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

NCT06487455 | Recruiting Phase 1

• 1 other identifier: SPH7485-101
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 6

Brief Summary

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

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (3)

• DLT(Dose-limiting toxicity)

  Measurement of DLT of SPH7485 in all subjects

  Approximately 24 days

• Maximum tolerated dose（MTD）

  Measurement of MTD of SPH7485 in all subjects

  Approximately 24 days

• Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

  Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

  Approximately 2 years

Secondary Outcomes (7)

• ORR(Objective Response Rate)

  Approximately 2 years

• DoR(Duration of response)

  Approximately 2 years

• DCR(Disease Control Rate)

  Approximately 2 years

• PFS(Progression-free survival)

  Approximately 2 years

• PK(Pharmacokinetics):Tmax

  Approximately 3 days

Study Arms (1)

SPH7485

EXPERIMENTAL

Drug: SPH7485

Interventions

SPH7485 DRUG

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

SPH7485

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Shanghai Pharmaceuticals Holding Co., Ltd: lead

Study Sites (6)

XiangYa Hospital CentralSouth University

Changsha, China

RECRUITING

Fujian Cancer Hospital

Fuzhou, China

RECRUITING

Zhejiang Cancer Hospital

Hangzhou, China

RECRUITING

Yunnan Cancer Hospital

Kunming, China

RECRUITING

Fudan University Shanghai Cancer Center

Shanghai, China

RECRUITING

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

Wuhan, China

RECRUITING

Central Study Contacts

Xiaohua Wu

CONTACT

0086-021-34778299; shanboer@126.com

Jian Zhang

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2024
• First Posted: July 5, 2024
• Study Start: August 6, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 17, 2025

Record last verified: 2025-08

Locations

CN (6)