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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 (May 2026). This Phase 1/2 trial studies IMP9064 for solid tumor.

Phase 1/2RecruitingImpact Therapeutics, Inc.NCT05269316Data as of May 2026

Treatment: IMP9064This 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

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Extracted eligibility criteria

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 →

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