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Trial Title:
A Clinical Study of SPH7485 Tablets in the Treatment of Advanced Solid Tumors.
NCT ID:
NCT06487455
Condition:
Advanced Solid Tumor
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
SPH7485
Description:
SPH7485： Orally, once daily, 50-400mg, 21 days per cycle
Arm group label:
SPH7485
Summary:
To evaluate the efficacy and safety of SPH7485 tablets in patients with advanced solid
tumors.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
XiangYa Hospital CentralSouth University
Address:
City:
Changsha
Country:
China
Status:
Recruiting
Contact:
Last name:
Yan Tian
Contact backup:
Last name:
Dai Li
Facility:
Name:
Fujian Cancer Hospital
Address:
City:
Fuzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
An Lin
Facility:
Name:
Zhejiang Cancer Hospital
Address:
City:
Hangzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Jianqing Zhu
Facility:
Name:
Yunnan Cancer Hospital
Address:
City:
Kunming
Country:
China
Status:
Recruiting
Contact:
Last name:
Hongying Yang
Facility:
Name:
Fudan University Shanghai Cancer Center
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiaohua Wu
Contact backup:
Last name:
Jian Zhang
Facility:
Name:
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Address:
City:
Wuhan
Country:
China
Status:
Recruiting
Contact:
Last name:
Guiling Li
Start date:
August 6, 2024
Completion date:
December 31, 2027
Lead sponsor:
Agency:
Shanghai Pharmaceuticals Holding Co., Ltd
Agency class:
Industry
Source:
Shanghai Pharmaceuticals Holding Co., Ltd
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06487455
