Overview

A Study to Evaluate the Efficacy and Safety of MRG003 in Patients With Advanced Gastric Cancer.

Status:
Recruiting
Trial end date:
2023-08-01
Target enrollment:
0
Participant gender:
All
Summary
The objective of this study is to assess the safety, efficacy, pharmacokinetics, and immunogenicity of MRG003 in patients with EGFR-positive, HER2-negative, inoperable locally advanced or metastatic gastric cancer.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Shanghai Miracogen Inc.
Criteria
Inclusion Criteria:

- - Willing to sign the ICF and follow the requirements specified in the protocol.

- Age: 18-75 years (including 18 and 75), both genders.

- Expected survival time≥3 months.

- Patients with histologically confirmed inoperable locally advanced or metastatic
gastric adenocarcinoma.

- Tumor tissue must be EGFR positive and HER2 negative.

- Patients must have measurable lesions according to the Response Evaluation Criteria in
Solid Tumors (RECIST v1.1).

- ECOG performance score 0 or 1.

- Organ functions and coagulation function must meet the basic requirements.

- No severe cardiac dysfunction with left ventricular ejection fraction (LVEF) ≥ 50%.

- Serum or urine pregnancy test negative within 7 days before the first dose of
investigational drug.

- Patients with childbearing potential must use effective contraception during the
treatment and for 6 months after the last dose of treatment.

Exclusion Criteria:

- - Squamous cell carcinoma, carcinoid, neuroendocrine carcinoma, undifferentiated
carcinoma, or other gastric cancers,or adenocarcinoma with other pathological
components that cannot be classified, or adenocarcin oma accompanied by other
pathological components.

- History of hypersensitivity to any component of the study drug or to other
EGFR-targeting agents.

- Antitumor biological therapy or immunotherapy, targeted small molecule therapy and
have history of systemic chemotherapy within 4 weeks before the first administration
of the investigational drug, or major surgery. Traditional Chinese medicine, Chinese
patent medicine or traditional Chinese medicine formula with anti-tumor effect should
not be used within 2 weeks before the first administration.

- Potent CYP3A4 inhibitors or inducers are in use and cannot be discontinued.

- Known active CNS metastasis.

- Uncontrolled pleural effusion, pericardial effusion or recurrent ascites.

- Patients with intestinal obstruction requiring treatment were excluded.

- Residual toxicity reactions caused by previous anti-tumor treatment or abnormal values
of laboratory tests higher than grade 1 (CTCAE v5.0).

Peripheral neuropathy ≥ Grade 2 (NCICTCAE version 5.0).

- Uncontrolled or poorly controlled hypertension.

- Uncontrolled or poorly controlled heart disease.

- Known active hepatitis B or C.

- Active bacterial, viral, fungal, rickettsia, or parasitic infections that require
systemic anti-infective treatment.

- Known history of malignancy.

- History of ophthalmologic abnormalities

- History of severe skin disease

- Moderate to severe dyspnea at rest caused by advanced cancer or its complications, or
severe primary lung disease, oxygen saturation < 93% in non-oxygen state, or history
of any interstitial lung disease or interstitial lung disease (ILD) requiring oral or
intravenous glucocorticoids or non-infectious pneumonia.

- Patients with a history of active bleeding, coagulopathy, or receiving coumarin
anticoagulation therapy.

- History of pulmonary embolism or deep vein thrombosis within 6 months before the first
administration of the investigational drug.

- Patients with a history of active bleeding, coagulopathy, or receiving coumarin
anticoagulation therapy.

Decompensated cirrhosis of Child-Pugh class B, C

- Complicated with severe, uncontrolled infection or known human immunodeficiency virus
(HIV) infection, or diagnosed as acquired immunodeficiency syndrome (AIDS); or
uncontrolled autoimmune disease; or history of allogeneic tissue/organ
transplantation, stem cell or bone marrow transplantation, or solid organ
transplantation.

- Vaccination of live virus vaccine within 30 days before the first administration of
the study drug. Inactivated seasonal influenza vaccine or approved COVID-19 vaccine is
allowed.

- Uncontrolled intercurrent illness

- Patients requiring parenteral nutrition within 4 weeks

- Women who are lactating or pregnant.

- Other conditions that in the clinical judgement of the investigator make the patient
not suitable for participation in this study.