Clinical trial NCT04823897: 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
Official title: 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
Conditions: Cancer: Recurrent and/or Metastatic Solid Tumours
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, 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.
Interventions:
description: Part 1 Dose Escalation: CCI-001 will be given intravenously starting at 1.2mg/m2 in the first cohort. The dose escalation between cohorts will depend on adverse event grading, as judged by NCI-CTCAE. Part 1 is complete when the maximum tolerated dose and the recommended expansion dose are determined.<br/>Part 2 Dose Expansion: cohorts of patients with the following tumour types will be enrolled: 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]). These patients will receive the Part 1 recommended CCI-001 dose.<br/>In Part 3 Dose Expansion: CCI-001 with Gemcitabine or Carboplatin, the same Part 2 tumour types will be treated at approved doses of gemcitabine or carboplatin, with CCI-001 below the recommended dose.
name: CCI-001
type: Drug
Study arms:
design_group_description: Part 1 Dose-Escalation: CCI-001 will be given at the starting dose to a cohort of patients with recurrent and/or metastatic solid tumours. The dose will be escalated sequentially in subsequent cohorts to determine the maximum tolerated dose, and the recommended dose for dose expansions.<br/>Part 2 CCI-001 Monotherapy Dose Expansion: patients with these tumour types will be enrolled: 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]). Patients will receive the Part 1 recommended dose.<br/>Part 3 Dose Expansion: CCI-001 with Gemcitabine or Carboplatin will enroll the same tumour types as Part 2. Treatment will be at approved doses of gemcitabine or carboplatin, with CCI-001 started at less than the recommended dose.
design_group_title: Dose Escalation and Expansion
design_group_type: Experimental
Sponsor: PharmaMatrix Holdings Ltd
Collaborators: University of Alberta
Drug name mappings:
name: CCI-001
lang: EN