COMPANION-002 A clinical trial of investigational drug CTX-009 plus paclitaxel vs paclitaxel in second line advanced BTC

Future Oncol. 2024;20(30):2241-2248. doi: 10.1080/14796694.2024.2351351. Epub 2024 Jun 4.

Abstract

Treatment options for patients with biliary tract cancer are limited, and the prognosis is poor. CTX-009, a novel bispecific antibody targeting both DLL4 and VEGF-A, has demonstrated antitumor activity in patients with advanced cancers as both a monotherapy and in combination with chemotherapy. In a phase II study of patients with advanced biliary tract cancer who had received one or two prior therapies, CTX-009 with paclitaxel demonstrated a 37.5% overall response rate (ORR). Described here is the design of and rationale for COMPANION-002, a randomized phase II/III study, which will evaluate the safety and efficacy of CTX-009 in combination with paclitaxel versus paclitaxel alone as second-line treatment for patients with advanced biliary tract cancer. The primary end point is ORR, and crossover is allowed.Clinical Trial Registration: NCT05506943 (ClinicalTrials.gov).

Keywords: CTX-009; DLL4; Paclitaxel; VEGF; anti-angiogenesis; biliary tract cancer; cholangiocarcinoma; clinical trial.

Plain language summary

Looking for new options for patients with advanced biliary tract cancer? Explore COMPANION-002, Compass Therapeutics’ phase II/III study of CTX-009 + paclitaxel as a second line treatment.#CMPX #biotech #healthcare #rarecancer.

Publication types

  • Clinical Trial Protocol
  • Randomized Controlled Trial
  • Clinical Trial, Phase II

MeSH terms

  • Adult
  • Aged
  • Antibodies, Bispecific / administration & dosage
  • Antibodies, Bispecific / adverse effects
  • Antibodies, Bispecific / therapeutic use
  • Antineoplastic Combined Chemotherapy Protocols* / adverse effects
  • Antineoplastic Combined Chemotherapy Protocols* / therapeutic use
  • Biliary Tract Neoplasms* / drug therapy
  • Biliary Tract Neoplasms* / pathology
  • Female
  • Humans
  • Male
  • Middle Aged
  • Paclitaxel* / administration & dosage
  • Paclitaxel* / adverse effects
  • Paclitaxel* / therapeutic use
  • Treatment Outcome
  • Vascular Endothelial Growth Factor A / antagonists & inhibitors

Substances

  • Paclitaxel
  • Antibodies, Bispecific
  • Vascular Endothelial Growth Factor A

Associated data

  • ClinicalTrials.gov/NCT05506943