405 Participants Needed

MRG007 for Cancer

Recruiting at 14 trial locations
PD
Overseen ByProgram Director
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called MRG007 for individuals with advanced solid tumors that cannot be surgically removed and have not responded to other treatments. The trial aims to determine the safety and effectiveness of MRG007. Participants must have a confirmed solid tumor unresponsive to standard treatments and be willing to undergo testing for a specific marker (CDH17) related to their tumor. This trial offers an opportunity for those who have exhausted standard treatment options to explore a new potential therapy. As a Phase 1 trial, the research focuses on understanding how MRG007 works in people, giving participants the chance to be among the first to receive this new treatment.

Do I need to stop my current medications to join the trial?

The trial requires that you stop taking certain medications, such as other investigational drugs, systemic corticosteroids, and potent CYP3A4 inducers or inhibitors, at least 2 weeks before starting the trial. It's best to discuss your current medications with the trial team to see if any need to be paused.

Is there any evidence suggesting that MRG007 is likely to be safe for humans?

Research shows that MRG007 remains in the early testing stages, so detailed safety information is limited. However, its testing in humans suggests that earlier lab and animal studies were promising enough to proceed. In the early phases of clinical trials, researchers focus on safety and how well participants tolerate the treatment. They monitor for any unwanted effects and adjust doses to ensure participant safety. Although specific safety data for MRG007 is not yet available, the trial's phase indicates close monitoring of participant safety.

Why do researchers think this study treatment might be promising?

Researchers are excited about MRG007 because it offers a novel approach to cancer treatment. Unlike many existing therapies that target cancer cells broadly, MRG007 is designed to specifically target and bind to certain proteins found on the surface of cancer cells, potentially leading to more precise treatment with fewer side effects. This specificity could mean a more effective attack on the cancer cells while sparing healthy tissue, which is a significant improvement over traditional chemotherapy. Additionally, MRG007 may be delivered in a way that enhances its ability to penetrate tumors, offering hope for improved outcomes in cancer care.

What evidence suggests that MRG007 might be an effective treatment for cancer?

Research has shown that MRG007, the treatment under study in this trial, targets specific proteins present in many solid tumors. This treatment attaches to cancer cells and delivers a toxic substance to destroy them. Early lab and animal studies showed promise, with significant tumor shrinkage observed. Although human data remains limited, these initial results suggest MRG007 could effectively attack cancer cells in difficult-to-treat tumors. More studies are needed to confirm these effects in humans, but this targeted approach offers hope for its effectiveness.

Who Is on the Research Team?

LS

Lin Shen, M.D.

Principal Investigator

Peking University Cancer Hospital & Institute

Are You a Good Fit for This Trial?

This trial is for patients with advanced solid tumors like colorectal, stomach, or pancreatic cancer who have not responded to standard treatments or can't tolerate them. They must be willing to consent, have a life expectancy of at least 3 months, provide a tumor sample for testing, and have at least one measurable lesion. Participants should be relatively active (ECOG score 0-1) and meet certain organ function criteria.

Inclusion Criteria

I am willing to sign the consent form and follow the study rules.
My doctor expects me to live for at least 3 more months.
I can provide a tumor sample for CDH17 testing or agree to a biopsy.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive MRG007 (ARR-217) to evaluate safety, tolerability, efficacy, and pharmacokinetics

24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • MRG007

Trial Overview

The study is testing MRG007 (ARR-217), focusing on its safety, tolerability, effectiveness, and how the body processes it. It's an early-phase trial involving people with serious cancers that are locally advanced or spread elsewhere and cannot be surgically removed.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: MRG007Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Lepu Biopharma Co., Ltd.

Lead Sponsor

Shanghai Miracogen Inc.

Lead Sponsor

Trials
21
Recruited
2,500+

ArriVent BioPharma, Inc.

Industry Sponsor

Trials
2
Recruited
550+