Last updated 16 months ago
Study of IMX-110 in Combination With Tislelizumab in Patients With Advanced Solid Tumors
60 patients around the world
Available in Brazil
Immix Biopharma, Inc.
2Research sites
60Patients around the world
This study is for people with
Solid tumors
Requirements for the patient
From 16 Years
All Gender
Medical requirements
- Male or female patients who are 16 years or olderPatients with confirmed advanced solid tumor as per histology, who have progressed, are refractory, or are intolerant to standard therapy appropriate for tumor typePatients with an Eastern Cooperative Oncology Group (ECOG) Performance status of 0-2 (Appendix 2)Patients with a life expectancy of at least 3 monthsPatients with adequate cardiac function as measured by left ventricular ejection fraction >50%Patients who have not reached a cumulative total lifetime maximum dose of 550 mg/m2 doxorubicin or per investigator discretionPatients who meet the following laboratory requirements:Women of childbearing potential and men must agree to sexual abstinence or to use highly effective, double barrier contraception during the study and for 6 weeks following the final dose of IMX-110. Double barrier contraception is defined as a condom AND one other form of the following:Male patients must not donate sperm for at least 24 weeks post-dose of the last study treatment.Females of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day -1.Rhythm methods during the study and for 4 months after the dose of IMX-110 + Tislelizumab will not be acceptable.
- Patients with a history of severe allergic reactions to any unknown allergens or any components of the study drug formulation.Patients receiving any chemotherapy within 14 days of dosing, immunotherapy within 28 days of dosing, or biologic or hormonal therapy within 28 days of dosing for cancer treatment (exclusively). Patients with prostate cancer can continue administration of Gonadotropin-releasing hormone (GnRH) agonists.Subject participating in any other drug study ≤ 4 weeks (6 weeks for immunotherapy investigational agents) or 5 half-lives of the investigational product, whichever is longer, prior to study drug administration or is scheduled to receive one during the treatment or post-treatment period.Patients who are expected to need surgery or benefit from other anti-cancer therapy to be initiated during the study period.Patients with a history of and/or risk factors for ischemic heart disease, congestive heart failure, symptomatic bradycardia, atrioventricular (AV) block of second degree or higher grade, prolonged QTcF interval (>450 msec in men and >470 msec in women and additional risk factors for QT prolongation (e.g. hyperthyroidism, electrolyte imbalance). (Pacemaker is not prohibited).Patients who have not recovered from adverse events (AEs; ≥ CTCAE grade 2) due to prior treatment (i.e. chemotherapy, targeted therapy, radiation, or surgery) within 7 days prior to Cycle 1 Day 1, unless deemed to be irreversible, or approved by the Sponsor and Medical Monitor.Females who are pregnant or lactating or intend to become pregnant before, during, or within 24 weeks after participating in this study; or intending to donate ova during such time period.Patients with a known positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C antibodies (HCV). Patients may be enrolled if they have HBV, HCVor HIV with viral load suppressed by anti-virals.Any condition that, in the opinion of the investigator or sponsor, would interfere with evaluation of the investigational product.Active autoimmune diseases or history of autoimmune diseases that may relapse or history of life-threatening toxicity related to prior immune therapy. Note: Patients with the following diseases are not excluded and may proceed to further screening:Indicated live vaccines should be given ≥4 weeks prior to enrollment
Sites
Fundação Faculdade de Medicina - Instituto do Cancer do Estado de São Paulo
Recruiting
Centro de Estudos e Pesquisas de Hematologia e Oncologia - CEPHO
Recruiting
StudyIMMINENT-01
SponsorImmix Biopharma, Inc.
Conditions
Solid tumors
Requirements
From 16 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05840835
