What this Trial Is About

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, and to determine the recommended dose. Secondary Objectives are to determine the compound's pharmacokinetic parameters and to evaluate the clinical response rate (objective response rate and progression-free survival). Expansion cohorts (Parts 2 and 3) will enroll patients with the following tumour types: gynecologic cancers (ovarian \[including fallopian tube and primary peritoneal\], cervical, endometrial, vulvar), pancreaticobiliary adenocarcinomas and others (lung adenocarcinoma, head and neck adenocarcinomas, transitional cell bladder cancer, and upper GI tumours \[including esophageal, gastroesophageal junction and stomach\]). Part 2 Expansion cohorts will be treated at the recommended dose. Part 3 Expansion cohorts will be treated at a CCI-001 dose lower than the recommended dose in combination with either gemcitabine or cisplatin.

A Phase I Open-Label, Single-Arm, Dose-Escalation Clinical and Pharmacology Study of CCI-001 as Monotherapy and in Combination With Standard Chemotherapy in Patients With Recurrent and/or Metastatic Solid Tumours