CKD-703 / Chong Kun Dang - LARVOL DELTA

A First-in-Human Study of CKD-703 in Advanced Solid Tumors and Non-Small Cell Lung Cancer (clinicaltrials.gov) - P1/2 | N=140 | Recruiting | Sponsor: Chong Kun Dang Pharmaceutical | Not yet recruiting ➔ Recruiting

Enrollment open • First-in-human • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • MET

South Korea’s CKD Pharmaceutical announced on April 20 that it has enrolled the first patient in the United States for a global clinical trial of its antibody-drug conjugate (ADC) cancer therapy candidate, CKD-703 (Korea News Plus) - "The trial targets patients with non-small cell lung cancer and other solid tumors and will be conducted at around 12 institutions across South Korea and the United States. Among them is the MD Anderson Cancer Center. The first patient was enrolled at the Gabrail Cancer Center in Ohio....The drug received approval from the U.S. Food and Drug Administration in July last year to proceed with trials, followed by approval of the investigational new drug application from South Korea’s Ministry of Food and Drug Safety this February. CKD Pharmaceutical plans to expand the clinical trial into additional regions, including Europe, as development progresses."

Trial status • Non Small Cell Lung Cancer

CKD-703, a novel antibody-drug conjugate targeting cMET with an enhanced therapeutic index in solid tumors (AACR 2024) - "By strategically addressing challenges associated with moderate cMET expression levels, CKD-703 emerges as a promising therapeutic candidate, aiming to broaden the therapeutic index in cMET-overexpressing solid tumors. This study highlights the importance of tailored approaches to diverse patient populations in advancing the development of CKD-703 in the pursuit of precision cancer therapies."

ADC • Late-breaking abstract • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A First-in-Human Study of CKD-703 in Advanced Solid Tumors and Non-Small Cell Lung Cancer (clinicaltrials.gov) - P1/2 | N=140 | Not yet recruiting | Sponsor: Chong Kun Dang Pharmaceutical

First-in-human • New P1/2 trial • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • MET

Chong Kun Dang Receives FDA Approval for Clinical Trial of ADC-based Anticancer Drug ‘CKD-703’ (Business Korea) - "Chong Kun Dang announced on July 25 that it has received approval from the U.S. Food and Drug Administration (FDA) for the clinical trial plan to conduct Phase 1/2a trials of ‘CKD-703’, its self-developed antibody-drug conjugate (ADC) based anticancer drug...With this clinical approval, Chong Kun Dang plans to evaluate the safety and maximum tolerated dose of CKD-703 through stepwise dose escalation in non-small cell lung cancer and solid tumor patients in the United States. The company will also derive the optimal dose through proof of concept (POC). It has been decided to comprehensively confirm pharmacokinetics, immunogenicity, and initial efficacy."

New P1/2 trial • Solid Tumor

CKD Pharm’s c-Met-targeting CKD-703 induces cancer cell death in solid tumors (Bioworld) - "Chong Kun Dang Pharm (CKD Pharm) has presented data on their c-Met-targeting antibody-drug conjugate (ADC) CKD-703 for the treatment of solid tumors. CKD-703 was designed based on site-specific conjugation, with a stable and homogeneous drug-antibody ratio profile."

Preclinical • Oncology • Solid Tumor