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

Phase 1

Recruiting

• Conditions: Advanced Solid Tumor
• Interventions: Drug: SPH7485

• Registration Number: NCT06487455
• Lead Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-06-27
• Study First Submitted QC: 2024-06-27
• Study First Posted: 2024-07-05
• Last Update Submitted: 2024-08-05
• Study Start: 2024-08-06
• Last Update Posted: 2024-08-07
• Primary Completion: 2027-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 170

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SPH7485	SPH7485	-

Primary Outcome Measures

Name	Time	Method
Maximum tolerated dose（MTD）	Approximately 24 days	Measurement of MTD of SPH7485 in all subjects
DLT(Dose-limiting toxicity)	Approximately 24 days	Measurement of DLT of SPH7485 in all subjects
Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)	Approximately 2 years	Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

Secondary Outcome Measures

Name	Time	Method
ORR(Objective Response Rate)	Approximately 2 years	Tumor response will be evaluated according to the Response Evaluation Criteria Solid Tumors (RECIST) criteria version 1.1.
DCR(Disease Control Rate)	Approximately 2 years	DCR was defined as the percentage of patients who have achieved complete response, partial response and stable disease
PK(Pharmacokinetics):Cmax	Approximately 3 days	Maximum serum concentration(Cmax)
DoR(Duration of response)	Approximately 2 years	DOR was defined as the time interval between the date of the first documented response (CR or PR) and the date of the first documented disease progression or death due to any cause
PK(Pharmacokinetics):Tmax	Approximately 3 days	Time to peak plasma concentration (Tmax)
PK(Pharmacokinetics):AUC	Approximately 3 days	Area under the plasma concentration versus time curve (AUC)
PFS(Progression-free survival)	Approximately 2 years	PFS was defined as the time interval between study treatment initiation and the first occurrence of progression disease or death, whichever occurred first.

Trial Locations

Locations (6)

XiangYa Hospital CentralSouth University; 🇨🇳 Changsha, China

Fujian Cancer Hospital; 🇨🇳 Fuzhou, China

Yunnan Cancer Hospital; 🇨🇳 Kunming, China

Zhejiang Cancer Hospital; 🇨🇳 Hangzhou, China

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, China

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology; 🇨🇳 Wuhan, China