Advanced Solid Tumors
Conditions
Brief summary
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.
Interventions
DRUGHemay181
intravenous infusion，once every 3 weeks
Sponsors
Ganzhou Hemay Pharmaceutical Co., Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety 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 | Occurrence of adverse events (AEs) and serious adverse events (SAEs) |
Countries
China
Contacts
CONTACTXu, Doctor
Outcome results
None listed