A Study of CS231295 in Patients With Advanced Solid Tumors (NCT07612488) | Clinical Trial Compass
Not Yet RecruitingPhase 1
A Study of CS231295 in Patients With Advanced Solid Tumors
United States42 participantsStarted 2026-06
Plain-language summary
This is a Phase I, single-arm, open-label, dose-escalation, multicenter clinical study of CS231295 in patients with advanced solid malignant tumors.
Eligible patients must be 18 years or older and have histologically or cytologically confirmed unresectable advanced, recurrent, or metastatic solid tumors, who have failed or are intolerant to previous standard treatments and currently have no other standard treatment options available. Patients should have at least one measurable target lesion (glioma, according to RANO 2.0; other solid tumors according to RECIST v1.1) and a Karnofsky Performance Status (KPS) score ≥ 60 (glioma) or an ECOG Performance Status score of 0 or 1 (other solid tumors).
After screening, eligible patients will be enrolled sequentially in the dose-escalating cohorts.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Subject provides voluntary informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol prior to performing any protocol-related procedures, including screening evaluations.
. Male or female ≥18 years at the time of Screening.
. Histologically or cytologically confirmed unresectable advanced, recurrent or metastatic solid tumors (including but not limited to small cell lung cancer (SCLC), brain gliomas, non-small cell lung cancer (NSCLC), pancreatic cancer, urothelial carcinoma, endometrial cancer, cervical cancer, ovarian cancer, breast cancer and liver cancer, etc.), who have failed or are intolerant to previous standard treatment (assessed by the investigator according to the diagnosis and treatment guidelines of the relevant disease) and currently have no standard treatment.
. At least one measurable target lesion (glioma, according to RANO 2.0; other solid tumors according to RECIST v1.1).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence and severity of adverse events (AEs)
Timeframe: From first dose administration to 28 days after the end of treatment.
2
Dose Limiting Toxicity (DLT)
Timeframe: 34 days. From the first dose of 6-day single dose period to the last dose of the 28-day consecutive multiple dose period.
3
Maximum Tolerated Dose (MTD)
Timeframe: Dose escalation period. 2 years.
4
Pharmacokinetic parameters: Time to Maximum Concentration (Tmax)
Timeframe: During treatment, up to 11 cycles. 28 days in one cycle.
5
Pharmacokinetic parameters: Maximum Concentration (Cmax)
Timeframe: During treatment, up to 11 cycles. 28 days in one cycle.
6
Pharmacokinetic parameters: Area Under the Concentration-time Curve (AUC)
Timeframe: During treatment, up to 11 cycles. 28 days in one cycle.
. Glioma: KPS score ≥ 60 points; other solid tumors: ECOG performance status score of 0 or 1 points.
. Life expectancy of ≥ 12 weeks.
. Major organ functions meet the following criteria:
. Hematology:
Exclusion criteria
. Received any form of intracranial radiotherapy within a specified time frame before the first dose of medication: 3 months for glioma and 2 weeks for other solid tumors.
. Any prior anti-tumor treatment such as radiotherapy (exclusion criterion #1 if intracranial radiotherapy), chemotherapy, immunotherapy, targeted therapy, cell therapy, endocrine anti-tumor therapy, tumor embolization, clinical trial drugs or devices that have not been approved for marketing, etc., within 28 days before the first medication.
. Patients have previously received treatment with Aurora kinase inhibitors.
. Has used a strong inducer or inhibitor of cytochrome P450 3A enzyme (CYP3A) within 14 days before the first dose of the study drug or is still within 7 half-lives of the drug (whichever is longer).
. Glioma: Use of \> 5 mg/d dexamethasone or equivalent doses of other glucocorticoids for systemic treatment related to glioma within 1 week before the first dose.
. Major surgical procedures (craniotomy, thoracotomy, or laparotomy) or severe unhealed wounds, ulcers, or fractures performed within 4 weeks before the first dose of study medication.
. Any unresolved toxicity from previous anticancer therapy, defined as toxicities not yet resolved to NCI CTCAE Grade ≤1, except for alopecia or laboratory values deemed by the investigator to be of no clinical significance.
. History of another primary malignancy except for
Timeframe: During treatment, up to 11 cycles. 28 days in one cycle.
8
Pharmacokinetic parameters: Accumulation Ratio (Rac)
Timeframe: During treatment, up to 11 cycles. 28 days in one cycle.