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NCT07624864
A Study to Evaluate the Safety, Tolerability, PK and Efficacy of Hemay5087 in Patients With Advanced Solid Tumors
Conditions: Solid Tumors
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: PHASE1
Enrollment: 24
Sponsor: Ganzhou Hemay Pharmaceutical Co., Ltd
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.
Eligibility Criteria
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 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) \[except for alopecia, pigmentation, peripheral sensory neuropathy, hypothyroidism, and other toxicities judged by the investigator to pose no safety risk\];
5. Subjects with ECOG PS score of 0-1;
6. Subjects with expected survival more than 3 months;
7. Participants (including their partners) have no plan for pregnancy from signing the informed consent form through 6 months after the last dose and voluntarily agree to use effective contraception;
Exclusion Criteria:
1. Women during pregnancy or breastfeeding;
2. Positive syphilis testing; positive hepatitis C virus (HCV) antibody with HCV-RNA \> ULN;;
3. Have received investigational drug treatment in other clinical oncology therapeutic trials within 4 weeks prior to enrollment;
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.
Source: ClinicalTrials.gov (NCT07624864). StuddyBuddy aggregates publicly available trial information.
