Actively Recruiting
Safety, Pharmacokinetics and Preliminary Efficacy of CS231295 in Advanced Solid Tumors
Led by Chipscreen Biosciences, Ltd. · Updated on 2025-05-25
102
Participants Needed
2
Research Sites
201 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This trial is a single-arm, open-label, first-in-human study of CS231295, comprising two phases: dose escalation (including single-dose and multiple-dose) and cohort expansion. The Dose-Limiting Toxicity (DLT) observation period includes 6 days for single-dose and the first cycle (28 days) for multiple-dose. The overall study consists of screening period, treatment period, and follow-up period. The primary objectives of this study are to evaluate the safety, tolerability and pharmacokinetic (PK) characteristics of CS231295 in patients with advanced solid tumors, and to recommended Phase 2 dose(s) (RP2D) of CS231295 in appropriate tumor(s).
CONDITIONS
Official 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.
- Aged 18 years or older at the time of consent.
- Have histologically or cytologically confirmed unresectable advanced, recurrent, or metastatic solid tumors with no available standard treatment.
- Documented disease progression by radiological or histopathological evidence.
- For glioblastoma: at least one measurable intracranial tumor lesion per RANO 2.0 criteria; for other solid tumors: at least one measurable lesion per RECIST v1.1 criteria.
- For glioblastoma: Karnofsky Performance Status (KPS) score of 60 or higher; for other 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 phase: confirmed small cell lung cancer after at least two lines of chemotherapy, or recurrent/progressive glioblastoma after at least one prior temozolomide treatment.
You will not qualify if you...
- Received intracranial radiotherapy within 3 months prior to first dose.
- Received any anti-tumor treatment or unapproved investigational drugs within 28 days prior to first dose.
- Previous treatment with Aurora kinase inhibitors.
- Use of strong CYP3A enzyme inducers or inhibitors within specified time frames before dosing.
- For glioblastoma: use of more than 5 mg/day dexamethasone or equivalent glucocorticoids within 1 week before first dose.
- Major surgery within 28 days prior to first dose or unresolved wounds, ulcers, or fractures.
- Unresolved toxicities from prior treatments above grade 1 (except alopecia or non-significant lab abnormalities).
- History of other primary cancers within 5 years except certain treated cases.
- Unstable brain metastases (exceptions apply).
- Leptomeningeal metastasis (except glioblastoma).
- Severe brain herniation or risk thereof.
- Wafer implantation during glioblastoma surgery.
- Recent drainage of pleural, pericardial, or ascitic effusions or significant related symptoms.
- Uncontrolled or significant cardiovascular diseases.
- Poorly controlled diabetes.
- Gastrointestinal conditions affecting drug intake or absorption.
- Recent significant bleeding or high-risk bleeding conditions.
- Serious thromboembolic events within 6 months.
- Active infections requiring IV treatment or recent severe infections.
- Active tuberculosis or viral hepatitis infections.
- HIV or syphilis infection.
- Allergy or severe hypersensitivity to trial drug components.
- History of organ transplantation.
- History of alcohol or drug abuse.
- Psychiatric or cognitive disorders limiting study participation.
- Inability or unwillingness to use effective contraception during and after treatment.
- Other investigator-determined unsuitable conditions for trial participation.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here