Handok said on Wednesday that it submitted an IND plan for a global phase 2/3 clinical trial of HDB001A, a biliary tract cancer drug candidate, to the Ministry of Food and Drug Safety (MFDS). 

The global phase 2/3 study of HDB001A will enroll 150 patients at more than 35 sites in Korea and overseas. It will be a randomized, controlled trial of HDB001A in combination with paclitaxel versus paclitaxel monotherapy in adult patients with unresectable advanced, metastatic, or recurrent biliary tract cancer who have received one prior systemic chemotherapy regimen.

Currently, biliary tract cancer has very limited treatment options. The five-year survival rate is less than 20 percent, and only 10 percent of cases are detected in the early stages when surgical resection is possible, with a recurrence rate of more than 60 percent even after surgery. 

However, HDB001A is a next-generation anti-cancer drug candidate utilizing ABL Bio’s bispecific antibody platform technology. Earlier this year, the results of Handok's Korean phase 2 clinical trial were presented at the American Society of Clinical Oncology Digestive Cancer Symposium (ASCO GI 2023), drawing attention as a novel treatment for advanced biliary tract cancer with high unmet need. 

The efficacy of HDB001A was evaluated in the phase 2 study, and the objective response rate (ORR) for patients receiving HDB001A in combination with paclitaxel was 37.5 percent in the second and third lines. In addition, a median progression-free survival (mPFS) of 9.4 months and a median overall survival (mOS) of 12.5 months were demonstrated at 12 months of follow-up. 

"HDB001A has shown significant results in clinical trials in patients with biliary tract cancer," said Handok Chairman and CEO Kim Young-jin. "This study will provide additional data in Korean patients to ensure that HDB001A offers new hope for Korean patients in the second-line treatment of biliary tract cancer."

Handok has also entered into a license agreement with ABL Bio, the original developer of HDB001A, to retain the rights of the drug in Korea. Meanwhile, Compass Therapeutics, with whom Handok is collaborating for the global and domestic clinical development of HDB001A, has also entered into a technology transfer agreement with ABL Bio for the global rights to HDB001A outside of Korea.