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
DRUGHemay5087
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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with adverse events | 3 weeks of treatment |
| Incidence of dose-limiting toxicity (DLT) in each dose group | 3 weeks of treatment |
| Maximum tolerated dose (MTD) or Maximum climbing dose (MAD) of Hemay181 | 3 weeks of treatment |
| Subsequent recommended doses of Hemay181 | 3 weeks of treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate | 3 weeks of treatment | — |
| Duration of Response | 3 weeks of treatment | — |
| Disease Control Rate | 3 weeks of treatment | — |
| Time to Response | 3 weeks of treatment | — |
| Progression-Free Survival | 3 weeks of treatment | — |
| Maximum Plasma Concentration （Cmax） | 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 | Pharmacokinetic (PK) profile |
| Time to reach maximum concentration （Tmax） | 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 | Pharmacokinetic (PK) profile |
| Elimination half life(t1/2) | 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 | Pharmacokinetic (PK) profile |
| Plasma Clearance（CL) | 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 | Pharmacokinetic (PK) profile |
| Mean Residence Time from 0 to last time of quantifiable concentration(MRT 0-t) | 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 | Pharmacokinetic (PK) profile |
| Mean Residence Time from 0 to infinite time(MRT 0-∞) | 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 | Pharmacokinetic (PK) profile |
| Area under the plasma concentration-time curve from 0 to last time of quantifiable concentration(AUC 0-t) | 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 | Pharmacokinetic (PK) profile |
| Area under the plasma concentration-time curve from 0 extrapolated to infinite time(AUC 0-∞) | 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 | Pharmacokinetic (PK) profile |
| Percentage of the residual area (AUC%Extra) | 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 | Pharmacokinetic (PK) profile |
| Volume of distribution(Vz) | 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 | Pharmacokinetic (PK) profile |
| Elimination rate constant(λz) | 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 | Pharmacokinetic (PK) profile |
Contacts
CONTACTjingyi xu
Outcome results
None listed