The pilot will focus on studying the tolerability, safety, anti-tumor efficacy and pharmacokinetics of CS3002 in subjects with advanced solid tumors.

CStone Pharmaceuticals, a biopharmaceutical company in China, has recently announced that it has secured an ethics approval for the Phase I clinical trial of CS3002 from the Human Research Ethics Committee in Australia, and has also received an electronic Clinical Trial Notification (eCTN) from Australias Therapeutic Goods Administration (TGA).

For the record, CStone’s CS3002 is a selective inhibitor of the cyclin-dependent kinases 4 and 6 (CDK4/6). By promoting cell cycle arrest of tumor cells through the careful inhibition of CDK4/6, CS3002 has showcased high therapeutic potential for combination with immune checkpoint inhibitor therapy or endocrine therapy in various solid tumors.

According to preclinical studies, CS3002 when combined with endocrine therapy or PD-1 monoclonal antibody therapy has shown advanced tumor-suppressing activities as compared to monotherapies. Furthermore, CS3002 has recorded a favorable safety and tolerability profiles.

Currently, the U.S. FDA has approved three CDK4/6 inhibitors. However, China only has one approved CDK4/6 inhibitor dubbed palbociclib which is suitable for the treatment of hormone receptor-positive (HR+), for metastatic breast cancer infused with aromatase inhibitor as initial hormone therapy in postmenopausal women, or for human epidermal growth factor receptor 2 negative (HER2-) advanced.

According to a statement, Dr. Frank Jiang MD, PhD., CEO and Chairman, CStone Pharmaceuticals, said that there are various CDK4/6 inhibitors that are in clinical development, but these options have yet to reach or limited for patients in China.

He said that the company is focusing on initiating its study in Australia. Moreover, the firm will accelerate its work in a bid to obtain an approval from the Chinese authorities and actively explore CS3002’s application in the treatment of numerous tumor types and different combination therapies, thereby creating an effective treatment option for Chinese patients.

Source Credit: https://www.prnewswire.com/news-releases/cstone-completes-registration-filing-for-the-phase-i-trial-of-cdk46-inhibitor-cs3002-in-australia-and-will-soon-initiate-the-study-300906227.html