LigaChem Biosciences has initiated full-scale clinical development of its in-house antibody-drug conjugate (ADC) candidate LCB02A, which targets Claudin18.2 (CLDN18.2), by completing the first patient dosing in a global clinical trial.
The company announced on Friday that it had administered the first dose to a patient in the global Phase 1/2 trial of LCB02A at a major clinical site in North America on Thursday.
LCB02A is an ADC candidate targeting the CLDN18.2 protein, which is expressed in solid tumors such as gastric and pancreatic cancers. LigaChem Biosciences submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) in April and received approval in May.
This clinical trial will enroll up to 191 patients with CLDN18.2-positive advanced solid tumors who have failed standard treatments. The study will be conducted at leading cancer centers in North America and South Korea.
The Phase 1 portion of the trial aims to assess the drug’s safety and tolerability and determine the recommended Phase 2 dose (RP2D). Subsequently, the Phase 2 portion will evaluate the anti-tumor effects in patients with CLDN18.2-expressing solid tumors, including gastric cancer, gastroesophageal junction cancer, and pancreatic cancer.
LCB02A incorporates LigaChem Biosciences’ proprietary ADC platform ConjuAll. The drug combines an antibody that recognizes CLDN18.2 with exatecan, a compound that inhibits topoisomerase 1 (Topo1), an enzyme involved in cancer cell DNA replication.
The company reports that it has enhanced the drug’s stability in the bloodstream using its proprietary linker technology and achieved a uniform drug-antibody ratio (DAR) of 4, meaning four drug molecules are attached to each antibody.
ADCs are innovative therapies that link potent anti-cancer drugs to antibodies that recognize specific proteins on cancer cells. This approach aims to deliver the drug directly to cancer cells, potentially increasing efficacy while minimizing side effects on healthy tissues.
CLDN18.2 has emerged as a promising new target for cancer therapy, particularly in gastric and pancreatic cancers.
LigaChem Biosciences will present research findings related to LCB02A at the upcoming European Society for Medical Oncology (ESMO Congress 2026) annual meeting in Madrid, Spain, from October 23 to 27.
At the conference, the company plans to present two posters detailing LCB02A’s preclinical research results and the design of the ongoing global Phase 1/2 trial.
Park Se-jin, Chief Executive Officer (CEO) of LigaChem Biosciences, stated that the first patient dosing of LCB02A represents a significant milestone. It marks the clinical debut of the payload diversification strategy, which combines the ConjuAll platform with a Topo1 inhibitor payload.
He added that they’re committed to rapidly advancing the clinical trials in collaboration with world-renowned cancer centers. The goal is to demonstrate LCB02A’s unique competitive edge in the CLDN18.2 ADC market through robust clinical data.
