A Study of M802 (HER2 and CD3) in HER2-Positive Advanced Solid Tumors (NCT04501770) | Clinical Trial Compass
CompletedPhase 1
A Study of M802 (HER2 and CD3) in HER2-Positive Advanced Solid Tumors
China34 participantsStarted 2018-09-27
Plain-language summary
The purpose of this study is to evaluate the safety and tolerability of different doses of M802 in patients with HER2-positive advanced solid tumors, and to determine the dose limiting toxicity (DLT) and the maximum tolerated dose (MTD) so as to provide basis for the recommended phase 2 dose (RP2D).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Males or females, aged ≥18 years old.
✓. Patients must have a diagnosis of histologically or cytologically confirmed metastatic advanced solid tumor with failure to standard treatment and who have no available therapy that may confer clinical benefit. Patients with HER2-positive metastatic breast cancer should have received standard anti-HER2 therapies.
✓. HER2 expression status report should be provided during the screening period with fluorescence in-situ hybridization (FISH) or Chromogenic in situ hybridization (CISH) test positive, or immunohistochemistry IHC 3+, or immunohistochemistry IHC 2+ and confirmed by amplification of FISH or CISH.
✓. Patients must have stopped anti-tumor treatment for at least 4 weeks prior to the first dose of M802. The anti-tumor treatment includes chemotherapy, immunotherapy, targeted therapy, endocrine therapy, and radiotherapy (except for local radiation therapy for alleviating pain, at least 14 days after end of treatment).
✓. Patients must have measurable lesions at baseline according to the RECIST Version 1.1.
✓. Patients must have an ECOG performance status (PS) Score of 0-1.
✓. Patients must have an expected survival \> 12 weeks.
✓. Patients must have a baseline left ventricular ejection fraction (LVEF) ≥ 50%.
Exclusion criteria
✕. Patients who had prior treatment with trastuzumab or similar monoclonal drugs within 4 weeks before first dosing of M802.
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What they're measuring
1
MTD
Timeframe: From the time of first dosing (Day 1) until the forth dosing (Day 28)
2
RP2D
Timeframe: From the start of administration to the end of the study or 28 days after the administration is stopped (up to 1 years and 28 days)
✕. Patients who have uncontrollable active infections (Grade ≥ 2 according to CTCAE Version 5.0).
✕. Patients with severe respiratory disease who are not suitable for the study at the judgment of investigator.
✕. Patients with severe immunosuppression (long-term use of immunosuppressant or glucocorticoid with daily dosage of dexamethasone ≥10 mg).
✕. Patients who have other malignant tumors in the past 5 years, except the complete cured cervical carcinoma in situ or basal cell or squamous cell carcinoma.
✕. Patients with a history of serious cardiovascular disease, including receiving coronary artery bypass grafts or coronary stenting, occurrence of myocardial infarction, congestive heart failure within 6 months, or a history of unstable angina, uncontrolled severe hypertension or arrhythmia requiring medication.
✕. Patients with a history of autoimmune diseases (e.g. inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, hemolytic anemia, scleroderma, severe psoriasis, rheumatoid arthritis).