drugset / Trial / NCT07684170

Study of CTX-471 in Patients With Neural Cell Adhesion Molecule (NCAM) Positive Neuroendocrine Neoplasms

NCT07684170

Phase 2 Not yet recruiting 58 enrolled Compass Therapeutics
RandomizedParallel-groupOpen-labelTreatment

Summary

This study will enroll patients with central lab confirmed NCAM (CD56 IHC) positive metastatic neuroendocrine neoplasms that have progressed after standard of care treatment. CTX-471 to be administered as an intravenous (IV) infusion at either 0.3 mg/kg or 0.6 mg/kg every 2 weeks until disease progression or unacceptable toxicity. The study will be conducted in two stages. In Stage 1, 18 patients will be accrued for each dose level. If there are less than 2 objective responses in these 18 patients at either dose level, the dose level will be stopped. Otherwise, an additional 22 patients will be accrued in Stage 2 with 11 patients for each dose level.

Timeline

Start
2026-09
Primary completion
2028-09
Completion
2029-09

Drugs

EvaluationDrugModalityDoseRoute
Subject CTX-471 Unknown 0.3 mg/kg Intravenous
Subject CTX-471 Unknown 0.6 mg/kg Intravenous