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Study of IMP9064 for Advanced Solid Tumors

This study is testing a new drug called IMP9064, either by itself or with another drug called Senaparib, for people with advanced solid tumors. IMP9064 is designed to stop cancer cells from repairing their DNA, which could make them die. The main goals are to see how safe IMP9064 is and to find the highest dose that can be given without causing too many side effects. You might be able to join if you are 18 years or older and have an advanced solid tumor. The study plans to enroll about 61 people. The current recruitment status is unclear.

Study design
This is an open-label study, meaning you and your doctors will know which treatment you are receiving. It is a Phase 1/2 study, which means it's an early-stage trial looking at safety and effectiveness. It plans to enroll about 61 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will measure safety and the maximum tolerable dose for 11 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05269316

Study to Evaluate IMP9064 as a Monotherapy or in Combination in Patients With Advanced Solid Tumors

Recruiting
PHASE1Ages 18+InterventionalTreatment
Impact Therapeutics, Inc.
~61 participants
Updated 2025-04-01 on ClinicalTrials.gov
What's tested:IMP9064

At a glance

Recruiting sites
1 of 8 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of adverse events (Safety and Tolerability)
Measured over 11 months
+1 more outcome measured

Conditions

Solid Tumor
Advanced Solid Tumor

Explore related trials

Solid Neoplasm

NCT05269316

Where you'd take part

This study runs at 8 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, Chinano site contact published

    Recruiting

  • Blacktown Hospital

    Blacktown, New South Wales, Australiano site contact published

    Completed

  • Greenville Hospital System University Medical Center (ITOR)

    Greenville, South Carolinano site contact published

    Completed

  • Hackensack University Medical Center PARTNER

    Hackensack, New Jerseyno site contact published

    Completed

  • Linear Clinical Research Limited

    Nedlands, Australiano site contact published

    Completed

  • Mary Crowley Cancer Research Centers

    Dallas, Texasno site contact published

    Completed

  • Mount Sinai

    New York, New Yorkno site contact published

    Completed

  • National Taiwan University Hospital

    Taipei, Taiwanno site contact published

    Completed

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Xiangna Chen
[email protected]
+86-021-68411121
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Exclusion

History of congestive heart failure (New York Heart Association \[NYHA\] Class \> 2)
History of unstable angina
New-onset angina or myocardial infarction within the 6 months prior to the first dose of study drug
New onset of atrial fibrillation, supraventricular arrhythmia, or ventricular arrhythmia within the 6 months prior to the first dose of study drug and requiring treatment or intervention. History of atrial fibrillation, supraventricular arrhythmia, or ventricular arrhythmia will be allowed provided the condition is stably controlled. 6. History or presence of an abnormal ECG that, in the Investigator's opinion, is clinically meaningful (including QTcF \> 470 msec for females, QTcF \> 450 msec for males by Fridericia formula at screening, pacemaker installation or previous diagnosis of congenital long QT syndrome). 7. Patients who have undergone a major surgery or have undergone a radical radiotherapy within 28 days prior to the first dose of study drug or have undergone a palliative radiotherapy within 14 days prior to the first dose of study drug, or have used a radioactive drug (Strontium, Samarium, etc.) within 56 days prior to first dose of study drug. 8. Patients with infections, including:
An uncontrolled acute infection, or an active infection requiring systemic treatment, or patients who have received systemic antibiotics within 14 days prior to the first dose of the study drug; prophylaxis use of systemic antibiotics treatment for upper tract infection is allowed as long as there is no violation with the requirement of concomitant medications.
A known history of human immunodeficiency virus (HIV) infection and/or acquired immunodeficiency syndrome or positive HIV testing should undergo CD4+ T-cell test during the screening period. Patients with CD4+ T-cell counts \< 350 cells/μL are ineligible for enrolment as well as patients with unknown HIV infection status who are unwilling to undergo HIV testing.
A known active hepatitis B or C. To be included in the study, patients with hepatitis B virus surface antigen (HBsAg) or hepatitis C virus (HCV) antibody positive test results during screening must be further tested for hepatitis B virus (HBV) DNA titer (excluding patients with a DNA titer of more than 2500 copies \[cps\]/mL or 500 IU/mL) and HCV ribonucleic acid (RNA) (excluding patients with an HCV RNA concentration exceeding the lower detection limit of the assay) to exclude active hepatitis B or hepatitis C infection requiring treatment. Hepatitis B virus carriers, patients with stable hepatitis B infection after drug treatment (DNA titer not exceeding 2500 copies \[cps\]/mL or 500 IU/mL) and hepatitis C infected patients who received treatment and achieved sustained virologic response for at least 12 weeks can be enrolled. Note: If the lower detection limit of the HBV DNA assay is higher than 2500 copies \[cps\]/mL or 500 IU/mL, the patients with an HBV DNA assay result lower than the lower detection limit of the assay can be enrolled.
Active tuberculosis. 9. Positive test result for severe acute respiratory syndrome-related coronavirus (SARS-CoV-2) test. SARS-CoV-2 test is mandatory during screening for patients who have exposure to suspected, probable, or confirmed cases of SARS-CoV-2 infection within 14 days, via a validated test per local guidance; the result should be available within 4 days prior to the first dose of study drug. 10. Any other medical (e.g., Child-Pugh class B or C, pulmonary, metabolic, congenital, endocrinal or CNS disease, etc.), psychiatric, or social condition deemed by the Investigator to be likely to interfere with a patient's rights, safety, welfare or ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results. 11. Receipt of:
Any treatment targeting the ATR/CHK1 pathway.
Live virus or bacterial vaccine within 28 days prior to the first dose of study drug and whilst the patient is receiving study drug. Patients who require COVID-19 vaccination whilst on study drug should receive a non-live vaccine (e.g., one based on messenger RNA (mRNA) or fully inactivated/genetically modified viruses incapable of replication) (see Section 6.8.1). 12. Participation in another clinical study with an investigational product administered in the last 28 days or 5 half-lives (whichever is shorter) prior to the first administration of study drug. 13. An investigational device within 28 days prior to the first dose of study drug. 14. Patients who may need continuous treatment with proton pump inhibitors or potassium competitive acid blockers during the study period. 15. Patients who have other malignancies requiring treatment within 2 years prior to the first dose of study drug will be excluded, except for radically treated locally curable basal or squamous cell skin cancer and other malignancies that have been treated with no relapse within 2 years. Presence of other active invasive cancers will be excluded for Part 2. 16. Patients who are unable to swallow oral medications. 17. Patients who have gastrointestinal illnesses that may affect the absorption of oral medications. 18. Patients with a previously documented diagnosis of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML), or patients who have received transplantation including patients with previous allogeneic bone marrow transplant. 19. Patients known to have a history of alcoholism or drug abuse.

What this trial measures

  • Incidence of adverse events (Safety and Tolerability)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 Dose11 months

    Maximum Tolerable Dose (if any)/Recommended Phase 2 Dose of IMP9064 monotherapy