MRG004A for Solid Tumors

Not currently recruiting at 9 trial locations

Overseen By Jenny Li

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Shanghai Miracogen Inc.

Must not be taking: CYP3A4 inhibitors, Anti-coagulatives

Disqualifiers: CNS metastases, Cardiac dysfunction, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called MRG004A for individuals with advanced or metastatic solid tumors, which are cancers that have spread and cannot be surgically removed. The research aims to determine the safety and effectiveness of MRG004A, how the body processes it, and whether it triggers an immune response. Suitable candidates have solid tumors that have worsened despite treatment and show Tissue Factor presence in their tumors. Participants should have experienced disease progression after standard therapies and may have no other treatment options available. 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 this new therapy.

Will I have to stop taking my current medications?

The trial requires stopping any anti-cancer therapy within 21 days before starting the study treatment and prohibits its use during the study. You also cannot use systemic corticosteroids within 4 weeks before the first dose or strong CYP3A4 inhibitors or inducers with MRG004A. However, multivitamins, calcium, vitamin D, and certain bone metastases therapies are allowed.

Is there any evidence suggesting that MRG004A is likely to be safe for humans?

Studies have shown that MRG004A has side effects that can usually be managed without serious problems. Research indicates that this treatment has been tested on patients who tried other treatments without success, yet it still showed promise in fighting tumors. Evidence suggests that while some side effects exist, they are generally not severe and can be managed with medical care. This makes MRG004A a potentially safe option for further investigation in treating solid tumors. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for solid tumors, which often include chemotherapy and radiation, MRG004A is unique because it specifically targets cancer cells with a novel mechanism of action. This investigational drug is an antibody-drug conjugate (ADC), which means it combines an antibody with a cytotoxic drug to directly attack tumor cells while sparing healthy tissue. Researchers are excited about MRG004A because it has the potential to reduce side effects compared to traditional therapies and enhance the precision of cancer treatment. This targeted approach could lead to better outcomes and improved quality of life for patients.

What evidence suggests that MRG004A might be an effective treatment for solid tumors?

Research has shown that MRG004A yields promising results in treating solid tumors with high levels of Tissue Factor (TF). In earlier studies, this treatment effectively reduced tumor size in patients who had tried many other treatments. Specifically, among patients with triple-negative breast cancer (TNBC), 25% saw their tumors shrink, and half experienced disease stabilization. The side effects were manageable, suggesting it as a potential option for those with advanced cancer. Overall, MRG004A demonstrates strong antitumor activity, offering hope for those facing difficult-to-treat cancers. ^{1 2 3 4 5}

Who Is on the Research Team?

Nashat Gabrail, M.D.

Principal Investigator

Gabrail Cancer Center Research

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My heart, liver, kidneys, blood, and clotting functions are all within normal ranges.

You are expected to live for at least 6 more months.

Understands and provides written informed consent and willing to follow the requirements specified in protocol

Exclusion Criteria

I often have severe difficulty breathing when at rest.

I have had episodes of very fast heartbeats or a specific type of heartbeat irregularity.

I have severe heart problems.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Part A: Dose escalation study to determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of MRG004A

21-day cycles, up to 24 months

Visits every 3 weeks

Dose Expansion

Part B: Disease specific multi-cohort dose expansion study to further assess the efficacy and safety of MRG004A at confirmed RP2D

21-day cycles, up to 24 months

Visits every 3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

30-45 days after the last dose

What Are the Treatments Tested in This Trial?

Interventions

• MRG004A

Trial Overview 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.

How Is the Trial Designed?

Group I: MRG004A Experimental Treatment 1 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).

Who Is Running the Clinical Trial?

Shanghai Miracogen Inc.

Lead Sponsor

Trials

21

Recruited

2,500+

Citations

1. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.3002

Phase I/II first-in-human study to evaluate the safety and ... MRG004A demonstrated a manageable toxicity and a striking antitumor activity across multiple tumor types with high TF expression in heavily pretreated setting.

2. targetedonc.com targetedonc.com/view/novel-antibody-drug-conjugate-shows-potential-in-solid-tumor-treatment

Novel Antibody-Drug Conjugate Shows Potential in Solid ... MRG004A also demonstrated efficacy in other cancer types. Among 4 patients with heavily treated TNBC, the ORR was 25%, and the DCR was 50%. Of 2 ...

3. ascopubs.org ascopubs.org/doi/pdf/10.1200/JCO.2024.42.16_suppl.3002

ADC MRG004A in patients with solid tumors. Herein, we present the pre- liminary safety and efficacy data from phase I/II MRG004A-001. Methods: This is an interim report (Data cutoff: Dec 15, 2023) of ...

4. mycancergenome.org mycancergenome.org/content/clinical_trials/NCT04843709/

Clinical Trial: NCT04843709 The objective of this study is to evaluate the safety, efficacy, pharmacokinetics, and immunogenicity of MRG004A in patients with Tissue Factor ...

5. clinicaltrial.be clinicaltrial.be/fr/details/45171?only_active=0&only_eligible=0&only_recruiting=0&per_page=100

A Study of MRG004A in Patients With Tissue Factor Positiv... The dose level of MRG004A recommended for further clinical studies based on assessment of the safety, efficacy and PK data from Part A of this ...