CS-231295 / Chipscreen - LARVOL DELTA

A Study of CS231295 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=42 | Not yet recruiting | Sponsor: ThalassaX Therapeutics United States Ltd

New P1 trial • Breast Cancer • Endometrial Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor

CS231295, a novel AURKB-biased multi-kinase inhibitor, demonstrates synthetic lethality in RB1-deficient tumors and potent intracranial efficacy (AACR 2026) - "CS231295 achieves effective AURKB inhibition at doses concurrently modulating angiogenesis, overcoming a key limitation of prior agents. Its synthetic lethality with RB1 deficiency and marked intracranial efficacy support its therapeutic potential for RB1-deficient malignancies and brain-involved tumors. IND approvals have been obtained in China and the U.S., facilitating global clinical development."

Clinical • Synthetic lethality • Brain Cancer • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • AURKB • CASP3 • CASP9 • RB1

Chipscreen Biosciences' Brain-Penetrant Aurora B Selective Inhibitor CS231295 Tablet Receives FDA IND Approval, Advancing Global Clinical Development (The Manila Times) - "Shenzhen Chipscreen Biosciences Co...announced that its wholly owned subsidiary, Chipscreen Biosciences (USA) Ltd., has received Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA) for its innovative drug CS231295 tablet for the treatment of advanced solid tumors. This significant milestone marks a key step forward in the global development strategy for CS231295...Notably, CS231295 completed the first patient enrollment in its Phase I first-in-human clinical trial in China in May 2025, providing preliminary evidence to support the scientific rationale and feasibility of global multicenter clinical development."

IND • Trial status • Glioblastoma • Small Cell Lung Cancer • Solid Tumor

Safety, Pharmacokinetics and Preliminary Efficacy of CS231295 in Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=102 | Recruiting | Sponsor: Chipscreen Biosciences, Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Brain Cancer • Glioblastoma • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Safety, Pharmacokinetics and Preliminary Efficacy of CS231295 in Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=102 | Not yet recruiting | Sponsor: Chipscreen Biosciences, Ltd.

New P1 trial • Brain Cancer • CNS Tumor • Glioblastoma • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Chipscreen Biosciences' Innovative Anti-Tumor Drug CS231295 Tablets: Investigational New Drug (IND) Application Accepted (PRNewswire) - "On October 17, 2024, Shenzhen Chipscreen Biosciences Co., Ltd...submitted the company's Investigational New Drug (IND) application for CS231295 tablets, a Class 1 innovative drug for the treatment of tumors. The application has been accepted by the Center for Drug Evaluation of National Medical Products Administration of China (Application Number: CXHL2401105, CXHL2401107, CXHL2401108)."

New trial • Brain Cancer • CNS Tumor • Oncology • Solid Tumor

Chipscreen Biosciences’ Innovative Anti-Tumor Drug CS231295 Tablets: Investigational New Drug (IND) Application Accepted (PRNewswire) - "On October 17, 2024, Shenzhen Chipscreen Biosciences Co., Ltd...submitted the company's Investigational New Drug (IND) application for CS231295 tablets, a Class 1 innovative drug for the treatment of tumors. The application has been accepted by the Center for Drug Evaluation of National Medical Products Administration of China (Application Number: CXHL2401105, CXHL2401107, CXHL2401108)."

IND • Oncology • Solid Tumor