Phase
Condition
Neuroblastoma
Neoplasms
Treatment
SPH 3348
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patients with advanced solid tumors with c-Met abnormalities who have failedstandard of care or are not eligible for standard therapy currently
ECOG score of 0 or 1.
Patients must have measurable lesion that can be assessed by imaging per RECIST 1.1criteria.
Expected survival > 12 weeks.
Patients must have adequate organ function
Patients must give informed consent to the study and sign the informed consent formprior to the trial.
Exclusion
Exclusion Criteria:
Received anti-tumor therapies, including but not limited to chemotherapy,biotherapy, radiotherapy, targeted therapy, etc., within 4 weeks prior to the firstdose of study drug; received nitrosoureas or mitomycin C within 6 weeks prior to thestart of study drug.
Received small molecule tyrosine kinase inhibitors within 2 weeks prior to the firstdose.
Received strong CYP3A4 inducers or inhibitors or CYP3A4 substrates with narrowtherapeutic windows within 2 weeks prior to the start of study drug.
Patients with active hepatitis B (hepatitis B surface antigen (HBsAg) positive) orhepatitis C (HCV).
Toxicities caused by prior treatments have not recovered to CTCAE Grade ≤ 1 orhaving ≥Grade 2 peripheral neuropathy, except for alopecia and other events judgedas tolerable by the investigator.
Known allergy to any component of the reference drug.
Known drug or alcohol dependence.
Received surgical treatment including surgical and interventional procedures within 4 weeks prior to the start of study drug.
Patients with brain metastases.
Past medical history of interstitial lung disease, drug-induced interstitial lungdisease, radiation pneumonitis which required steroid treatment, or evidence of anyclinically active interstitial lung disease.
Acute bacterial, viral, or fungal infection requiring systemic therapy orunexplained fever (temperature > 38.5 °C) during screening, prior to the first dose.
Neurological and psychiatric patients with obvious poor compliance.
Any of the following within 6 months prior to signing of informed consent form:uncontrolled congestive cardiac failure, severe or unstable angina pectoris,myocardial infarction, stroke, coronary/peripheral artery bypass surgery, pulmonaryembolism.
Arrhythmia uncontrolled by medication or sustained QTcB prolongation.
Hypertension uncontrolled by medication
Participated in other drug clinical studies within 28 days prior to the first doseof study drug.
Women who are pregnant or in lactation period or women/men with childbearing plans.
Patients who cannot take oral medication, or have previous surgical history orserious gastrointestinal diseases such as dysphagia, active gastric ulcer, which mayimpair the absorption of the study drug in the investigator's opinion.
Other prior or current concomitant malignancies.
Patients who are ineligible to participate in this trial for any reason judged bythe investigator.
Study Design
Connect with a study center
The First Affliated Hospital of Bengbu Medical College
Bengbu, Anhui 233004
ChinaSite Not Available
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.