MRG004A for Solid Tumors

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

181 Participants Needed

Trial Summary

What is the purpose of this trial?

The objective of this study is to evaluate the safety, efficacy, pharmacokinetics, and immunogenicity of MRG004A in patients with Tissue Factor positive advanced or metastatic solid tumors.

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.

Research Team

Nashat Gabrail, M.D.

Principal Investigator

Gabrail Cancer Center Research

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+