OncoMatch/Clinical Trials/NCT05269316
Study to Evaluate IMP9064 as a Monotherapy or in Combination in Patients With Advanced Solid Tumors
Is NCT05269316 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1/2 trial studies IMP9064 for solid tumor.
Treatment: IMP9064 — 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
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Tumor Agnostic
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: standard-of-care therapy — refractory or intolerant, or no standard treatment exists
AST refractory to or intolerant of available standard-of-care therapy or for which no standard treatment exists
Cannot have received: systemic cancer therapy
Any investigational or approved systemic cancer therapy (including chemotherapy, immunotherapy, hormonal therapy and herbal/alternative therapies with anti-cancer indications, or targeted therapy) administered within 28 days or 5 half-lives, whichever is shorter, before the first dose of study drug
Cannot have received: treatment targeting the ATR/CHK1 pathway
Any treatment targeting the ATR/CHK1 pathway
Cannot have received: live virus or bacterial vaccine
Exception: non-live COVID-19 vaccines allowed
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)
Cannot have received: investigational product
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
Cannot have received: investigational device
An investigational device within 28 days prior to the first dose of study drug
Cannot have received: proton pump inhibitors or potassium competitive acid blockers
Patients who may need continuous treatment with proton pump inhibitors or potassium competitive acid blockers during the study period
Cannot have received: major surgery
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
Lab requirements
Cardiac function
No clinically significant cardiovascular condition (e.g., NYHA Class > 2 heart failure, unstable angina, recent MI or arrhythmia within 6 months unless stably controlled); no abnormal ECG that is clinically meaningful (QTcF > 470 msec for females, > 450 msec for males, pacemaker, or congenital long QT syndrome)
Clinically significant cardiovascular condition, including: History of congestive heart failure (NYHA Class > 2), unstable angina, new-onset angina or MI within 6 months, new onset of arrhythmia within 6 months and requiring treatment/intervention unless stably controlled. 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).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Hackensack University Medical Center PARTNER · Hackensack, New Jersey
- Mount Sinai · New York, New York
- Greenville Hospital System University Medical Center (ITOR) · Greenville, South Carolina
- Mary Crowley Cancer Research Centers · Dallas, Texas
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT05269316 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior systemic cancer therapy, treatment targeting the ATR/CHK1 pathway, live virus or bacterial vaccine disqualifies patients from enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify