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

  • STATUS
    Recruiting
  • participants needed
    152
  • sponsor
    Shanghai Miracogen Inc.
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Updated on 19 February 2024
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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.

Description

This study consists of two parts. In Part A, patients will receive MRG002 as a monotherapy at doses of 2.2, 2.6, or 3.0 mg/kg intravenously (IV) over 60-90 minute on Day 1 of every 3 weeks (Q3W), to determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D). In part B, patients will receive a single IV infusion of MRG002 at RP2D on Day 1 of Q3W.

Details
Condition Advanced Solid Tumors, Advanced or Metastatic Gastric Cancer, Advanced or Metastatic Gastroesophageal Junction Cancer
Age 18years - 100years
Treatment MRG002
Clinical Study IdentifierNCT04492488
SponsorShanghai Miracogen Inc.
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

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
Uncontrolled hypertension (systolic blood pressure >160 mmHg or diastolic blood pressure > 100 mmHg)
History of ventricular tachycardia, or torsade des pointes
History of moderate to severe dyspnea at rest due to advanced malignancies or their complications, severe primary lung disease, current need of continuous oxygen therapy, or clinically active interstitial lung disease (ILD) or pneumonitis
Major surgery within 4 weeks of the first dose of study treatment and not fully recovered. Minor surgery within 2 weeks prior to study treatment
Known allergic reactions to any component or excipient of MRG002 or known allergic reactions to trastuzumab or other prior anti-HER2 or other monoclonal antibody Grade 3\
Patients who have any known liver disease, including chronic hepatitis B, hepatitis C, autoimmune hepatic disorders, primary biliary cirrhosis or sclerosing cholangitis; Patients who have concurrent, serious, uncontrolled infections or known infection with HIV, or have a diagnosed acquired immunodeficiency syndrome (AIDS); or an uncontrolled autoimmune disease, or have undergone organ transplant
Active uncontrolled bacterial, viral, fungal, rickettsial, or parasitic infection
Any severe and/or uncontrolled systemic disease that at the discretion of investigator and sponsor makes it undesirable for the patient to participate in this study
Use of systemic corticosteroids within 4 weeks prior to the first dose of treatment
Use of strong CYP3A4 inhibitors
Pregnancy or breast-feeding
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