A Study of CS231295 in Patients With Advanced Solid Tumors
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorThalassaX Therapeutics United States Ltd
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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).
Trial design
Treatments tested in this trial
- a small molecular multi-target kinase inhibitor
Treatment groups
42 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov