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New treatment option for Solid Tumor
Official title Study to Evaluate IMP9064 as a Monotherapy or in Combination in Patients With Advanced Solid Tumors
ClinicalTrials.gov ID: NCT05269316
What this study is testing
What is IMP9064?
IMP9064 is an investigational medicine, being studied as a potential treatment for solid tumor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Must voluntarily participate in the study and be willing and able to provide signed informed consent which includes compliance with the requirements...
- Male or female patients with histologically or cytologically confirmed AST refractory to or intolerant of available standard-of-care therapy or for...
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 (Part 1) at screening.
- Provision of tumor tissue samples.
You likely can't join if
- Known history of hypersensitivity to any components of the study drug.
- Any investigational or approved systemic cancer therapy (including chemotherapy, immunotherapy, hormonal therapy and herbal/alternative therapies...
- Any previous treatment-related toxicities have not recovered, i.e. to ≤ Grade 1, as evaluated by NCI-CTCAE version 5.0 or baseline, except alopecia...
- Primary tumor in CNS, or active or untreated CNS metastases and/or carcinomatous meningitis. Patients with previously treated brain metastases may...
- Clinically significant cardiovascular condition, including:
- History of congestive heart failure (New York Heart Association [NYHA] Class \> 2)
See the full eligibility criteria
Who can join
- 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).
- 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.
- 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.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 (Part 1) at screening.
- Provision of tumor tissue samples.
- Life expectancy ≥ 12 weeks (according to Investigator's judgement).
- Female patients should meet at least 1 of the following criteria before they can participate in the study:
- Females who have no childbearing potential (i.e. physiologically incapable of pregnancy), including those who have undergone hysterectomy, bilateral oophorectomy, or bilateral salpingectomy.
- Post-menopausal (total cessation of menses for ≥ 1 year).
- Females of childbearing potential should have a negative serum pregnancy test during the screening period (within 7 days prior to the first dose of the study drug), should not be in lactation, and should be willing to...
- Male patients are eligible to participate in the study if they have undergone vasectomy or agree to use a highly effective method of contraception and refrain from donating sperms from study entry up to 6 months after...
- Willing and able to comply with study visits and study-related procedures.
- For optional PD analysis in Part 1, patients should be willing provide hairs plucked from eyebrows pre and post treatment with IMP9064 and fresh tumor biopsies (if deemed necessary by SMC) pre and post treatment with...
What rules you out
- Known history of hypersensitivity to any components of the study drug.
- 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...
- Any previous treatment-related toxicities have not recovered, i.e. to ≤ Grade 1, as evaluated by NCI-CTCAE version 5.0 or baseline, except alopecia and anemia. Patients with chronic Grade 2 toxicities which are well...
- Primary tumor in CNS, or active or untreated CNS metastases and/or carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are clinically stable for at least 28 days and...
- Clinically significant cardiovascular condition, including:
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- Active tuberculosis.
- 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...
- 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...
- 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...
- 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.
- An investigational device within 28 days prior to the first dose of study drug.
- Patients who may need continuous treatment with proton pump inhibitors or potassium competitive acid blockers during the study period.
- 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...
- Patients who are unable to swallow oral medications.
- Patients who have gastrointestinal illnesses that may affect the absorption of oral medications.
- 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...
- Patients known to have a history of alcoholism or drug abuse.
The study team makes the final eligibility decision.
Where it's taking place
- Hackensack, New Jersey, United States
- New York, New York, United States
- Greenville, South Carolina, United States
- Dallas, Texas, United States
- Blacktown, New South Wales, Australia
- Nedlands, Australia
- Beijing, Beijing Municipality, China
- Taipei, Taiwan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hackensack, New Jersey, United States; New York, New York, United States; Greenville, South Carolina, United States; Dallas, Texas, United States; Blacktown, New South Wales, Australia; Nedlands, Australia and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.