Status:
RECRUITING
A Clinical Study of SPH7485 Tablets in the Treatment of Advanced Solid Tumors.
Lead Sponsor:
Shanghai Pharmaceuticals Holding Co., Ltd
Conditions:
Advanced Solid Tumor
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
To evaluate the efficacy and safety of SPH7485 tablets in patients with advanced solid tumors.
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed advanced solid tumors；
- At least one extracranial measurable lesion;
- ECOG (Eastern Cooperative Oncology Group) performance status score of 0 or 1;
- Subjects whose laboratory examination indicators meet the prescribed standards during the screening period;
- Life expectancy≥3 months;
- Subjects whose toxic reactions to previous antitumor therapy returned to baseline or CTCAE≤grade 1;
- Female subjects whose pregnancy tests are negative; Male subjects agree not to donate sperm; Subject and partner agree to use reliable contraception;
- 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
- Subjects who have received the prescribed other anti-tumor treatments at the prescribed time prior to the first dose;
- Subjects who have received previous drugs with the same target;
- Subjects with active infections requiring systemic treatment;
- Subjects with third gap fluid accumulation that cannot be controlled by drainage or other methods;
- Subjects with uncontrolled or severe cardiovascular disease;
- Severe lung disease;
- Subjects with conditions that may affect the absorption, distribution, metabolism, or excretion of the test drug;
- Subjects taking strong/moderate inhibitors or inducers of CYP3A4;
- Subjects who use or require long-term use of hormonotherapy before screening;
- Subjects who have had other malignancies within the past 5 years;
- Subjects with symptomatic CNS metastasis, pial metastasis, or spinal cord compression due to metastasis;
- Subjects who have undergone or are scheduled to undergo major surgery, or have not yet recovered from surgery;
- Abnormal virological examination during screening; History of immune deficiency;
- Uncontrolled systemic diseases;
- Subjects who have participated in any other clinical trial and received treatment within 21 days prior to the first dose;
- Subjects who have received or plan to receive live or attenuated vaccines within 28 days prior to first dose;
- Subjects with a history of severe allergy or known allergy to this product and its excipients;
- Subjects who cannot follow the study protocol to complete the required study visit and dosing;
- Subjects with a history of alcohol or drug abuse;
- Lactating female patients;
- 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;
- Subjects deemed unsuitable for this clinical study by the investigator for other reasons.
Key Trial Info
Start Date :
August 6 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT06487455
Start Date
August 6 2024
End Date
December 31 2027
Last Update
August 17 2025
Active Locations (6)
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1
XiangYa Hospital CentralSouth University
Changsha, China
2
Fujian Cancer Hospital
Fuzhou, China
3
Zhejiang Cancer Hospital
Hangzhou, China
4
Yunnan Cancer Hospital
Kunming, China