MRG002 for Gastric Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a treatment called MRG002 for individuals with HER2-positive gastric or gastroesophageal junction cancer. The researchers aim to assess the treatment's safety, effectiveness, and the body's response. Participants will receive MRG002 through an IV infusion every three weeks. This trial may suit those diagnosed with HER2-positive cancer that has spread or cannot be removed and who have exhausted all standard treatments without success. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive it.
Do I need to stop my current medications to join the trial?
The trial requires that you stop any chemotherapy, biotherapy, immunotherapy, radiotherapy, or other anti-tumor therapy at least 3 weeks before starting the study treatment. You also need to stop using systemic corticosteroids 4 weeks before the first dose. The protocol does not specify other medications, but it's best to discuss your current medications with the trial team.
Is there any evidence suggesting that MRG002 is likely to be safe for humans?
Research has shown that MRG002 has promising safety results. In early tests, MRG002 was generally well-tolerated and did not cause serious side effects. These tests used models that imitate human cancers, such as breast and stomach cancer.
Although specific results from human trials are not yet available, the testing of MRG002 in people suggests it has passed initial safety checks. This treatment targets HER2, a protein that can help cancer cells grow. By focusing on HER2, MRG002 aims to attack cancer cells while sparing normal cells, potentially reducing side effects.
In summary, early studies suggest MRG002 is well-tolerated, with no major safety concerns reported so far. This is encouraging for those considering participation in a clinical trial for this treatment.12345Why do researchers think this study treatment might be promising?
MRG002 is unique because it targets gastric cancer cells with precision. Unlike standard chemotherapy, which attacks all rapidly dividing cells and can lead to significant side effects, MRG002 uses an antibody-drug conjugate to deliver its cancer-fighting agent directly to tumor cells, sparing healthy ones. This targeted approach not only promises to be more effective but also potentially reduces the side effects typically seen with traditional treatments. Researchers are excited about MRG002 because it offers a new way to combat gastric cancer by homing in on the cancer cells themselves, which could lead to better outcomes and improved quality of life for patients.
What evidence suggests that MRG002 might be an effective treatment for gastric cancer?
Research has shown that MRG002 could help treat HER2-positive stomach cancer. In this trial, participants will receive MRG002, an antibody-drug conjugate (ADC) designed to deliver chemotherapy directly to cancer cells. This targeted method may enhance treatment effectiveness and improve patient outcomes. Studies have found that ADCs can sometimes outperform traditional treatments. MRG002 aims to leverage this potential for better results in advanced stomach cancer.16789
Who Is on the Research Team?
Crystal Denlinger, MD
Principal Investigator
Fox Chase Cancer Center
Are You a Good Fit for This Trial?
This trial is for adults over 18 with HER2-positive advanced solid tumors or gastric/GEJ cancer that's spread and didn't respond to standard treatments. They must have a life expectancy of at least 6 months, a good performance status, and proper organ function. Excluded are those with unresolved radiation side effects, severe heart issues, uncontrolled blood pressure, recent major surgery or other therapies, active infections or certain medical conditions.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Patients receive MRG002 as a monotherapy at doses of 2.2 or 2.6 mg/kg intravenously to determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D)
Dose Expansion
Patients receive a single IV infusion of MRG002 at RP2D on Day 1 of every 3 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- MRG002
Trial Overview
The study tests MRG002's safety and effectiveness in treating HER2-positive cancers. It also looks at how the body processes the drug and its potential to cause immune reactions (like producing antibodies against it). Patients will receive MRG002 and be monitored for tumor response and any changes in their health.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Phase I Dose Escalation: MRG002 will be administrated by an IV infusion of escalating doses (starting dose of 2.2 mg/kg, followed by 2.6 mg/kg) on Day 1 of every 3 weeks (21-day cycle).
MRG002 will be administrated by an IV infusion on Day 1 of every 3 weeks (21-day cycle).
Find a Clinic Near You
Who Is Running the Clinical Trial?
Shanghai Miracogen Inc.
Lead Sponsor
Citations
NCT04492488 | A Study of MRG002 in Patients with HER2 ...
The objective of this study is to assess the safety, efficacy, and pharmacokinetics of MRG002, as well as the immunogenicity as defined by the incidence of ...
Navigating the future of gastric cancer treatment: a review on ...
ADCs have generated significant interest in clinical trials as a promising approach to improve both treatment efficacy and patient outcomes in gastric cancer.
MRG002 for Gastric Cancer · Info for Participants
Trial Overview The study tests MRG002's safety and effectiveness in treating HER2-positive cancers. It also looks at how the body processes the drug and its ...
Research progress of antibody-drug conjugates therapy for ...
Only 13.3% of patients experienced grade 3 adverse events related to ARX788, and no grade 4 or 5 adverse events occurred. The study showed that ARX788 was well ...
HER2-low gastric cancer: is the subgroup targetable?
Trastuzumab deruxtecan showed excellent antitumor activity in mouse xenografts with low HER2 expression and was more effective than another ADC ...
HER2-targeted advanced metastatic gastric/gastroesophageal ...
This paper reviews HER2-targeted drugs for advanced metastatic G/GEJ adenocarcinoma, potential resistance mechanisms and future directions.
Preclinical evaluation of MRG002, a novel HER2-targeting ...
MRG002 has demonstrated a favorable toxicity profile and potent antitumor activities in the breast and gastric PDX models with varying levels of HER2 ...
A Study of MRG002 in Patients with HER2-Positive ...
The objective of this study is to assess the safety, efficacy, and pharmacokinetics of MRG002, as well as the immunogenicity as defined by the incidence of ...
A real-world study on epidemiology, biomarker test results ...
The aim of this observational, descriptive study was to understand the epidemiology, biomarker test results, clinical characteristics, and treatment patterns
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