MRG002 for Gastric Cancer

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen ByCrystal Denlinger, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Shanghai Miracogen Inc.

No Placebo Group

Trial Summary

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.

Eligibility Criteria

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.

Participant Groups

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.

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).