A Dose Escalation Study of EMB-01 in Participants With Advanced/Metastatic Solid Tumors

This is a first-in-human (FIH), open-label, Phase I/II study of EMB-01, a bispecific
Epidermal growth factor receptor (EGFR) and c-Mesenchymal-Epithelial Transition (cMet)
antibody, in patients with advanced solid tumors who have progressed on available standard
therapies or for which no standard therapy exists. The study consists of two parts: Phase I
(dose escalation) and Phase II (cohort expansion). The study is planning to recruit
tentatively 33-66 subjects with advanced/metastatic solid tumors in phase I and about 40
patients with EGFR mutant Non-Small Cell Lung Cancer (NSCLC) in Phase II. Both parts consist
of screening period (-28 to -1 days), treatment cycles (each cycle is 28 days), and follow-up
period (30 days safety follow up and disease progression follow up).

Inclusion Criteria:

- Histologically/cytologically confirmed advanced/metastatic solid tumors with
measurable disease [Response Evaluation Criteria in Solid Tumors (RECIST) v1.1]:

Phase I: advanced/metastatic solid tumors refractory to standard therapy or for which no
standard therapy is available or accessible Phase II: Patients with EGFR mutant NSCLC
progressed after treatment with EGFR Tyrosine kinase inhibitor(s) [TKI(s)] or patients with
EGFR mutation but are intolerant to EGFR TKI(s) treatment.

- Have adequate organ function.

- Prior anti-tumor therapy:

1. Must have stopped any anticancer drug treatment at least 4 weeks or within 5 half
-lives .

2. Generalized radiation therapy must have stopped 3 weeks except for local
radiotherapy or radiation therapy for bone metastases which must have stopped 2
weeks before first dose of EMB-01. No therapeutic radiopharmaceuticals are taken
within 8 weeks before study treatment.

- Eastern Cooperative Oncology Group (ECOG) score 0 or 1 for phase I, and ≤2 for phase
II.

Exclusion Criteria:

- Life expectancy < 3 months.

- Subject with primacy central nervous system (CNS) malignancy or symptomatic CNS
(leptomeningeal or brain) metastases.

- Pregnant or nursing females.

- Subjects who have had major surgery within the 28-days.

- Serious underlying medical conditions, including but not limited to un-controlled
hypertension, other cardiovascular disease or diabetes, ongoing or active infection,
psychiatric, psychological, familial or geographical condition that, in the judgment
of the investigator, may interfere the compliance with study treatment.