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UNKNOWNPHASE2

A Study of MRG002 in the Treatment of HER2-positive/HER2-low Locally Advanced or Metastatic Gastric/Gastroesophageal Junction Cancer.

An Open-label, Multi-center, Phase II Clinical Study to Evaluate the Safety, Efficacy and Pharmacokinetics of MRG002 in Patients With HER2-positive/HER2-low Locally Advanced or Metastatic Gastric/ Gastroesophageal Junction Cancer.

NCT05141747•Shanghai Miracogen Inc.

View on ClinicalTrials.gov

Summary

The objective of this study is to assess the safety, efficacy, pharmacokinetics, and immunogenicity of MRG002 as single agent in patients with HER2-positive /HER2-low locally advanced or metastatic gastric/ gastroesophageal junction cancer.

Detailed Description

There are two cohorts in this study. HER2-positive and HER2-low patients will be allocated to cohort 1 and cohort 2, respectively. When the 20th, 40th, or 60th patient in each cohort completed at least one post-baseline tumor assessment, the Safety Monitoring Committee will review the safety and efficacy of these patients to determine dose selection, enrollment continuation, study population, and sample size.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Willing to sign the ICF and follow the requirements specified in the protocol.
•2. Aged ≥18.
•3. Life expectancy ≥ 3 months.
•4. Patients with histologically or cytologically confirmed gastric/ gastroesophageal junction cancer.
•5. In Cohort 1, a positive HER2 test result defined as follows: IHC 3+ or IHC 2+ and ISH positive. In Cohort 2, low HER2 expression defined as follows: IHC 1+, or IHC 2+ and ISH negative.
•6. Documented tumor progression or intolerance during or after at least one prior line of platinum- and/or fluoropyrimidine-based chemotherapy ± anti-HER2 (trastuzumab or equivalent) therapy.
•7. Willing and able to provide adequate archival tumor tissue samples for HER2 status confirmation by central laboratory.
•8. Cohort 1 patients, who have received prior anti-HER2 therapy, are willing to undergo fresh tissue biopsy to confirm HER2 status as assessed by the investigator to be feasible and safe.
•9. Patients must have at least one measurable tumor lesion according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
•10. The score of ECOG for performance status is 0 or 1 with no deterioration within 2 weeks prior to the first dose of the study drug.
+1 more criteria

Exclusion Criteria

•1. Patients with the following pathological diagnosis: squamous cell carcinoma, carcinoid tumor, neuroendocrine carcinoma, undifferentiated carcinoma, or other unclassifiable gastric cancer.
•2. Peripheral neuropathy ≥ Grade 2 per CTCAE 5.0.
•3. Prior treatment with HER2-targeted ADC.
•4. Known allergic reaction to any component or excipient of MRG002, or known allergic reaction to trastuzumab or other prior anti-HER2 or other monoclonal antibodies ≥ Grade 3.
•5. Presence of untreated or uncontrolled central nervous system (CNS) metastases.
•6. Patients received chemotherapy, biological therapy, radical radiotherapy or other anti-tumor treatment within 3 weeks prior to the first dose of the study drug.
•7. Any severe cardiac dysfunction, history of myocardial infarction, stroke, or transient ischemic attack (TIA) within 6 months prior to enrollment.
•8. Pulmonary embolism or deep venous thrombosis within 3 months prior to the first dose of the study drug.
•9. Tumor lesions with bleeding tendency or treated with blood transfusion within 2 weeks prior to the first dose of the study drug.
•10. Toxicities due to prior anti-cancer therapy have not resolved to ≤ Grade 1 (CTCAE v5.0).
+12 more criteria

Locations (3)

Cancer Hospital Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, Beijing Municipality, China

Hunan Cancer Hospital

Changsha, Hunan, China

Shanghai Oriental Hospital

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

January 19, 2022

Primary Completion Date

December 1, 2023

Completion Date

December 1, 2023

Last Updated

February 23, 2022

Enrollment

ESTIMATED participants

Conditions

Locally Advanced Gastric CancerMetastatic HER2 Positive Gastroesophageal Junction Cancer

Interventions

MRG002

DRUG

Contacts

Program Director

CONTACT

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

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 23, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of MRG002 in the Treatment of HER2-positive/HER2-low Locally Advanced or Metastatic Gastric/Gastroesophageal Junction Cancer.

Inclusion Criteria

Exclusion Criteria

Machine Learning-driven Noninvasive Screening of Transcriptomics Liquid Biopsies for Early Diagnosis of Occult Peritoneal Metastases in Locally Advanced Gastric Cancer

TAC T-cells for the Treatment of HER2-positive Solid Tumors

Comparison of Short Term Outcomes Between Totally Laparoscopic and Laparoscopy-Assisted Distal Gastrectomy With Billroth-II Reconstruction and D2 Lymphadenectomy for Locally Advanced Gastric Cancer