Handok's Partner Compass Therapeutics Completes Patient Enrollment for Phase 2/3 Clinical Trial of Bile Duct Cancer Treatment HDB001A (CTX-009)

  • 2024.08.09
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Handok's Partner Compass Therapeutics Completes Patient Enrollment for Phase 2/3 Clinical Trial of Bile Duct Cancer Treatment HDB001A (CTX-009)

Handok's partner, Compass Therapeutics, announced on August 6 (U.S. time) that they have completed the planned enrollment of 150 patients for the Phase 2/3 clinical trial of HDB001A (CTX-009) targeting patients with metastatic or recurrent bile duct cancer.

Handok and Compass Therapeutics have been collaborating on the development of HDB001A (CTX-009), an innovative bispecific antibody drug with high potential as a bile duct cancer treatment. Based on the Phase 2 clinical trial conducted by Handok in Korea, Compass Therapeutics has been conducting the Phase 2/3 trial COMPANION-002 in the United States.

COMPANION-002 involves 150 patients with metastatic or recurrent bile duct cancer and compares the combination therapy of HDB001A (CTX-009) and paclitaxel with paclitaxel monotherapy. Although the trial was initially planned to be conducted in both the United States and Korea, the patient enrollment in the United States has been completed, and thus, the patient recruitment in Korea, which was to be led by Handok, will not proceed. Handok plans to use the results of COMPANION-002 as clinical data for the domestic approval of HDB001A (CTX-009).

Additionally, Compass Therapeutics has received approval for a new investigator-sponsored trial to use HDB001A (CTX-009) as a first-line treatment for bile duct cancer. This trial will be conducted at MD Anderson Cancer Center in Texas, with HDB001A (CTX-009) being added to the first-line therapy regimen of gemcitabine, cisplatin, and durvalumab.

Dr. Thomas Schuetz, co-founder, vice-chairman of the board, and CEO of Compass Therapeutics, stated, "We are very pleased to have the opportunity to expand HDB001A (CTX-009) as a first-line treatment in collaboration with researchers at MD Anderson, following the completion of patient enrollment for the COMPANION-002 trial as a second-line treatment."

Handok Chairman Kim YoungJin commented, "The rapid patient enrollment for COMPANION-002 brings us one step closer to securing more data on bile duct cancer patients, following the Phase 2 trial led by Handok in Korea. We hope to introduce a new and innovative treatment for bile duct cancer, an area with limited treatment options, to the domestic market as soon as possible."

Meanwhile, Handok holds the rights to HDB001A, initially developed as ABL001, through a licensing agreement with ABL Bio. Compass Therapeutics holds the global rights to CTX-009, excluding Korea.
 
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