ThalassaX Therapeutics United States Ltd
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.
In this dose-escalation study, the "3+3" design will be employed for dose escalation decisions. 4 dose groups have been preset: 20 mg, 30 mg, 40 mg, 50 mg\[LA2.1\]. The starting dose is 20 mg, with each dose cohort enrolling 3-6 subjects. Each subject can participate in only one dosage group of the study. During the dose escalation, depending on the observed results of safety, pharmacokinetics (PK), and pharmacodynamics (PD), dose levels may be adjusted or removed, additional dose levels may be added and explored, including intermediate or higher dose levels or other dosing regimens. The dose…
Inclusion Criteria: Patients are eligible to be included in the study only if all of the following criteria apply: 1. 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. 2. Male or female ≥18 years at the time of Screening. 3. Histologically or cytologically confirmed unresectable advanced, recurrent or metastatic solid tumors (including but not limited to small cell lung cancer (SCLC), b…
CS231295 is a small-molecule, multi-target protein kinase inhibitor that exhibits balanced activity against both Aurora B kinase and VEGFR/PDGFR kinases.