Actively Recruiting
Study to Evaluate IMP9064 as a Monotherapy or in Combination in Patients With Advanced Solid Tumors
Led by Impact Therapeutics, Inc. · Updated on 2025-04-01
61
Participants Needed
8
Research Sites
254 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Study to Evaluate IMP9064 as a Monotherapy or in Combination in Patients With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients 18 years of age or older at consent
- Willing and able to provide signed informed consent and comply with study requirements
- Male or female patients with confirmed advanced solid tumor refractory or intolerant to standard therapies or with no standard treatment
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 at screening
- Provision of tumor tissue samples
- Life expectancy of at least 12 weeks
- Female patients must be post-menopausal, have no childbearing potential, or have a negative pregnancy test and agree to use effective contraception
- Male patients must have undergone vasectomy or agree to use effective contraception during and for 6 months after treatment
- Willing and able to comply with study visits and procedures
- Willing to provide optional hair samples and tumor biopsies for pharmacodynamic analysis (Part 1)
You will not qualify if you...
- Known allergy to any components of the study drug
- Received systemic cancer therapy or investigational treatment within 28 days or 5 half-lives before first dose
- Unresolved previous treatment-related toxicities above Grade 1 (except alopecia and anemia)
- Primary tumor in central nervous system or active/untreated brain metastases, except stable treated brain metastases
- Significant cardiovascular conditions including recent heart failure, angina, or arrhythmias
- Abnormal ECG findings considered clinically meaningful
- Major surgery or radical radiotherapy within 28 days, palliative radiotherapy within 14 days, or radioactive drug use within 56 days prior to first dose
- Active infections or recent antibiotic use for active infection
- Known HIV infection with low CD4+ count or unwillingness to test
- Active hepatitis B or C infections needing treatment
- Active tuberculosis
- Positive SARS-CoV-2 test or recent exposure
- Medical, psychiatric, or social conditions interfering with study participation or safety
- Prior treatment targeting ATR/CHK1 pathway
- Live virus or bacterial vaccination within 28 days prior to first dose
- Participation in another investigational study within 28 days or 5 half-lives
- Use of investigational device within 28 days
- Need for continuous proton pump inhibitors or potassium competitive acid blockers during study
- Other malignancies requiring treatment within 2 years, except certain skin cancers and stable malignancies
- Unable to swallow oral medications
- Gastrointestinal conditions affecting oral drug absorption
- History of myelodysplastic syndrome or acute myeloid leukemia
- History of alcoholism or drug abuse
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
Hackensack University Medical Center PARTNER
Hackensack, New Jersey, United States, 07601
Completed
2
Mount Sinai
New York, New York, United States, 10029
Completed
3
Greenville Hospital System University Medical Center (ITOR)
Greenville, South Carolina, United States, 29605
Completed
4
Mary Crowley Cancer Research Centers
Dallas, Texas, United States, 75251
Completed
5
Blacktown Hospital
Blacktown, New South Wales, Australia, 2148
Completed
6
Linear Clinical Research Limited
Nedlands, Australia, 6009
Completed
7
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
8
National Taiwan University Hospital
Taipei, Taiwan, 10002
Completed
Research Team
X
Xiangna Chen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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