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Monoclonal Antibodies
MRG004A for Solid Tumors
Phase 1 & 2
Recruiting
Led By Nashat Y Gabrail, MD
Research Sponsored by Shanghai Miracogen Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Part B: Patients who have documented progression during or relapse following standard therapy, no further treatment options that are known to improve survival, and participation in a clinical trial is a reasonable therapeutic option
A negative serum pregnancy test if female and aged between 18-55 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to study completion (up to 24 months)
Awards & highlights
Study Summary
This trial is testing a new drug, MRG004A, for safety and effectiveness in treating patients with solid tumors that have a protein called tissue factor.
Who is the study for?
This trial is for adults (18+) with advanced or metastatic solid tumors showing Tissue Factor, who've seen their cancer progress after standard treatments. They must have a life expectancy of at least 6 months, measurable disease, good performance status and organ function, and agree to use contraception. Excluded are those with recent serious blood clots, uncontrolled conditions like hypertension or infections, certain treatment histories or severe allergies to MRG004A components.Check my eligibility
What is being tested?
MRG004A is being tested for safety and effectiveness in treating patients whose tumors express Tissue Factor. The study will also look into how the body processes the drug and its potential immune response effects.See study design
What are the potential side effects?
While specific side effects of MRG004A aren't listed here, common ones from similar therapies include infusion reactions, fatigue, allergic responses to drug components, increased risk of infection due to immune system impact and potential bleeding issues.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer has worsened despite treatment and no other standard treatments are likely to help.
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I am a woman aged 18-55 and not pregnant.
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I am 18 years old or older.
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I am fully active or can carry out light work.
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My cancer is advanced, cannot be surgically removed, and has worsened after treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to study completion (up to 24 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to study completion (up to 24 months)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adverse Events (AEs)
Maximum Tolerated Dose (MTD)
Objective Response Rate (ORR)
+1 moreSecondary outcome measures
Disease Control Rate (DCR)
Duration of Response (DoR)
Incidence of anti-drug antibody (ADA)
+5 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: MRG004AExperimental Treatment1 Intervention
All patients in Part A (dose escalation) and Part B (dose expansion) will be administrated MRG004A on Day 1 of every 3 weeks (21-day cycle).
Find a Location
Who is running the clinical trial?
Shanghai Miracogen Inc.Lead Sponsor
20 Previous Clinical Trials
2,297 Total Patients Enrolled
Nashat Y Gabrail, MDPrincipal InvestigatorGabrail Cancer Center Research
1 Previous Clinical Trials
14 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My heart, liver, kidneys, blood, and clotting functions are all within normal ranges.I often have severe difficulty breathing when at rest.You are expected to live for at least 6 more months.I have had episodes of very fast heartbeats or a specific type of heartbeat irregularity.I have severe heart problems.I have not had another cancer in the last 5 years.I haven't taken any corticosteroids in the last 4 weeks.I have no severe allergies to MRG004A or similar medications.I have not had a blood clot in my lungs or legs in the last 3 months.My tumor biopsy shows Tissue Factor presence.I agree to use birth control during and for 6 months after my last treatment.My cancer has worsened despite treatment and no other standard treatments are likely to help.I am a woman aged 18-55 and not pregnant.I do not have any ongoing serious infections.I haven't had any cancer treatments in the last 21 days.I am not on long-term blood thinners or certain other medications, but I can take multivitamins and treatments for bone health.My blood pressure is very high and not well-managed.I am not taking strong drugs that affect liver enzymes with MRG004A.I do not have liver disease, serious infections, HIV/AIDS, uncontrolled autoimmune diseases, or have had an organ transplant.I am 18 years old or older.I have not fully recovered from major surgery in the last 4 weeks or had minor surgery in the last 2 weeks.My side effects from previous radiation are mild or gone.Side effects from my previous cancer treatment are mild, except for hair loss and tiredness.I am fully active or can carry out light work.I am at a high risk of bleeding.You are pregnant or currently breastfeeding.I have brain metastases that are not being treated or are not under control.My cancer is advanced, cannot be surgically removed, and has worsened after treatment.
Research Study Groups:
This trial has the following groups:- Group 1: MRG004A
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there different hospitals trialing this in the city?
"This study has 7 sites, which include Virginia Cancer Specialists in Fairfax, Virginia, Chao Family Comprehensive Cancer Center in Canton, Ohio, and Gabrail Cancer Center Research in Cincinnati, Pennsylvania."
Answered by AI
What is the target number of participants for this clinical trial?
"Yes, the trial is still recruiting patients. Based on the information found on clinicaltrials.gov, this study was first posted on 7/26/2021 and was updated as recently as 9/6/2022. The researchers are hoping to enroll 181 individuals from across 7 sites."
Answered by AI
Are patients being enrolled in this clinical trial at this time?
"That is correct. Presently, this clinical trial is looking for eligible patients. According to the information on clinicaltrials.gov, the study was originally posted on 7/26/2021 and was last edited on 9/6/2022. A total of 181 patients are needed from 7 distinct sites."
Answered by AI
What are the desired outcomes of this research project?
"The primary focus of this 24-month long study is to establish the Maximum Tolerated Dose (MTD) of the medication. Secondary objectives include Overall Survive (OS), Duration of Response (DoR), and Pharmacokinetics (PK) Parameter of MRG004A: Tmax."
Answered by AI
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