Actively Recruiting
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
Led by Shanghai Pharmaceuticals Holding Co., Ltd · Updated on 2025-08-17
170
Participants Needed
6
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying SPH7485 tablets in patients with advanced solid tumors to assess how well the tablets work and how safe they are. This phase 1 clinical trial focuses on finding the right dose and understanding the drug's effects on patients with this condition. The study is sponsored by Shanghai Pharmaceuticals Holding Co., Ltd and aims to gather important early data on SPH7485. Participants will take SPH7485 tablets orally once daily, with doses ranging from 50 to 400 mg for 21 days per treatment cycle. The study includes dose-escalation and dose-expansion phases to evaluate safety, tolerability, and pharmacokinetics. The trial will monitor dose-limiting toxicities and determine the maximum tolerated dose over about 24 days. During the study, participants will have regular assessments for adverse events, laboratory tests, and evaluations of tumor response lasting up to two years. Researchers will track objective response rate, disease control rate, progression-free survival, and pharmacokinetic parameters like Tmax and Cmax. Participants must follow all study procedures and attend scheduled visits to ensure thorough monitoring and data collection throughout the trial.
CONDITIONS
Brief Title
A Clinical Study of SPH7485 Tablets in the Treatment of Advanced Solid Tumors.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed advanced solid tumors
- At least one extracranial measurable lesion
- ECOG performance status score of 0 or 1
- Laboratory examination indicators meet prescribed standards during screening
- Life expectancy of at least 3 months
- Toxic reactions to previous antitumor therapy returned to baseline or are grade 1 or lower
- Female subjects with negative pregnancy tests; male subjects agree not to donate sperm
- Both subject and partner agree to use reliable contraception
- Volunteer to participate, fully understand the study, and sign informed consent
- Willing and able to complete all test procedures
You will not qualify if you...
- Received other prescribed anti-tumor treatments within the specified time before first dose
- Previous drugs with the same target
- Active infections requiring systemic treatment
- Uncontrolled third gap fluid accumulation
- Uncontrolled or severe cardiovascular disease
- Severe lung disease
- Conditions affecting absorption, distribution, metabolism, or excretion of the test drug
- Taking strong or moderate CYP3A4 inhibitors or inducers
- Long-term hormonotherapy before screening
- Other malignancies within the past 5 years
- Symptomatic CNS metastasis, pial metastasis, or spinal cord compression due to metastasis
- Recent or scheduled major surgery not yet recovered from
- Abnormal virological exam during screening or history of immune deficiency
- Uncontrolled systemic diseases
- Participation in another clinical trial with treatment within 21 days prior to first dose
- Live or attenuated vaccines within 28 days prior to first dose
- History of severe allergy to this product or its excipients
- Unable to follow study protocol or complete visits and dosing
- History of alcohol or drug abuse
- Lactating female patients
- History of neurological or psychiatric disorders or other vital organ diseases deemed unsuitable
- Any other reason deemed unsuitable by the investigator
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 21-day cycles until disease progression or discontinuation
Participants receive SPH7485 tablets orally once daily in 21-day cycles to treat advanced solid tumors.
Visits occur regularly throughout treatment cycles
Duration - Up to approximately 2 years
Participants are monitored for safety and efficacy outcomes after treatment completion.
Visits scheduled periodically during follow-up
Trial Site Locations
Total: 6 locations
1
XiangYa Hospital CentralSouth University
Changsha, China
Actively Recruiting
2
Fujian Cancer Hospital
Fuzhou, China
Actively Recruiting
3
Zhejiang Cancer Hospital
Hangzhou, China
Actively Recruiting
4
Yunnan Cancer Hospital
Kunming, China
Actively Recruiting
5
Fudan University Shanghai Cancer Center
Shanghai, China
Actively Recruiting
6
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China
Actively Recruiting
Research Team
X
Xiaohua Wu
J
Jian Zhang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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