Clinical trial NCT06487455: A Clinical Study of SPH7485 Tablets in the Treatment of Advanced Solid Tumors.
Official title: An Open, Multicenter, Dose-escalation, and Dose-expansion Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Initial Efficacy of SPH7485 Tablets in Patients with Advanced Solid Tumors.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Advanced Solid Tumor
Lead sponsor: Shanghai Pharmaceuticals Holding Co., Ltd
Sponsor class: INDUSTRY
First posted: 2024-07-05
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy and safety of SPH7485 tablets in patients with advanced solid tumors.


Eligibility criteria: 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.

Primary outcomes:
measure: DLT(Dose-limiting toxicity)
timeFrame: Approximately 24 days
measure: Maximum tolerated dose（MTD）
timeFrame: Approximately 24 days
measure: Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
timeFrame: Approximately 2 years
Secondary outcomes:
measure: ORR(Objective Response Rate)
timeFrame: Approximately 2 years
measure: DoR(Duration of response)
timeFrame: Approximately 2 years
measure: DCR(Disease Control Rate)
timeFrame: Approximately 2 years
measure: PFS(Progression-free survival)
timeFrame: Approximately 2 years
measure: PK(Pharmacokinetics):Tmax
timeFrame: Approximately 3 days
measure: PK(Pharmacokinetics):Cmax
timeFrame: Approximately 3 days
measure: PK(Pharmacokinetics):AUC
timeFrame: Approximately 3 days
Other outcomes:
Locations:
city: Changsha
country: China
facility: XiangYa Hospital CentralSouth University
city: Fuzhou
country: China
facility: Fujian Cancer Hospital
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
city: Kunming
country: China
facility: Yunnan Cancer Hospital
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
city: Wuhan
country: China
facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Study officials:
References: