Share
Save
Study to Evaluate IMP9064 as a Monotherapy or in Combination in Patients With Advanced Solid Tumors
This is a Phase 1/2, multicenter, open-label study to evaluate the safety and efficacy of IMP9064 as monotherapy or in combination with PARP inhibitor Senaparib in patients with advanced solid tumors.
Study details:
IMP9064 is an investigational therapeutic protein that may prevent repair of DNA damage in tumor cell. IMP9064 acts as inhibitor (blocker)of the proteins ataxia-telangiectasia and Rad3-related kinase (ATR) which are important in cancer cell DNA repair. If cancer cells cannot repair damage to their DNA, then there is a high possibility that cancer cells will not survive.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2022-02-11
Primary completion: 2025-07-31
Study completion finish: 2025-07-31
Study type
TREATMENT
Phase
PHASE1
Trial ID
NCT05269316
Intervention or treatment
DRUG: IMP9064
Conditions
- • Solid Tumor
- • Advanced Solid Tumor
Find a site
Closest Location:
Blacktown Hospital
Research sites nearby
Select from list below to view details:
Blacktown Hospital
Blacktown, New South Wales, Australia
Linear Clinical Research Limited
Nedlands, Not Specified, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: IMP9064 Monotherapy
| DRUG: IMP9064
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Incidence of adverse events (Safety and Tolerability) | Safety and tolerability as determined by the incidence of adverse events (AEs), including severe AEs and serious AEs (SAEs) | 11 months |
To determine the Maximum Tolerable Dose | Maximum Tolerable Dose (if any)/Recommended Phase 2 Dose of IMP9064 monotherapy | 11 months |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
To determine Maximum concentration (Cmax) | The plasma concentration data of IMP9064 from this study will be analyzed using a non-linear mixed effects modeling (NONMEM) | 11 months |
To determine area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC0-t) | The plasma concentration data of IMP9064 from this study will be analyzed using a non-linear mixed effects modeling (NONMEM) | 11 months |
To assess Overall response rate (ORR) | Anti-tumor activity of IMP9064 monotherapy assessed as Overall response rate (ORR) according to RECIST version 1.1 in AST patients | 11 months |
To assess Disease control rate (DCR) | Anti-tumor activity of IMP9064 monotherapy assessed as Disease control rate (DCR) according to RECIST version 1.1 in AST patients | 11 months |
To assess Duration of response(DOR) | Anti-tumor activity of IMP9064 monotherapy assessed as Duration of response(DOR) according to RECIST version 1.1 in AST patients | 11 months |
To assess Progression free survival(PFS) | Anti-tumor activity of IMP9064 monotherapy assessed as Progression free survival(PFS) according to RECIST version 1.1 in AST patients | 11 months |
To assess Overall survival(OS) | Anti-tumor activity of IMP9064 monotherapy assessed as Overall survival(OS) according to RECIST version 1.1 in AST patients | 11 months |
To assess QT interval | To assess correlation between plasma concentrations of IMP9064 and QT interval | 11 months |
Frequently Asked Questions
Please note: some questions and answers are submitted by anonymous patients or using AI, and have not been verified by Clinrol
No questions submitted. Be the first to ask a question!