Handok Submits IND for Phase 2 and 3 Trials of Biliary Tract Cancer Anticancer Drug 'HDB001A'

Handok announced on the 26th that it has submitted the global Phase 2/3 clinical trial plan (IND) for 'HDB001A' targeting cholangiocarcinoma patients to the Ministry of Food and Drug Safety.

Handok CI

This clinical trial will be conducted in the form of participation in the ongoing global Phase 2/3 trial (NCT05506943), for which the US biotech venture Compass Therapeutics has received IND approval from the US Food and Drug Administration (FDA). Handok, collaborating with Compass Therapeutics on the development of HDB001A as a treatment for cholangiocarcinoma, plans to conduct a Phase 2 clinical trial in Korea targeting cholangiocarcinoma patients to establish a foundation for expansion into a global trial. The goal is to secure efficacy and safety data of HDB001A from a large patient population, which will be utilized for future regulatory approval applications.

The global Phase 2/3 trial of HDB001A will be conducted at over 35 institutions in Korea and abroad, involving 150 patients. It will be a randomized, controlled study comparing paclitaxel monotherapy with a combination therapy of HDB001A and paclitaxel in adult patients with unresectable advanced, metastatic, or recurrent cholangiocarcinoma who have previously received one systemic chemotherapy regimen.

Currently, cholangiocarcinoma has very limited treatment options. The 5-year survival rate is less than 20%, and only 10% of cases are detected at an early stage amenable to surgical resection. Even after surgery, there is a high recurrence rate exceeding 60%. HDB001A is a next-generation anticancer agent utilizing ABL Bio’s (ABL Bio) bispecific antibody platform technology. Handok holds the rights in Korea through a license agreement with ABL Bio, while Compass Therapeutics has a technology transfer agreement with ABL Bio and holds global rights excluding Korea.

Earlier this year, results from Handok’s domestic Phase 2 clinical trial were presented at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI 2023). The objective response rate (ORR) for patients treated with the combination of HDB001A and paclitaxel was 37.5% in second- and third-line treatments. With over 12 months of follow-up, the median progression-free survival (mPFS) was 9.4 months, and the median overall survival (mOS) was 12.5 months. The company explained that the mPFS of FOLFOX-based therapy, which is currently recommended as second-line treatment for advanced cholangiocarcinoma in the US National Comprehensive Cancer Network (NCCN) guidelines, is only 4.0 months, with an overall survival of 6.2 months.

Youngjin Kim, Chairman of Handok, stated, “HDB001A is showing meaningful results in clinical trials targeting cholangiocarcinoma patients,” and added, “Through this clinical trial, we will secure additional data on Korean patients to ensure that HDB001A can become a new hope for Korean patients as a second-line treatment for cholangiocarcinoma.”