Advanced Solid Tumor
Conditions
Brief summary
To evaluate the efficacy and safety of SPH7485 tablets in patients with advanced solid tumors.
Interventions
DRUGSPH7485
SPH7485： Orally, once daily, 50-400mg, 21 days per cycle
Sponsors
Shanghai Pharmaceuticals Holding 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. Histologically or cytologically confirmed advanced solid tumors； 2. At least one extracranial measurable lesion; 3. ECOG (Eastern Cooperative Oncology Group) performance status score of 0 or 1; 4. Subjects whose laboratory examination indicators meet the prescribed standards during the screening period; 5. Life expectancy≥3 months; 6. Subjects whose toxic reactions to previous antitumor therapy returned to baseline or CTCAE≤grade 1; 7. Female subjects whose pregnancy tests are negative; Male subjects agree not to donate sperm; Subject and partner agree to use reliable contraception; 8. Volunteer to participate in clinical research; Fully understand and know the study and sign the informed consent; Subjects willing to follow and able to complete all test procedures.
Exclusion criteria
1. Subjects who have received the prescribed other anti-tumor treatments at the prescribed time prior to the first dose; 2. Subjects who have received previous drugs with the same target; 3. Subjects with active infections requiring systemic treatment; 4. Subjects with third gap fluid accumulation that cannot be controlled by drainage or other methods; 5. Subjects with uncontrolled or severe cardiovascular disease; 6. Severe lung disease; 7. Subjects with conditions that may affect the absorption, distribution, metabolism, or excretion of the test drug; 8. Subjects taking strong/moderate inhibitors or inducers of CYP3A4; 9. Subjects who use or require long-term use of hormonotherapy before screening; 10. Subjects who have had other malignancies within the past 5 years; 11. Subjects with symptomatic CNS metastasis, pial metastasis, or spinal cord compression due to metastasis; 12. Subjects who have undergone or are scheduled to undergo major surgery, or have not yet recovered from surgery; 13. Abnormal virological examination during screening; History of immune deficiency; 14. Uncontrolled systemic diseases; 15. Subjects who have participated in any other clinical trial and received treatment within 21 days prior to the first dose; 16. Subjects who have received or plan to receive live or attenuated vaccines within 28 days prior to first dose; 17. Subjects with a history of severe allergy or known allergy to this product and its excipients; 18. Subjects who cannot follow the study protocol to complete the required study visit and dosing; 19. Subjects with a history of alcohol or drug abuse; 20. Lactating female patients; 21. Subjects with a clear past history of neurological or psychiatric disorders. Subjects with primary diseases of other vital organs deemed unsuitable for inclusion by the investigator; 22. Subjects deemed unsuitable for this clinical study by the investigator for other reasons.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| DLT(Dose-limiting toxicity) | Approximately 24 days | Measurement of DLT of SPH7485 in all subjects |
| Maximum tolerated dose（MTD） | Approximately 24 days | Measurement of MTD of SPH7485 in all subjects |
| Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Approximately 2 years | Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PFS(Progression-free survival) | Approximately 2 years | PFS was defined as the time interval between study treatment initiation and the first occurrence of progression disease or death, whichever occurred first. |
| PK(Pharmacokinetics):Tmax | Approximately 3 days | Time to peak plasma concentration (Tmax) |
| DCR(Disease Control Rate) | Approximately 2 years | DCR was defined as the percentage of patients who have achieved complete response, partial response and stable disease |
| PK(Pharmacokinetics):AUC | Approximately 3 days | Area under the plasma concentration versus time curve (AUC) |
| PK(Pharmacokinetics):Cmax | Approximately 3 days | Maximum serum concentration(Cmax) |
| ORR(Objective Response Rate) | Approximately 2 years | Tumor response will be evaluated according to the Response Evaluation Criteria Solid Tumors (RECIST) criteria version 1.1. |
| DoR(Duration of response) | Approximately 2 years | DOR was defined as the time interval between the date of the first documented response (CR or PR) and the date of the first documented disease progression or death due to any cause |
Countries
China
Contacts
Primary ContactXiaohua Wu
Backup ContactJian Zhang
Outcome results
None listed