A Phase 1, Single-Arm, Open-Label, Dose-Escalation, Multicenter Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of CS231295 in Patients With Advanced Solid Malignant Tumors
ThalassaX Therapeutics United States Ltd
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.
Description
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…
Eligibility
- Age range