A Clinical Study of SPH7485 Tablets in the Treatment of Advanced Solid Tumors.

Shanghai Pharmaceuticals

Status and phase: Enrolling; Phase 1

Conditions: Advanced Solid Tumor

Treatments: Drug: SPH7485

Study type: Interventional

Funder types: Industry

Identifiers

NCT06487455

SPH7485-101

Details and patient eligibility

About

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

Enrollment: 170 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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170 participants in 1 patient group

SPH7485

Experimental group

Treatment:

Drug: SPH7485