Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: Synnovation Therapeutics, Inc.
No Placebo Group
Trial Summary
What is the purpose of this trial?This study is testing a new medicine, SNV4818, for people with advanced cancers. The researchers want to find out if SNV4818 is safe, well-tolerated, and effective in treating solid tumors. They are investigating different doses in order to find the safest and most effective one.
Do I have to stop taking my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.
What safety data exists for SNV4818 or similar treatments?
The research articles do not provide specific safety data for SNV4818, but they discuss cardiovascular risks associated with similar cancer treatments, like tyrosine kinase inhibitors, which can cause heart-related side effects such as heart failure and blood clots.
12345Eligibility Criteria
This trial is for individuals with advanced solid tumors. Participants must have a type of cancer that has progressed despite treatment, or for which no standard treatment exists.Inclusion Criteria
My cancer has a PIK3CA mutation.
I am fully active or restricted in physically strenuous activity but can do light work.
Exclusion Criteria
I have type 1 diabetes or my type 2 diabetes is not under control.
My organs are not functioning properly.
I have been diagnosed with a brain or spinal cord tumor.
I have active brain tumors or cancer in the lining of my brain.
Participant Groups
The study is evaluating the safety and effectiveness of a new medication called SNV4818, in various doses, to treat advanced cancers. It's also comparing SNV4818's effects when used alone versus combined with Fulvestrant.
2Treatment groups
Experimental Treatment
Group I: SNV4818+Fulvestrant CombinationExperimental Treatment2 Interventions
Participants will receive oral, daily doses of SNV4818 in combination with a standard dose of Fulvestrant as part of either dose escalation or dose expansion cohorts.. The SNV4818 dose level participants receive will depend upon the study part to which they are assigned. Dose escalation participants will be assigned to small cohorts of ascending SNV4818 dose levels. Dose expansion participants will receive one of the SNV4818 dose levels recommended for further evaluation.
Group II: SNV4818 MonotherapyExperimental Treatment1 Intervention
Participants will receive oral, daily doses of SNV4818 as a single agent as part of either dose escalation or dose expansion cohorts. The SNV4818 dose level participants receive will depend upon the study part to which they are assigned. Dose escalation participants will be assigned to small cohorts of ascending SNV4818 dose levels. Dose expansion participants will receive one of the SNV4818 dose levels recommended for further evaluation.
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
The University of Texas M.D. Anderson Cancer CenterHouston, TX
Sarah Cannon Research InstituteNashville, TN
University Health Network, Princess Margaret Cancer CentreToronto, Canada
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Who is running the clinical trial?
Synnovation Therapeutics, Inc.Lead Sponsor
References
Cardiovascular toxicity of anticancer-targeted therapy: emerging issues in the era of cardio-oncology. [2022]Over the last decade, the advent of molecular targeted therapy radically changed the treatment of several forms of cancer. However, these innovative anticancer drugs, namely monoclonal antibodies and small molecule tyrosine kinase inhibitors were found to adversely affect cardiovascular function. These "on-target" and "off-target" drug side effects encompass a wide range of cardio toxicities, including left ventricular dysfunction leading to heart failure, electrocardiographic abnormalities with dysrhythmias, hypertension, myocardial ischemia and thromboembolic events. The unclear incidence of drug-induced cardiovascular events together with uncertainty on their reversibility and long-term safety call for a multidisciplinary effort embracing cardio-oncological expertise supported by primary care physicians, pharmacologists and toxicologists. Here we address emerging cardiovascular events associated with targeted anticancer drugs by offering a concise review on: (1) mechanistic basis subtending cardiotoxicity and (2) clinical advice for effective patient management (i.e., detection, treatment, monitoring and reporting of cardiovascular side effects). In this scenario, onco-vigilance (i.e., pharmacovigilance oriented to oncologic drugs) is emerging as a key to support cardio-oncologists in appropriateness [corrected].
A phase I open-label trial evaluating the cardiovascular safety of regorafenib in patients with advanced cancer. [2022]To characterize the cardiovascular safety profile of regorafenib in patients with advanced cancer.
[Vascular adverse events of ponatinib during treatment of Philadelphia chromosome-positive leukemia: a retrospective single-institution analysis]. [2020]Ponatinib (PON) is a key drug for patients with second tyrosine kinase inhibitor (TKI)-resistant/intolerant Philadelphia chromosome-positive leukemia (Ph+ leukemia); however, the occurrence of vascular adverse events (VAEs) in patients treated with PON should be carefully monitored. A retrospective analysis involving seven patients treated with PON was conducted to elucidate the incidence rate and risk factor for the development of VAEs. In the present study, risk assessment and monitoring of VAEs were performed using SCORE Risk Chart and Suita Score (10-year risk for fatal cardiovascular event), respectively. Despite the prophylactic use of aspirin, cerebral infarction and unstable angina occurred in two patients. By contrast, deep vein thrombosis did not improve in a patient treated with edoxaban. Our data suggest that patients with Ph+ leukemia possessing risk factors, medical history of lifestyle diseases, and administration of long-term second TKI treatment require careful monitoring of VAEs and therapeutic intervention to lifestyle diseases.
Ponatinib Drives Cardiotoxicity by S100A8/A9-NLRP3-IL-1β Mediated Inflammation. [2023]The tyrosine kinase inhibitor ponatinib is the only treatment option for chronic myelogenous leukemia patients with T315I (gatekeeper) mutation. Pharmacovigilance analysis of Food and Drug Administration and World Health Organization datasets has revealed that ponatinib is the most cardiotoxic agent among all Food and Drug Administration-approved tyrosine kinase inhibitors in a real-world scenario. However, the mechanism of ponatinib-induced cardiotoxicity is unknown.
Analysis of Anti-Angiogenesis-Related Adverse Events Associated with Vascular Endothelial Growth Factor Receptor-Tyrosine Kinase Inhibitors (VEGFR-TKIs) in Patients with Metastatic Renal Cell Carcinoma. [2023]Limited studies have evaluated anti-angiogenesis-related adverse events involving oral vascular endothelial growth factor receptor-tyrosine kinase inhibitors (VEGFR-TKIs) in metastatic renal cell carcinoma using real-world data.