A Study of MRG002 in Patients with HER2-Positive Advanced Solid Tumors and Locally Advanced or Me… (NCT04492488) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
A Study of MRG002 in Patients with HER2-Positive Advanced Solid Tumors and Locally Advanced or Metastatic Gastric/Gastroesophageal Junction (GEJ) Cancer
United States129 participantsStarted 2021-05-24
Plain-language summary
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 can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* The patient must be able to provide written informed consent and follow the requirements specified in protocol.
* Age: ≥18 years.
* Life expectancy ≥6 months.
* 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.
* Available archival tumor tissue (archival or from a new biopsy).
* At least one non-irradiated measurable tumor lesion according to RECIST v1.1.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Acceptable liver, renal, hematologic and coagulation function.
Exclusion Criteria:
* Toxicities (except alopecia \& fatigue) due to prior antitumor therapy are higher than CTCAE v5.0 Grade 1.
* 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.
* Prior palliative or therapeutic radiation therapy to any RECIST v1.1 target lesion that defines baseline measurable disease for the study.
* Untreated or uncontrolled central nervous system (CNS) metastases.
* Any chemotherapy, biotherapy, immunotherapy, radiotherapy or other anti-tumor therapy within 3 weeks of the first dose of study treatment.
* Any severe cardiac dysfunction within 6 months of enrollment.
* Pulmonary embolism or deep vein thrombosis within 3 months prior to the first dose of study drug.
* Concurrent malignancy within 5 years prior to entry.
*…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Maximum Tolerated Dose (MTD)
Timeframe: DLT will be evaluated during the first 21-day treatment cycle (Cycle 1)
2
Recommended Phase II Dose (RP2D)
Timeframe: Day 1 to Day 21 of Cycle 1
3
Objective Response Rate (ORR)
Timeframe: Baseline to study completion (24 months)
4
Incidence of Adverse Events (AEs)
Timeframe: After signing informed consent until 45 days after the last dose of MRG002