About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Subjects who voluntarily signed a written informed consent form before the start of the study;
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 .
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;
At least 4 weeks or 5 half-lives (whichever is shorter) have elapsed since the most recent treatment (chemotherapy, targeted therapy, immunotherapy, radiotherapy, and/or major surgery, etc.), and the participant has recovered from toxicities caused by prior treatment to grade ≤ 1 (Common Terminology Criteria for Adverse Events [CTCAE] v6.0) [except for alopecia, pigmentation, peripheral sensory neuropathy, hypothyroidism, and other toxicities judged by the investigator to pose no safety risk];
Disqualifiers
Women during pregnancy or breastfeeding;
Positive syphilis testing; positive hepatitis C virus (HCV) antibody with HCV-RNA > ULN;;
Have received investigational drug treatment in other clinical oncology therapeutic trials within 4 weeks prior to enrollment;
Aallergy to the active ingredient or excipients of the investigational medicinal product;
Trial design
Single group
Treatments tested in this trial
Hemay5087
Drugintravenous infusion,once every 3 weeks
Treatment groups
Trial outcomes
Primary outcomes
Number of participants with adverse events
Incidence of dose-limiting toxicity (DLT) in each dose group
Maximum tolerated dose (MTD) or Maximum climbing dose (MAD) of Hemay181
Subsequent recommended doses of Hemay181
Secondary outcomes
Objective Response Rate
Duration of Response
Disease Control Rate
Time to Response
Locations
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: