NCT05269316 · Impact Therapeutics, Inc.
Study to Evaluate IMP9064 as a Monotherapy or in Combination in Patients With Advanced Solid Tumors
What this study is about
This is a Phase 1/2, conducted at multiple hospitals, where both patients and doctors know the treatment given study to evaluate the safety and effectiveness of IMP9064 as treatment given alone or in combination with PARP inhibitor Senaparib in patients with advanced solid tumors
View original scientific description
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
Interventions
DRUG
IMP9064
IMP9064 Monotherapy administered for 21 days
Primary outcome measures
Incidence of adverse events (Safety and Tolerability)
Time frame: 11 months
Safety and tolerability as determined by the incidence of adverse events (AEs), including severe AEs and serious AEs (SAEs)
To determine the Maximum Tolerable Dose
Time frame: 11 months
Maximum Tolerable Dose (if any)/Recommended Phase 2 Dose of IMP9064 monotherapy
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 (Part 1) at screening. 5. Provision of tumor tissue samples. 6. Life expectancy ≥ 12 weeks (according to Investigator's judgement). 7. Female patients should meet at least 1 of the following criteria before they can participate in the study: 1. Females who have no childbearing potential (i.e. physiologically incapable of pregnancy
Where
- Hackensack, New Jersey
- New York, New York
- Greenville, South Carolina
- Dallas, Texas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 1, 2025 · Source of record for eligibility and locations