A Study of CS231295 in Patients With Advanced Solid Tumors

Starting soon · Phase 1

Conditions studied: Advance Solid Tumors, Advanced Malignant Solid Tumors

In brief

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.

Key facts

Study ID

NCT07612488

Run by

ThalassaX Therapeutics United States Ltd

People needed

42

Starts

2026-06-01

Expected to finish

2028-12-01

Last updated by the study team

2026-05-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients are eligible to be included in the study only if all of the following criteria apply:
• 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.
• Treatment failure must be documented by clear imaging or cell histopathology (such as cytology reports of new ascites or pleural effusion) to prove disease progression.
• Intolerance is defined as the termination of treatment due to adverse events that occur during treatment.
• Recurrence is based on imaging or cell histopathology results.
• At least one measurable target lesion (glioma, according to RANO 2.0; other solid tumors according to RECIST v1.1).
• Note: The target lesion can be located in an area that has previously undergone radiotherapy. However, imaging examinations are required to confirm disease progression at the site after radiotherapy.
• 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:
• (No blood components, hematopoietic growth factors, albumin, or other drugs deemed corrective treatment by the investigators should be used within 14 days prior to the screening, except for iron supplements.)
• Hematology:
• Absolute neutrophil count (ANC) ≥ 1.5 × 10\^9/L,
• platelets ≥ 100 × 10\^9/L,
• hemoglobin ≥ 100 g/L
• Biochemistry:
• Total serum bilirubin ≤ 1.5 x ULN (< 3.0 x ULN for patients with Gilbert's syndrome).
• In patients without hepatic metastasis: ALT and AST ≤1.5 × ULN.
• In patients with hepatic metastases, ALT and AST ≤3 × ULN.
• Measured or calculated creatinine clearance > 60 mL/min (according to the Cockcroft-Gault equation, using actual body weight)
• Coagulation Function: International Normalized Ratio (INR) < 1.5 × ULN; Prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN (for subjects receiving prophylactic anticoagulation therapy, the investigator should judge that both INR and APTT are within the safe and effective therapeutic range).
• Urine protein < 2+ by urinalysis. If patients have urine protein ≥2+ by urinalysis, a 24-hour urine protein quantification test should be performed. The patient cannot be enrolled if the quantified urine protein is ≥1 g/24 h. The patient can still be enrolled if the quantified urine protein is <1 g/24 h.
• Women of childbearing potential (WOCBP) must be willing and able to take highly effective contraceptive measures during the entire study treatment period and for 12 weeks after the last dose of the study drug (see Appendix 13.3 for details). Women of childbearing potential include premenopausal and not sterilized (by hysterectomy, bilateral ligation of fallopian tubes, or bilateral oophorectomy) females who have passed menarche.

You may not qualify if…

• Patients are excluded from the study if any of the following criteria apply:
• 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
• Malignancy treated with curative intent and with no known active disease ≥ 5 years before the first dose of the study drug and of low potential risk for recurrence
• Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
• Adequately treated carcinoma in situ without evidence of disease
• Advanced solid tumors other than glioma: Patients with active or untreated brain metastases, leptomeningeal metastases, spinal cord compression, or leptomeningeal carcinomatosis at the screening are excluded. Participants with previous brain metastases may participate only if they satisfy all of the following:
• Has completed treatment (e.g., whole brain radiation treatment [WBRT], stereotactic radiosurgery, or equivalent)
• Have stable disease for more than 4 weeks at the screening tumor assessment as confirmed by MRI or CT brain (defined as 2 brain images, both of which are obtained after treatment to the brain metastases. These imaging scans should both be obtained at least four weeks apart and show no evidence of intracranial progression).
• Have been either off corticosteroids or on a stable or decreasing dose of 10 mg daily prednisone (or equivalent) for at least 2 weeks before the first dose of study medications.
• Have been off anticonvulsants for at least 2 weeks before the first dose of study medications.
• Combined with meningeal metastasis, except for glioma.
• Has severe brain herniation or a risk of brain herniation.
• Glioma: had a chip implant placed during glioma surgery.
• Pleural effusion, ascites, or pericardial effusion that have been drained within 1 month before the first dose of the study drug, or significant clinical symptoms (such as chest tightness, shortness of breath, dyspnea, etc.).
• Uncontrolled or significant cardiovascular diseases, including:
• New York Heart Association (NYHA) grade II or higher congestive cardiac failure, unstable angina pectoris, and/or myocardial infarction within the 6 months prior to the first dose of the investigational drug, clinically significant arrhythmia unable to be controlled with medical treatment or left ventricular ejection fraction (LVEF) < 50% at screening.
• Primary cardiomyopathies (e.g., dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, indeterminate cardiomyopathy).
• Clinically significant history of prolonged QTc interval, or QTcF interval ≥470 ms, regardless of sex, during screening. If the report does not include a QTcF result, it must be calculated using the Fridericia correction formula (Fridericia QTc = QT/RR\^0.33).

Where it is running

• Sarah Cannon Research Institute at HealthONE — Denver, Colorado, United States
• Florida Cancer Specialists — Sarasota, Florida, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• SCRI Oncology Partners — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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