Chong Kun Dang pharmaceutical said on the 20th it began enrolling the first U.S. patient for global phase 1/2a trials of CKD-703, an antibody-drug conjugate (ADC)-based anticancer drug candidate.
The trial will be conducted at about 12 institutions in Korea and the United States, targeting patients with Non-small cell lung cancer (NSCLC) and various solid tumors. The first patient enrollment took place at the MD Anderson Cancer Center and the Gabrail Cancer Center in Ohio.
This study aims to assess the safety and maximum tolerated dose (MTD) of CKD-703 and to determine the optimal dose through proof of concept (POC).
CKD-703 is an ADC candidate that combines drug delivery technology with an antibody targeting c-Met, a protein involved in cancer cell growth, characterized by selectively attacking only cancer cells. The company received phase 1/2a approval from the U.S. Food and Drug Administration (FDA) in Jul. last year and clinical plan approval from the Ministery of Food and Drug Safety in Feb. this year, with patient enrollment set to begin in the first half. It plans to expand trial countries to Europe and beyond.
In preclinical studies, CKD-703 showed high binding affinity to c-Met, rapid intracellular delivery, stability in blood, and improved tolerability, as well as tumor suppression effects across various cancer models.
A Chong Kun Dang pharmaceutical official said, "The first U.S. patient enrollment shows the CKD-703 global trial is proceeding as planned," adding, "We will accelerate the development of competitive anticancer drugs based on our proprietary technology and ADC platform."