MRG002 for Gastric Cancer

Recruiting at 1 trial location

Overseen By Rakesh H Nandan, MBBS, MPH

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Shanghai Miracogen Inc.

Must not be taking: Corticosteroids, CYP3A4 inhibitors

Disqualifiers: CNS metastases, Cardiac dysfunction, Hypertension, others

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

Compensation: Varies

Number of Visits: 2

129 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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 anti-drug antibody (ADA) of MRG002 in patients with HER2-positive advanced solid tumors and locally advanced or metastatic gastric/gastroesophageal junction (GEJ) cancer.

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

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

The patient must be able to provide written informed consent and follow the requirements specified in protocol

Must have histologically or cytologically confirmed HER2-positive metastatic, unresectable cancer and must have had prior disease progression on all standard therapies for their tumor

Exclusion Criteria

Toxicities due to radiotherapy (higher than grade 1) have not resolved to CTCAE v5.0 Grade ≤1 at least 21 days prior to the screening visit

Toxicities (except alopecia & fatigue) due to prior antitumor therapy are higher than CTCAE v5.0 Grade 1

Prior palliative or therapeutic radiation therapy to any RECIST v1.1 target lesion that defines baseline measurable disease for the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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)

21 days per cycle

1 visit every 3 weeks

Dose Expansion

Patients receive a single IV infusion of MRG002 at RP2D on Day 1 of every 3 weeks

21 days per cycle

1 visit every 3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

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?

Group I: Solid Tumors Experimental Treatment 1 Intervention

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).

Group II: Locally Advanced or Metastatic Gastric/GEJ Cancer Experimental Treatment 1 Intervention

MRG002 will be administrated by an IV infusion 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+