Actively Recruiting
A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of CS231295 in Subjects With Advanced Solid Tumors
Led by Chipscreen Biosciences, Ltd. · Updated on 2025-05-25
102
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating CS231295 in patients with advanced solid tumors, including glioblastoma and small cell lung carcinoma, to assess its safety, tolerability, and how the body processes the drug. This first-in-human study is designed in two phases: dose escalation and cohort expansion, aiming to find recommended doses for further studies. The trial is open-label and focuses on patients whose standard treatments have failed or are not suitable. The study involves oral administration of CS231295. During dose escalation, participants receive either a single dose or multiple daily doses, while in the cohort expansion phase, only multiple daily doses are given. Treatment continues until disease progression, intolerable side effects, withdrawal, or study end. The dose-limiting toxicity period is 6 days after single dose and 28 days after the first multiple dose cycle. Participants undergo screening, treatment, and follow-up periods. Researchers monitor for dose-limiting toxicities, adverse events, and pharmacokinetic properties through up to 11 treatment cycles of 28 days each. They also evaluate tumor responses and long-term outcomes such as progression-free and overall survival. Safety and tolerability are carefully observed throughout the study and after treatment completion.
CONDITIONS
Brief Title
Safety, Pharmacokinetics and Preliminary Efficacy of CS231295 in Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Understand and voluntarily sign the informed consent form.
- Be 18 years of age or older at the time of consent.
- Have histologically or cytologically confirmed unresectable advanced, recurrent, or metastatic solid tumors with no effective standard treatment available.
- Have documented disease progression by radiological or histopathological evidence.
- For glioblastoma: at least one measurable intracranial tumor lesion per RANO 2.0 criteria; for other tumors: at least one measurable lesion per RECIST v1.1.
- For glioblastoma: KPS score of 60 or higher; for other solid tumors: ECOG performance status of 0 or 1.
- Meet specified laboratory criteria for blood counts, liver and kidney function, coagulation, and urine protein.
- Expected survival of at least 12 weeks.
- For cohort expansion: confirmed small cell lung cancer after at least two lines of chemotherapy or recurrent/progressive glioblastoma after temozolomide treatment.
You will not qualify if you...
- Received intracranial radiotherapy within 3 months prior to first dose.
- Received anti-tumor treatment or investigational drugs within 28 days prior to first dose.
- Previously treated with Aurora kinase inhibitors.
- Used strong CYP3A enzyme inducers or inhibitors within 14 days prior or within 7 half-lives.
- For glioblastoma: use of >5 mg/day dexamethasone or equivalent glucocorticoids within 1 week prior.
- Major surgery within 28 days or unresolved wounds/fractures.
- Unresolved toxicities from prior treatments above grade 1 except alopecia or lab abnormalities.
- History of other primary cancers within 5 years except certain treated cancers.
- Unstable brain metastases or leptomeningeal metastasis except glioblastoma.
- Severe brain herniation or risk.
- Glioblastoma patients with wafer implantation during surgery.
- Recent drainage or symptoms from effusions.
- Significant uncontrolled cardiovascular disease or conditions.
- Poorly controlled diabetes.
- Significant gastrointestinal issues affecting drug intake.
- Recent significant bleeding or high bleeding risk.
- Serious thromboembolic events within 6 months.
- Active infections requiring IV treatment or severe infections recently.
- Active tuberculosis or hepatitis B/C with viral replication.
- HIV or syphilis infection.
- Allergy to trial drug components or severe allergic history.
- History of organ or stem cell transplantation.
- History of substance abuse.
- Psychiatric or cognitive disorders affecting consent or compliance.
- Unwilling or unable to use effective contraception if applicable.
- Other conditions judged unsuitable by investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 28-day cycles until disease progression or discontinuation
Participants receive the study drug CS231295. The treatment includes a single-dose period with one dose on Cycle 0 Day 1, followed by a multiple-dose period with once daily dosing from Cycle 1 Day 1 until disease progression, intolerable toxicity, withdrawal, or the end of the trial.
Visits occur during treatment cycles as per protocol up to 11 cycles
Trial Site Locations
Total: 2 locations
1
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100070
Not Yet Recruiting
2
Jilin Cancer Hospital
Changchun, Jilin, China, 130103
Actively Recruiting
Research Team
X
Xinhang Wang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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