Compass Therapeutics has initiated the first patient dosing in an Investigator Sponsored Trial (IST) at MD Anderson Cancer Center. This trial evaluates tovecimig (CTX-009), a DLL4 x VEGF-A bispecific antibody, as a first-line treatment for biliary tract cancer (BTC). This follows positive top-line results from Compass Therapeutics’ ongoing Phase 2/3 trial of tovecimig in second-line BTC treatment.
This IST is crucial because it explores tovecimig’s potential in the first-line setting for BTC, a cancer with limited treatment options. The trial’s outcome could significantly impact treatment paradigms for BTC, particularly if the combination therapy shows improved efficacy and safety compared to the current standard of care. The prior positive Phase 2/3 data strengthens the rationale for this first-line study and suggests potential benefits for patients earlier in their disease course.
The open-label trial will evaluate tovecimig in combination with gemcitabine, cisplatin, and durvalumab in approximately 50 patients with unresectable or metastatic BTC. It includes a safety run-in phase followed by an expansion phase. The primary objectives are to assess 6-month progression-free survival, tolerability, safety, and the maximum tolerated dose of tovecimig in this combination. Secondary objectives include overall response rate, duration of response, progression-free survival, and overall survival.
Positive results from this IST could position tovecimig as a cornerstone therapy in first-line BTC treatment, significantly expanding its market potential. This trial, along with the ongoing Phase 2/3 study, may lead to a substantial shift in the BTC treatment landscape and offer new hope for patients with this challenging cancer. Further, the data generated will provide critical insights into the efficacy and safety of combining tovecimig with existing standard-of-care therapies.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
