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

NCT ID: NCT06487455

Last Updated: 2025-08-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 170 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-06
• Study Completion Date: 2027-12-31

Brief Summary

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

Conditions

Advanced Solid Tumor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SPH7485

Group Type: EXPERIMENTAL

SPH7485

Intervention Type: DRUG

SPH7485： Orally, once daily, 50-400mg, 21 days per cycle

Interventions

SPH7485

SPH7485： Orally, once daily, 50-400mg, 21 days per cycle

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Pharmaceuticals Holding Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

XiangYa Hospital CentralSouth University

Changsha, , China

Site Status: RECRUITING

Fujian Cancer Hospital

Fuzhou, , China

Site Status: RECRUITING

Zhejiang Cancer Hospital

Hangzhou, , China

Site Status: RECRUITING

Yunnan Cancer Hospital

Kunming, , China

Site Status: RECRUITING

Fudan University Shanghai Cancer Center

Shanghai, , China

Site Status: RECRUITING

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiaohua Wu

Role: CONTACT

shanboer@126.com

0086-021-34778299

Jian Zhang

Role: CONTACT

Facility Contacts

Yan Tian

Role: primary

Dai Li

Role: backup

An Lin

Role: primary

Jianqing Zhu

Role: primary

Hongying Yang

Role: primary

Xiaohua Wu

Role: primary

Jian Zhang

Role: backup

Guiling Li

Role: primary

Other Identifiers

SPH7485-101

Identifier Type: -

Identifier Source: org_study_id