A Study of EMB-02 in Participants With Advanced Solid Tumors

A Phase I/II Trial of EMB-02, a Bi-specific Antibody Against PD-1 and LAG-3, in Patients With Advanced Solid Tumors

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.

Inclusion Criteria:

• Willing and able to provide written informed consent.
• Phase I: Patients with histologically or cytologically confirmed locally advanced/metastatic solid tumors and have failed (progressed on, or are intolerant of) standard therapies. Moreover, the disease should be measurable or evaluable per RECIST v1.1
• Phase II Cohort A: Patients with histologically or cytologically confirmed locally advanced/metastatic melanoma, excluding uveal melanoma. > 1 prior therapy, including prior treatment with PD-1/L1(mandatory) and/or CTLA-4 inhibitors(optional). And the disease is measurable or evaluable per RECIST v1.1
• Archival tumor samples available for retrospective analysis or biopsy will be taken.
• ECOG performance status 0 or 1 for phase I, and ≤2 for phase II; life expectancy > 3 Months
• Adequate organ function to participate in the trial.
• Recovery from adverse events (AEs) related to prior anticancer therapy.
• Highly effective contraception

Exclusion Criteria:

• Patients who have active autoimmune disease or history of autoimmune disease
• History of severe irAE.
• History of severe allergic reactions
• Use of systemic corticosteroids.
• Symptomatic central nervous system metastases.
• Patients with cardiac dysfunction
• Uncontrolled diabetes mellitus with hemoglobin A1c > 8% (via medical history)
• Prior treatment with a LAG-3 inhibitor
• Anticancer therapy or radiation < 5 half-lives or 4 weeks (whichever is shorter) prior to study treatment;
• Prior organ or stem cell/bone marrow transplant.
• Concurrent malignancy < 5 years prior to entry.
• Patients with active infections.
• Major surgery < 4 weeks or minor surgery < 2 weeks prior to study treatment
• Live virus vaccines < 30 days prior to screening
• Pregnant or breast-feeding females
• Any investigational agents or study drugs from a previous clinical study within 30 days of the first dose of study treatment
• Any other serious underlying medical conditions
• Abuse on alcohol, cannabis- derived products or other drugs