An open-label phase I clinical study,which enrolled subjects with advanced solid tumors who have failed to respond to adequate standard therapies or have no available effective standard therapy.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
1. Subjects who voluntarily signed a written informed consent form before the start of the study;
2. Subjects who have pathologically (histologically or cytologically) confirmed advanced solid tumorsand have failed to respond to adequate standard therapies or currently have no available effective standard therapy .
3. Subjects who have a least one measurable lesion that can be evaluated by CT/MRI and meets the requirement for reproducible evaluation in RECIST V1.1;
4. At least 4 weeks or 5 half-lives (whichever is longer) following the most recent treatment (chemotherapy, targeted therapy, immunotherapy, radiotherapy, and/or major surgery), with recovery from treatment-induced adverse reactions to ≤ Grade 1 (CTCAE Version 5.0) \[Patients with alopecia (any grade), hyperpigmentation (any grade), or peripheral sensory neuropathy (≤ Grade 2) may be included\].
5. Subjects with ECOG PS score of 0-1;
6. Subjects with expected survival more than 3 months;
7. Women of childbearing potential (including partners) who are not planning to become pregnant and who voluntarily take effective contraceptive measures from signing the informed consent form until 6 months after the last dose in the study;
Exclusion Criteria:
1. Women during pregnancy or breastfeeding;
2. HIV test positive; syphilis test positive; hepatitis B surface antigen positive with HBV-DNA exceeding the upper limit of normal; hepatitis C virus (HCV) antibody positive with HCV-RNA exceeding the upper limit of normal;
3. Having received drug treatment from another clinical trial within the four weeks prior to enrolment;
4. Aallergy to the active ingredient or excipients of the investigational medicinal product;
5. Patients with a history of alcohol or drug abuse or dependence, or a history of severe mental illness;
6. The investigator considers the subject to be unsuitable for participation in this clinical trial due to any clinical or laboratory abnormalities.
Primary outcome measure(s)
Efficacy indicators — From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months Objective response rate (ORR)
Trial sites (1)
Facility
City
Region
Status
Xinxiang Medical University First Affiliated Hospital
Xinxiang
Henan
Recruiting
More Ganzhou Hemay Pharmaceutical Co., Ltd trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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