A Study of CCI-001 in Patients With Recurrent and/or Metastatic Solid Tumours
Status:
Recruiting
Trial end date:
2023-05-01
Target enrollment:
Participant gender:
Summary
CCI-001 is a novel colchicine derivative that is being developed by PharmaMatrix Holdings
Ltd. (PharmaMatrix). The drug binds to tubulin, a component of the microtubule polymers which
are required for a wide range of cellular processes, perhaps most importantly, cell division
and mitosis. CCI-001 has been shown to bind more strongly to β-III tubulin, a tubulin subtype
which is overexpressed in many cancers.
This trial is being undertaken as a first-in-human, Phase I trial in patients with recurrent
and/or metastatic solid tumours. Primary Objectives are to examine the compound's safety
profile, to determine the recommended dose, and to determine pharmacokinetic parameters and
metabolism.
Secondary Objectives are to evaluate the clinical response rate and survival. Expansion
cohorts in in tumour types known to be sensitive to other approved agents with similar
mechanism of action will be treated at the recommended dose: transitional cell bladder
cancer, pancreaticobiliary adenocarcinomas, gynecologic cancers (ovarian, cervical,
endometrial), and lung adenocarcinoma.