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

Official title

An Open, Multicenter, Dose-escalation, and Dose-expansion Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Initial Efficacy of SPH7485 Tablets in Patients With Advanced Solid Tumors.

Overview

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

Interventions

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

Primary outcome measures

• DLT(Dose-limiting toxicity) [Time frame: Approximately 24 days]
• Maximum tolerated dose（MTD） [Time frame: Approximately 24 days]
• Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [Time frame: Approximately 2 years]

Secondary outcome measures (7)

• ORR(Objective Response Rate) [Time frame: Approximately 2 years]
• DoR(Duration of response) [Time frame: Approximately 2 years]
• DCR(Disease Control Rate) [Time frame: Approximately 2 years]
• PFS(Progression-free survival) [Time frame: Approximately 2 years]
• PK(Pharmacokinetics):Tmax [Time frame: Approximately 3 days]
• PK(Pharmacokinetics):Cmax [Time frame: Approximately 3 days]
• PK(Pharmacokinetics):AUC [Time frame: Approximately 3 days]

Eligibility criteria

Inclusion criteria

• 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 criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

China · 6 centers

• XiangYa Hospital CentralSouth University — Changsha
• Fujian Cancer Hospital — Fuzhou
• Zhejiang Cancer Hospital — Hangzhou
• Yunnan Cancer Hospital — Kunming
• Fudan University Shanghai Cancer Center — Shanghai
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan

Identifiers

NCT: NCT06487455 · SPH7485-101

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗