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

NCT05188209 | Unknown Phase 2

• 1 other identifier: MRG003-006
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Advanced or Metastatic Gastric Cancer; Advanced or Metastatic Gastroesophageal Junction Carcinoma

Keywords

MRG003; Antibody Drug Conjugate (ADC); Gastric Cancer; EGFR-positive, HER2-negative

Outcome Measures

Primary Outcomes (2)

• Objective Response Rate (ORR) by Independent Review Committee (IRC)

  ORR is defined as the proportions of patients with a complete response (CR) and partial response (PR). ORR will be assessed by Independent Review Committee (IRC) according to RECIST v1.1.

  Baseline to study completion (up to 24 months)

• Adverse Events (AEs)

  Any reaction, side effect, or untoward event that occurs during the course of the clinical trial whether or not the event is considered related to the study drug.

  Baseline to 30(for AE) and 45(for SAE) days after the last dose of study treatment

Secondary Outcomes (12)

• Objective Response Rate (ORR) by Investigator

  Baseline to study completion (up to 24 months)

• Progression Free Survival (PFS)

  Baseline to study completion (up to 24 months)

• Duration of Response (DoR)

  Baseline to study completion (up to 24 months)

• Disease Control Rate (DCR)

  Baseline to study completion (up to 24 months)

• Overall Survival (OS)

  Baseline to study completion (up to 24 months)

Study Arms (1)

MRG003

EXPERIMENTAL

On the first day of every 3 weeks, MRG003 will be administered via intravenous infusion at 2.0 mg/kg calculated based on the actual body weight

Drug: MRG003

Interventions

MRG003 DRUG

Administered intravenously

MRG003

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Shanghai Miracogen Inc.: lead

Study Sites (5)

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

RECRUITING

Henan Tumor Hospital

Zhengzhou, Henan, China

RECRUITING

Hubei Cancer Hospital

Wuhan, Hubei, 430079, China

RECRUITING

Jinan Central Hospital

Jinan, Shandong, 250013, China

RECRUITING

Shandong Cancer Hospital

Jinan, Shandong, 250117, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Aiping Zhou, Doctor

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Program Director

CONTACT

86-21-61637960; clinicaltrials@miracogen.com.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2022
• First Posted: January 12, 2022
• Study Start: May 24, 2021
• Primary Completion: March 21, 2023
• Study Completion: August 1, 2023
• Last Updated: January 12, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (5)