Holy Stone Healthcare Co., Ltd. has submitted IND for phase I clinical trial of its new drug for colorectal cancer, CA102N, to the US FDA on September 26; and was informed of the approval by FDA on October 27.
CA102N is a hyaluronic acid conjugated drug, developed based on the company’s Hyaluronan Drug Delivery (HDD) platform, and Hyaluronic Acid Conjugated Drugs (HACD) technology. It exhibits tumor-targeting delivery and reduces tumor growth via multi-pathway inhibition, and is being evaluated for treatment of colorectal cancer.
The above-mentioned trial is a phase I, two-part (dose escalation and dose expansion) study to evaluate safety and tolerability of CA102N in colorectal cancer patients, as well as to determine the preliminary recommended phase 2 dose (RP2D). The pharmacokinetic data of CA102N will also be collected and characterized.
The phase I study is planned to recruit 33-57 subjects. It will be conducted in 3 medical centers in the US: The University of Texas M. D. Anderson Cancer Center, Banner MD Anderson Cancer Center, and University of Colorado Cancer Center. An Investigator Meeting was held on September 27, 2018, at the Hilton Houston Plaza/Medical Center. The enrollment of subject is planned to commence in 2019 and complete in 2020 (2 years). The actual completion date is subject to enrollment conditions.