Study to Evaluate IMP9064 as a Monotherapy or in Combination in Patients With Advanced Solid Tumors
- Conditions
- Solid TumorAdvanced Solid Tumor
- Registration Number
- NCT05269316
- Lead Sponsor
- Impact Therapeutics, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> 1. Patients = 18 years of age on the day of signing informed consent form (ICF) (at the<br> time of screening for Part 1 and Part 2C and pre-screening for Part 2A and Part 2B).<br><br> 2. Must voluntarily participate in the study and be willing and able to provide signed<br> informed consent which includes compliance with the requirements and restrictions<br> listed in the ICF and in this protocol.<br><br> 3. Male or female patients with histologically or cytologically confirmed AST<br> refractory to or intolerant of available standard-of-care therapy or for which no<br> standard treatment exists.<br><br> 4. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 (Part 1) at<br> screening.<br><br> 5. Provision of tumor tissue samples.<br><br> 6. Life expectancy = 12 weeks (according to Investigator's judgement).<br><br> 7. Female patients should meet at least 1 of the following criteria before they can<br> participate in the study:<br><br> 1. Females who have no childbearing potential (i.e. physiologically incapable of<br> pregnancy), including those who have undergone hysterectomy, bilateral<br> oophorectomy, or bilateral salpingectomy.<br><br> 2. Post-menopausal (total cessation of menses for = 1 year).<br><br> 3. Females of childbearing potential should have a negative serum pregnancy test<br> during the screening period (within 7 days prior to the first dose of the study<br> drug), should not be in lactation, and should be willing to practice a highly<br> effective contraceptive method throughout the study period (from study entry up<br> to 6 months after the last dose of the study drug). A highly effective method<br> of contraception is defined as one that results in a low failure rate, i.e.,<br> less than 1% per year, when used consistently and correctly (See Appendix 4,<br> Section 11.4).<br><br> 8. Male patients are eligible to participate in the study if they have undergone<br> vasectomy or agree to use a highly effective method of contraception and refrain<br> from donating sperms from study entry up to 6 months after the last dose of the<br> study drug.<br><br> 9. Willing and able to comply with study visits and study-related procedures.<br><br> 10. For optional PD analysis in Part 1, patients should be willing provide hairs plucked<br> from eyebrows pre and post treatment with IMP9064 and fresh tumor biopsies (if<br> deemed necessary by SMC) pre and post treatment with IMP9064.<br><br>Exclusion Criteria:<br><br> 1. Known history of hypersensitivity to any components of the study drug.<br><br> 2. Any investigational or approved systemic cancer therapy (including chemotherapy,<br> immunotherapy, hormonal therapy and herbal/alternative therapies with anti-cancer<br> indications, or targeted therapy) administered within 28 days or 5 half-lives,<br> whichever is shorter, before the first dose of study drug.<br><br> 3. Any previous treatment-related toxicities have not recovered, i.e. to = Grade 1, as<br> evaluated by NCI-CTCAE version 5.0 or baseline, except alopecia and anemia. Patients<br> with chronic Grade 2 toxicities which are well managed and stable may be eligible<br> per the discretion of the investigator after the discussion with the Sponsor and<br> medical monitor, e.g., Grade 2 chemotherapy-induced neuropathy.<br><br> 4. Primary tumor in CNS, or active or untreated CNS metastases and/or carcinomatous<br> meningitis. Patients with previously treated brain metastases may participate<br> provided they are clinically stable for at least 28 days and have no evidence of new<br> or enlarging brain metastases and no requirements for high-dose corticosteroids 14<br> days prior to dosing with study drug. Patients on low dose corticosteroids (< 20 mg<br> prednisone or equivalent per day) may participate.<br><br> 5. Clinically significant cardiovascular condition, including:<br><br> - History of congestive heart failure (New York Heart Association [NYHA] Class ><br> 2)<br><br> - History of unstable angina<br><br> - New-onset angina or myocardial infarction within the 6 months prior to the<br> first dose of study drug<br><br> - New onset of atrial fibrillation, supraventricular arrhythmia, or ventricular<br> arrhythmia within the 6 months prior to the first dose of study drug and<br> requiring treatment or intervention. History of atrial fibrillation,<br> supraventricular arrhythmia, or ventricular arrhythmia will be allowed provided<br> the condition is stably controlled.<br><br> 6. History or presence of an abnormal ECG that, in the Investigator's opinion, is<br> clinically meaningful (including QTcF > 470 msec for females, QTcF > 450 msec for<br> males by Fridericia formula at screening, pacemaker installation or previous<br> diagnosis of congenital long QT syndrome).<br><br> 7. Patients who have undergone a major surgery or have undergone a radical radiotherapy<br> within 28 days prior to the first dose of study drug or have undergone a palliative<br> radiotherapy within 14 days prior to the first dose of study drug, or have used a<br> radioactive drug (Strontium, Samarium, etc.) within 56 days prior to first dose of<br> study drug.<br><br> 8. Patients with infections, including:<br><br> - An uncontrolled acute infection, or an active infection requiring systemic<br> treatment, or patients who have received systemic antibiotics within 14 days<br> prior to the first dose of the study drug; prophylaxis use of systemic<br> antibiotics treatment for upper tract infection is allowed as long as there is<br> no violation with the requirement of concomitant medications.<br><br> - A known history of human immunodeficiency virus (HIV) infection and/or acquired<br> immunodeficiency syndrome or positive HIV testing should undergo CD4+ T-cell<br> test during the screening period. Patients with CD4+ T-cell counts < 350<br> cells/µL are ineligible for enrolment as well as patients with unknown HIV<br> infection status who are unwilling to undergo HIV testing.<br><br> - A known active hepatitis B or C. To be included in the study, patients with<br> hepatitis B virus surface antigen (HBsAg) or hepatitis C virus (HCV) antibody<br> positive test results during screening must be further tested for hepatitis B<br> virus (HBV) DNA titer (excluding patients with a DNA titer of more than 2500<br> copies [cps]/mL or 500 IU/mL) and HCV ribonucleic acid (RNA) (excluding<br> patients with an HCV RNA concentration exceeding the lower detection limit of<br> the assay) to exclude active hepatitis B or hepatitis C infection requiring<br> treatment. Hepatitis B virus carriers, patients with stable hepatitis B<br> infection after drug treatment (DNA titer not exceeding 2500 copies [cps]/mL or<br> 500 IU/mL) and hepatitis C infected patients who received treatment and<br> achieved sustained virologic response for at least 12 weeks can be enrolled.<br> Note: If the lower detection limit of the HBV DNA assay is higher than 2500<br> copies [cps]/mL or 500 IU/mL, the patients with an HBV DNA assay result lower<br> than the lower detection limit of the assay can be enrolled.<br><br> - Active tuberculosis.<br><br> 9. Positive test result for severe acute respiratory syndrome-related coronavirus<br> (SARS-CoV-2) test. SARS-CoV-2 test is mandatory during screening for patients
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of adverse events (Safety and Tolerability);To determine the Maximum Tolerable Dose
- Secondary Outcome Measures
Name Time Method To determine Maximum concentration (Cmax);To determine area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC0-t);To assess Overall response rate (ORR);To assess Disease control rate (DCR);To assess Duration of response(DOR);To assess Progression free survival(PFS);To assess Overall survival(OS);To assess QT interval