EMB-01 in Patients With Advanced/Metastatic Gastrointestinal Cancers

• Status: Recruiting
• Trial end date: 2024-08-31
• Target enrollment: 0
• Participant gender: All

Summary

This study is to evaluate the safety and antitumor activity of EMB-01 in advanced/metastatic gastrointestinal cancers, including gastric cancer, hepatocellular cancer, cholangiocarcinoma and colorectal cancer.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai EpimAb Biotherapeutics Co., Ltd.
• Collaborator: Covance

Criteria

Inclusion Criteria:

Molecular Pre-screening Inclusion criteria (Phase II only)

1. cMET amplification in tumor sample: cMET gene copy number ≥5 or MET/CEP7 ratio ≥ 2 by FISH; OR

2. cMET overexpression in tumor sample: cMET expression ≥ 2+ by IHC, OR

3. EGFR overexpression in tumor sample: EGFR expression ≥ 3+ by IHC; OR

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

point mutation causing activation of EGFR or cMET tyrosine kinase, insertion/deletion (indels), copy number amplification by NGS.

Screening Inclusion Criteria

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

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

1. 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 of care therapies available, or refused standard of care therapies are eligible.

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

3. Must have adequate organ function.

4. Regarding prior anti-tumor therapy:

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

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

3. Patients who have received prior targeted therapies must have stopped treatment for at least 4 weeks or within 5 half-lives, whichever is shorter before first dose of EMB-01.

5. Female patient with fertility or male patient whose partner has fertility should use one or more contraceptive methods for contraception starting from screening period and continue throughout the study treatment and for 3 months.

6. ECOG score ≤2.

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 the molecular pre-screening inclusion criteria.

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 CNS metastases are eligible.

3. Pregnant or nursing females.

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

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