Clinical Trials Logo

Clinical Trial Summary

This is a multi-center, open-label Phase 0 Master Protocol in Australia designed to study the localized pharmacodynamics (PD) of anti-cancer therapies within the tumour microenvironment (TME) when administered intratumourally in microdose quantities via the CIVO device in patients with surface accessible solid tumours for which there is a scheduled surgical intervention. CIVO stands for Comparative In Vivo Oncology. Multiple substudies will include specified investigational agents and combinations to be evaluated.


Clinical Trial Description

CIVO is a research tool composed of a hand-held single-use sterile injector coupled with fluorescent tracking microspheres called CIVO GLO that mark the sites of drug microdose injection, enabling rapid assessment of multiple oncology drugs or drug combinations simultaneously within a patient's tumour. Tumour responses to cancer treatments are highly context-specific and often involve complex interactions between the anti-cancer therapy, genetically diverse tumour cells, and a heterogeneous TME. This complexity is rarely modeled accurately in preclinical translational models of cancer. By utilizing intratumoural microdose injections with CIVO in advance of scheduled surgical intervention, this study will evaluate anti-cancer therapies directly in patients each with their own unique tumour genomic profile, intact TME, and immune system functional status. Because the platform delivers microdose amounts of each test agent or combination directly into the patient's tumour tissue, hypotheses can be tested earlier in the drug development process. The CIVO device penetrates solid tumours and simultaneously delivers subtherapeutic microdoses of up to eight anti-cancer agents or combinations of anti-cancer agents co-injected with CIVO GLO into discrete regions of the tumour as drug columns. At the time of the planned surgical intervention (at least four hours to up to seven days after the CIVO microdose injection), the injected tumour tissue is then excised and tumour responses are assessed via histological staining of tumour cross-sections sampled perpendicular to each injection column. Co-injection with CIVO GLO enables identification of each injection site during resection as well as in tissues stained for analysis. This Phase 0 Master Protocol is aimed at distinguishing promising candidates earlier in the drug development process while also avoiding systemic toxicities associated with typical clinical exposures to these therapies. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04891718
Study type Interventional
Source Presage Biosciences
Contact
Status Withdrawn
Phase Early Phase 1
Start date September 15, 2021
Completion date June 5, 2022

See also
  Status Clinical Trial Phase
Completed NCT02648490 - An Open-label, Phase 1 Study to Determine the Maximum Tolerated Dose of HLX07,in Patients With Advanced Solid Cancers Phase 1
Recruiting NCT01226407 - Examine Maximum Tolerated Dose and Pharmacokinetic and Pharmacodynamic Profile Phase 1
Completed NCT01447732 - Phase 1 Study of CEP-37250/KHK2804 in Subjects With Advanced Solid Tumors Phase 1
Completed NCT04958226 - A Study to Assess the Effect of Capivasertib on Midazolam in Patients With Advanced Solid Tumours Phase 1
Completed NCT04121910 - A Study to Evaluate the Amount of Drug That Becomes Available in the Blood Circulation When Savolitinib is Administered Alone and in Combination With Itraconazole Phase 1
Terminated NCT01219543 - A Phase I Study of AZD1480 in Patients With Advanced Solid Malignancies and Advanced Hepatocellular Carcinoma in the Escalation Phase,Non-Small Cell Lung Cancer(NSCLC) and Non-smokers With Lung Metastasis and Gastric Cancer and Solid Tumour in the Expansion Phase. Phase 1
Completed NCT01627990 - Nivestimâ„¢ in Treatment of Malignant Diseases N/A
Terminated NCT01516645 - Phase 1 Study of KHK2898 in Subjects With Advanced Solid Tumors Phase 1
Completed NCT01489826 - A Phase 1 Study of Dexanabinol in Patients With Advanced Solid Tumours Phase 1
Unknown status NCT01046461 - Ramosetron, Aprepitant and Dexamethasone (RAD) in Solid Cancer Phase 2
Completed NCT02086721 - Phase I Clinical Study Combining L19-IL2 With SABR in Patients With Oligometastatic Solid Tumor Phase 1
Active, not recruiting NCT00467779 - Study of GDC-0973/XL518 in Patients With Solid Tumors Phase 1
Completed NCT01300468 - Study of PHA-848125AC in Adult Patients With Advanced/Metastatic Solid Tumors Phase 1