Press release
Compass Reports the Advancement of CTX-009, a Bispecific Antibody, to Phase 2a Development in Patients with Biliary Tract Cancers (BTC), and the Clearance of a Key Clinical Hurdle
Phase 2a study was initiated by Handok Pharmaceuticals in Q1 2021 in patients with Biliary Tract Cancers (cholangiocarcinoma). Enrollment in the first part
About this update from Compass Therapeutics, Inc.
[{"type":"text","content":"\n\nPhase 2a study was initiated by Handok Pharmaceuticals in Q1 2021 in patients with Biliary Tract Cancers (cholangiocarcinoma).\n\n\n\nEnrollment in the first part of the study has been completed and the criteria to advance to the second part of the study have been met.\n\n\n\nNotably, five partial responses have already been observed among the first 17 patients evaluated leading to a preliminary overall response rate of 29% (ORR=29%), and all patients evaluated have had stable disease or better with a decline in tumor burden observed in 16 of the 17 patients leading to a Clinical Benefit Rate of 100% (CBR=100%).\n\n\n\nCompass plans to submit an Investigational New Drug (IND) application to the United States Food and Drug Administration (FDA) this quarter, and subject to the IND clearance with the FDA, to initiate a Phase 2 study in Q2 2022.\n\n\n \n\n BOSTON--(BUSINESS WIRE)--\nCompass Therapeutics, Inc. (OTC:CMPX) today provided an update on the clinical development of CTX-009 (also known as ABL001), a dual anti-angiogenic bispecific antibody targeting DLL4 and VEGF-A.\n\nA Phase 2a study for CTX-009 in combination with paclitaxel was initiated by Handok Pharmaceuticals, Inc. (KOSDAQ: 002390) in Q1 2021 in patients with BTC and the enrollment in the first part of the study has been completed. The study has been enrolling patients who have unresectable advanced, metastatic, or relapsed BTC’s who have received one or two prior systemic therapies. The Phase 2a design was informed by the CTX-009 Phase 1b study, where CTX-009 in combination with either paclitaxel or irinotecan led to an overall response rate of 23.5% and a clinical benefit rate of 76.5%, including two confirmed and durable partial responses among four patients with advanced cholangiocarcinoma (clinicaltrials.gov Identifier: NCT04492033).\n\nThe Phase 2a study utilizes a Simon Two-Stage adaptive design where the criteria to advance to the second stage of the study is three or more partial responses observed in 21 patients. So far, there have been five partial responses observed among the first 17 patients evaluated, which is an overall response rate of 29%, and accordingly, the criteria to advance to the second part of the study has been met. In the second part of the Phase 2a study, 45 additional patients will be enrolled. The preliminary adverse event profile ...