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Monoclonal Antibodies

MRG002 for Gastric Cancer

Phase 1 & 2

Waitlist Available

Led By Crystal Denlinger, 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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to study completion (24 months)

Awards & highlights

Study Summary

This trial is testing a new drug, MRG002, to see if it is safe and effective in treating patients with HER2-positive cancer. The trial will also look at how the body processes the drug and if it causes any immunity problems.

Eligible Conditions

Gastric Cancer
Gastroesophageal Junction Cancer
Solid Tumors

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to study completion (24 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to study completion (24 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to study completion (24 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of Adverse Events (AEs)

Maximum Tolerated Dose (MTD)

Objective Response Rate (ORR)

+1 more

Secondary outcome measures

Disease Control Rate (DCR)

Duration of Response (DoR)

Immunogenicity

+7 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Solid TumorsExperimental Treatment1 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 CancerExperimental Treatment1 Intervention

MRG002 will be administrated by an IV infusion on Day 1 of every 3 weeks (21-day cycle).

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Shanghai Miracogen Inc.Lead Sponsor

20 Previous Clinical Trials

2,349 Total Patients Enrolled

Crystal Denlinger, MDPrincipal InvestigatorFox Chase Cancer Center

2 Previous Clinical Trials

1,484 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment for this trial open to prospective participants?

"As confirmed by clinicaltrials.gov, this experiment is presently in search of volunteers. The research study was initially advertised on May 24th 2021 and the data has been most recently updated as of May 4th 2022."

Answered by AI

What is the ultimate objective of this medical experiment?

"Shanghai Miracogen Inc., the sponsor of this study, has determined that Recommended Phase II Dose (RP2D) will be the primary outcome evaluated during a DLT over 21 days. Secondary outcomes such as Cmax and AUClast for Monomethyl Auristatin E (MMAE), both derived from PK blood samples, will also be monitored with descriptive statistics."

Answered by AI

What is the current enrollment count for this clinical research?

"Yes, the information listed on clinicaltrials.gov corroborates that individuals are actively sought out for this medical experiment. The trial was originally declared open to enrolment back in May of 2021 and recently updated in May 2022. Two sites need 129 participants combined to complete the study's requirements."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of MRG002 in Patients With HER2-Positive Advanced Solid Tumors and Locally Advanced or Metastatic Gastric/Gastroesophageal Junction (GEJ) Cancer

2021. "A Study of MRG002 in Patients With HER2-Positive Advanced Solid Tumors and Locally Advanced or Metastatic Gastric/Gastroesophageal Junction (GEJ) Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04492488.