Hospital
Zhengzhou, Henan, China
SuiNing Central Hospital
Suining, Sichuan, China
Maximum serum concentration (Cmax) of EMB-02
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-02
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-02.
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-02
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-02
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-02
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-02 as assessed by RECIST 1.1
Preliminary anti-tumor activity of EMB-02 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-02 as assessed by RECIST 1.1
Preliminary anti-tumor activity of EMB-02 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-02
Antibodies to EMB-02 will be assessed to evaluate potential immunogenicity.
Time frame: Up to End of Treatment Follow Up Period (30 days after the last dose)