A First-in-human, Phase 1/2, Open-label, Multi-center, Dose-escalation and Dose-expansion Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of the ATR Inhibitor IMP9064 Monotherapy and in Combination With PARP Inhibitor Senaparib in Patients With Advanced Solid Tumors
Impact Therapeutics, Inc.
Summary
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
Description
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Patients ≥ 18 years of age on the day of signing informed consent form (ICF) (at the time of screening for Part 1 and Part 2C and pre-screening for Part 2A and Part 2B). 2. Must voluntarily participate in the study and be willing and able to provide signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol. 3. Male or female patients with histologically or cytologically confirmed AST refractory to or intolerant of available standard-of-care therapy or for which no standard treatment exists. 4. Eastern…
Interventions
- DrugIMP9064
IMP9064 Monotherapy administered for 21 days
Locations (8)
- Hackensack University Medical Center PARTNERHackensack, New Jersey
- Mount SinaiNew York, New York
- Greenville Hospital System University Medical Center (ITOR)Greenville, South Carolina
- Mary Crowley Cancer Research CentersDallas, Texas
- Blacktown HospitalBlacktown, New South Wales
- Linear Clinical Research LimitedNedlands