Not yet recruiting NCT07624864
A Study to Evaluate the Safety, Tolerability, PK and Efficacy of Hemay5087 in Patients With Advanced Solid Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Hemay5087.
- Who it may be relevant to
- Registry conditions: Solid Tumors. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A PHASE I CLINICAL STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETIC CHARACTERISTICS, AND PRELIMINARY ANTI-TUMOR EFFICACY OF HEMAY5087 IN PATIENTS WITH ADVANCED SOLID TUMORS
Overview
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
- Drug Hemay5087
intravenous infusion，once every 3 weeks
Primary outcome measures
- Number of participants with adverse events [Time frame: 3 weeks of treatment]
- Incidence of dose-limiting toxicity (DLT) in each dose group [Time frame: 3 weeks of treatment]
- Maximum tolerated dose (MTD) or Maximum climbing dose (MAD) of Hemay181 [Time frame: 3 weeks of treatment]
- Subsequent recommended doses of Hemay181 [Time frame: 3 weeks of treatment]
Secondary outcome measures (12)
- Objective Response Rate [Time frame: 3 weeks of treatment]
- Duration of Response [Time frame: 3 weeks of treatment]
- Disease Control Rate [Time frame: 3 weeks of treatment]
- Time to Response [Time frame: 3 weeks of treatment]
- Progression-Free Survival [Time frame: 3 weeks of treatment]
- Maximum Plasma Concentration （Cmax） [Time frame: 0，0.75, 1.5, 1.75, 2, 2.5, 5.5, 9.5, 25.5, 49.5,121.5, 217.5, 313.5,481.5 hours post-dose on day 1, and 0，1.5, 2.5 hours post-dose on day 22]
- Time to reach maximum concentration （Tmax） [Time frame: 0，0.75, 1.5, 1.75, 2, 2.5, 5.5, 9.5, 25.5, 49.5,121.5, 217.5, 313.5,481.5 hours post-dose on day 1, and 0，1.5, 2.5 hours post-dose on day 22]
- Elimination half life(t1/2) [Time frame: 0，0.75, 1.5, 1.75, 2, 2.5, 5.5, 9.5, 25.5, 49.5,121.5, 217.5, 313.5,481.5 hours post-dose on day 1, and 0，1.5, 2.5 hours post-dose on day 22]
- Plasma Clearance（CL) [Time frame: 0，0.75, 1.5, 1.75, 2, 2.5, 5.5, 9.5, 25.5, 49.5,121.5, 217.5, 313.5,481.5 hours post-dose on day 1, and 0，1.5, 2.5 hours post-dose on day 22]
- Mean Residence Time from 0 to last time of quantifiable concentration(MRT 0-t) [Time frame: 0，0.75, 1.5, 1.75, 2, 2.5, 5.5, 9.5, 25.5, 49.5,121.5, 217.5, 313.5,481.5 hours post-dose on day 1, and 0，1.5, 2.5 hours post-dose on day 22]
- Mean Residence Time from 0 to infinite time(MRT 0-∞) [Time frame: 0，0.75, 1.5, 1.75, 2, 2.5, 5.5, 9.5, 25.5, 49.5,121.5, 217.5, 313.5,481.5 hours post-dose on day 1, and 0，1.5, 2.5 hours post-dose on day 22]
- Area under the plasma concentration-time curve from 0 to last time of quantifiable concentration(AUC 0-t) [Time frame: 0，0.75, 1.5, 1.75, 2, 2.5, 5.5, 9.5, 25.5, 49.5,121.5, 217.5, 313.5,481.5 hours post-dose on day 1, and 0，1.5, 2.5 hours post-dose on day 22]
Eligibility criteria
Inclusion criteria
- 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) \[except for alopecia, pigmentation, peripheral sensory neuropathy, hypothyroidism, and other toxicities judged by the investigator to pose no safety risk\];
- Subjects with ECOG PS score of 0-1;
- Subjects with expected survival more than 3 months;
- 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
- 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;
- Patients with a history of alcohol or drug abuse or dependence, or a history of severe mental illness;
- The investigator considers the subject to be unsuitable for participation in this clinical trial due to any clinical or laboratory abnormalities.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07624864 · HM5087ST1S01