EMB-01 in Patients With Advanced/Metastatic Gastrointestinal Cancers

Inclusion Criteria:

Molecular Pre-screening Inclusion criteria

1. cMET amplification in tumor sample; OR

2. cMET overexpression in tumor sample; OR

3. EGFR overexpression in tumor sample; OR

4. Other EGFR or cMET gene alteration in blood sample (circulating tumor DNA, ctDNA).

In Phase II, CRC patients must provide blood sample for NGS test, but may not provide tumor samples at prescreening visit. CRC patients don't need to meet the above criteria of EGFR/cMET amplification, overexpression or gene aberration.

Screening Inclusion Criteria

1. Able to understand and willing to sign the Informed Consent Form (ICF).

2. Histologically/cytologically confirmed advanced/metastatic gastric cancer, HCC, BTC,and colorectal cancer with measurable disease (RECIST V1.1). To be eligible,patients must meet following criteria:

3. Have failed all standard of care therapies known to confer clinical benefit.Patients who is not tolerable on standard of care therapies, or no standard ofcare therapies available, or refused standard of care therapies are eligible.

4. Have measurable disease as defined by RESIST v 1.1.

5. Archival tumor tissue (formalin-fixed or paraffin-embedded, collected within 1 year)or a new biopsy collected in the molecular pre-screening visit.

6. Must have adequate organ function.

7. Regarding prior anti-tumor therapy:

8. Patients who have received any anticancer drugs approved or investigational,including chemotherapy, immune therapy, hormonal therapy (Exceptions:hormone-replacement therapy, testosterone or oral contraceptives), biologictherapy, must have stopped treatment at least 4 weeks or within 5 half -liveswhichever shorter before first dose of EMB-01.

9. Local radiotherapy or radiation therapy for bone metastases must have stopped 2weeks before first dose of EMB-01. No therapeutic radiopharmaceuticals aretaken within 8 weeks before first dose of EMB-01.

10. Patients who have received prior targeted therapies must have stopped treatmentfor at least 4 weeks or within 5 half-lives, whichever is shorter before firstdose of EMB-01.

11. Female patient with fertility or male patient whose partner has fertility should useone or more contraceptive methods for contraception starting from screening periodand continue throughout the study treatment and for 3 months.

12. ECOG score ≤1.

Exclusion Criteria:

Molecular Pre-screening Exclusion Criteria

Subject who meets any of the following criteria can't be proceeded to clinical screening:

1. Patients who are unwilling to sign the molecular pre-screening ICF.

2. Patients for whom the results of central laboratory testing do not meet themolecular pre-screening inclusion criteria.

3. Patients with a documented gene alteration including but not limited to HER2, KRAS,NRAS, BRAF, NTRK, ALK, RET, ROS1, and FGFR, etc. that is known to confer resistanceto EGFR and/or cMET inhibitors.* * In Phase II, CRC patients with activated KRAS,NRAS or BRAF mutation should be excluded, but patients with other gene alterationsdo not need to be excluded.

Screening Exclusion Criteria

1. Life expectancy < 3 months.

2. Patients with primary central nervous system (CNS) malignancy or symptomatic CNS (leptomeningeal or brain) metastases are not allowed. Patients with asymptomatic CNSmetastases are eligible.

3. Pregnant or nursing females.

4. Patients who have had major surgery within the 28 days from the screening. Surgicalwounds must be completely healed.

5. Any other serious underlying medical (e.g. uncontrolled diabetes mellitus, activeuncontrolled infection, active gastric ulcer, uncontrolled seizures, cerebrovascularincidents, gastrointestinal bleeding, severe signs and symptoms of coagulation andclotting disorders, cardiac conditions), psychiatric, psychological, familial orgeographical condition that, in the judgment of the investigator, may interfere withthe planned staging, treatment and follow-up, affect patient compliance or place thepatient at high risk from treatment-related complications.