The primary purpose of this study is to evaluate safety and tolerability profile of EMB-15, identify the recommended Phase 2 dose(s) (RP2Ds) for EMB-15. Pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and the anti-tumor activity of EMB-15 will also be assessed.
None
Any prior ALPP/ALPG targeting therapy
Has received anticancer therapy, radiotherapy, or investigational drug within < 5 half-lives or 4 weeks (whichever is shorter) prior to study treatment;
Active autoimmune disease or history of autoimmune disease
Concurrent malignancy < 5 years prior to study entry
Sequential
EMB-15
Biological/VaccineEMB-15 is a recombinant humanized bi-specific antibody against ALPP/ALPG and CD3
incidence and severity of adverse events as assessed by CTCAE v6.0 and ASTCT.
Incidence and severity of AE.
Incidence of serious adverse events (SAE)
Incidence of SAE.
Incidence of dose interruptions
Incidence of dose interruptions of EMB-15 during treatment as a measure of tolerability.
Dose intensity
Actual amount of drug taken by patients divided by the planned amount.
Area under the serum concentration-time curve (AUC) of EMB-15
Blood samples for serum PK analysis will be obtained (AUC).
Maximum serum concentration (Cmax) of EMB-15
Blood samples for serum PK analysis will be obtained (Cmax)
Trough concentration (Ctrough) of EMB-15
Blood samples for serum PK analysis will be obtained (Ctrough)
Average concentration over a dosing interval (Css, avg)of EMB-15
Blood samples for serum PK analysis will be obtained (Css, avg).
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