[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"mtap-deleted-solid-tumors\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:mtap-deleted-solid-tumors":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,49],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100586342","phase-1-a-study-of-prmt5-inhibitor-bay-3713372-in-participants-with-mtap-deleted-solid-tumors-100586342",false,"NCT06914128","A Study of PRMT5 Inhibitor BAY 3713372 in Participants With MTAP-deleted Solid Tumors","A First-in-human Study to Evaluate the Safety, Tolerability and Pharmacokinetics, Pharmacodynamics and Preliminary Clinical Activity of BAY 3713372, a Novel 2nd Generation PRMT5 Inhibitor, in Participants With MTAP-deleted Solid Tumors.","Inclusion Criteria:\n\n* Participant must be ≥ 18 years old of age, or the legal age of consent in the jurisdiction of the country in which the study takes place, at the time of signing the informed consent.\n* At least one measurable lesion that would qualify as target lesion by Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1).\n* Homozygous MTAP-deletion identified through molecular testing from a locally certified laboratory.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n\nExclusion Criteria:\n\n* Previous additional cancer other than the one evaluated in this study within the past 2 years except for basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, superficial bladder tumors, localized prostate cancer or other tumors that in the opinion of the investigator, are considered cured or not immediately life-threatening, and will not interfere with the scientific goals of this study.\n* A marked prolongation of QT\u002FQTc interval at screening (e.g., repeated demonstration of a QTc interval \\>450 ms). Participants with permanent pacemakers (i.e., a paced rhythm) may be eligible based on the investigator's clinical assessment and discretion.\n* Cardiac history comprising:\n\n  * History of congestive heart failure Class \\>II according to the New York Heart Association Functional Classification.\n  * Myocardial infarction less than 6 months before the start of study intervention.\n  * Serious cardiac arrhythmias requiring treatment or any clinically important abnormalities in rhythm, conduction or morphology on resting ECG with the exception of atrial fibrillation which is well-controlled and requires only digoxin or beta blockers.\n* Unstable angina within 4 weeks before start of study intervention.","ALL","18 Years",{"count":19,"type":20},450,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","The study treatment, BAY 3713372, is under development to treat MTAP (methylthioadenosine phosphorylase)-deleted solid tumors. It is thought to work by blocking the protein arginine N-methyltransferase 5 (PRMT5). This may kill the MTAP-deleted cancer cells while sparing the normal cells.\n\nThe main objective of this first-in-human study is to learn how safe BAY 3713372 is, how the body processes it, and how well it works in people with MTAP-deleted solid tumors.\n\nFor this, the researchers will study and analyze:\n\n* the number of participants who have adverse events (AEs) after receiving different doses of BAY 3713372 and the AE's severity.\n* the number of participants who experience dose-limiting toxicities (DLTs) after receiving different doses of BAY 3713372, the DLT's severity and how often they happened. A DLT is a pre-defined medical problem caused by a specific dose of a drug that is too severe to continue using that dose.\n* the total amount of BAY 3713372 in participants' blood (also called AUC) over time after single and multiple doses.\n* the highest level of BAY 3713372 in participants' blood (also called Cmax) after single and multiple doses.\n\nOther than the main objective, researchers will also check for the number of participants who show a response to treatment and how long they live without the cancer getting worse.\n\nThe study participants will take part in one of the eight distinct groups or \"intervention cohorts\" of the study. The study will start with a dose escalation phase where distinct groups of participants will receive different doses of BAY 3713372 alone to find the dose that is deemed safe and works best for the participants. When this dose has been found, a larger number of participants will receive BAY 3713372 alone or with other treatments in a dose expansion phase.\n\nParticipants may take the study treatment as long as they benefit from the treatment without any severe medical problems.\n\nParticipants will visit the study site:\n\n* at least twice before the treatment starts\n* multiple times when they start taking the treatment\n* once after 30 days of receiving the last dose and every 9 weeks after that until the cancer worsens, or the participant stops for any other reason\n\nDuring the study, the doctors and their study team will:\n\n* check participants' health by performing tests such as blood and urine tests, and checking heart health using an electrocardiogram\n* check if the participants' cancer has grown and\u002For spread using computed tomography (CT) or magnetic resonance imaging (MRI) and, if needed, bone scan\n* take tumor samples\n\nThe study doctors and their team will contact the participants every 3 months until 2 years after the last participant's last dose or the end of the study to learn about the participant's health.",[27],"MTAP-deleted Solid Tumors",[29,30,31,32,33,34,35],"Solid Tumors","Non-small cell lung cancer","NSCLC","Pancreatic adenocarcinoma","PDAC","Glioblastoma","GBM","RECRUITING","2026-06-25",{"date":39,"type":40},"2026-06-26","ACTUAL",{"date":42,"type":40},"2025-03-21",{"date":44,"type":20},"2029-06-17",{"name":46,"class":47},"Bayer","INDUSTRY",60,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":21,"phases":58,"briefSummary":59,"conditions":60,"keywords":63,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":75},"100590933","phase-1-a-study-of-pep08-in-patients-with-mtap-del-advanced-or-metastatic-solid-tumors-100590933","NCT06973863","A Study of PEP08 in Patients With MTAP-Del Advanced or Metastatic Solid Tumors","A Phase 1a\u002F1b Study Evaluating the Clinical Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Anti-tumor Efficacy of PEP08 as Monotherapy and Combination Therapy in MTAP-Del Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\n* Participants must be adults (≥18 years) and sign informed consent before undergoing any study-related procedures.\n* Eligible participants must have advanced or metastatic solid tumors that are not treatable with surgery or radiation, and show evidence of MTAP gene homozygous deletion or MTAP protein loss based on tumor tissue analysis.\n* Participants must have previously received standard treatment for their cancer type, and either experienced disease progression, be refractory, or be intolerant to such therapies.\n* At least one measurable lesion is required, evaluated by standard imaging criteria (RECIST v1.1).\n* Good general physical condition (ECOG performance status 0-1 for dose escalation; broader range allowed for other parts).\n* Adequate function in key organs.\n* Able to swallow oral medication and comply with study requirements.\n* Women of childbearing potential and men with reproductive potential must use effective contraception during and after the study.\n\nExclusion Criteria:\n\n* Recent cancer treatment, immunotherapy, or investigational drugs are not allowed before starting the study.\n* Live vaccines received shortly before treatment are not allowed.\n* Previous use of drugs with similar mechanisms to the study treatment is not allowed.\n* Active or unstable brain or meningeal metastases, unless previously treated and stable without needing local treatment or high-dose steroids.\n* History of other cancers within the last 2 years, unless low-risk and treated (e.g., in situ or certain skin cancers).\n* Uncontrolled disease-related complications (e.g., abnormal calcium levels, fluid buildup around organs).\n* Active HIV, hepatitis B or C infections that are not well-controlled.\n* Ongoing serious infections or systemic conditions requiring isolation.\n* Significant heart disease, such as recent heart failure, ischemia, or arrhythmias.\n* History of severe digestive conditions or surgeries affecting drug absorption.\n* Recent major surgery.\n* Unresolved serious side effects from prior cancer treatment.\n* Currently pregnant or breastfeeding.\n* Poorly controlled blood pressure or lung conditions.\n* Other serious illnesses (e.g., severe anemia, psychiatric or social issues affecting study compliance).\n* Any condition that may pose a safety risk or interfere with the study, as judged by the investigator.\n* Known drug or substance abuse that may affect study participation.\n* Allergy to the study drug or any of its components.",{"count":57,"type":20},40,[23],"This is a first-in-human clinical study of PEP08, a novel cancer therapy being evaluated both as monotherapy and in combination with other treatments in patients with advanced or metastatic solid tumors harboring MTAP deletion.\n\nThe study will be conducted in three parts, with Part 1 currently open for enrollment.\n\nThe primary objectives of the study are to:\n\n* Evaluate the safety and tolerability of PEP08, PK and PD\n* Determine the maximum tolerated dose (MTD) and\u002For recommended Phase 2 dose (RP2D)\n* Assess preliminary signs of anti-tumor activity of PEP08\n\nKey study questions include:\n\n* What is the recommended dose of PEP08 for further development?\n* Wht is the tolerable dose of PEP08 when administered alone or in combination?\n* Does PEP08 show early evidence of clinical activity in patients with MTAP-deleted tumors?\n\nParticipants in the study will:\n\n* Receive PEP08 alone or in combination with another anti-cancer agent, depending on the study part\n* Attend regular clinic visits for treatment administration, laboratory assessments, and tumor evaluations\n* Be enrolled in one of the following study phases over time:\n* \\- Part 1: Monotherapy dose escalation (currently enrolling).\n* \\- Parts 2 and 3 (monotherapy extension and combination therapy) will be activated in future protocol amendments.",[61,29,27,62],"Advanced Solid Tumor","MTAP Deletion",[64,65],"MTAP-del","PRMT5 inhibitor","2026-02-10",{"date":68,"type":40},"2026-02-13",{"date":70,"type":40},"2025-08-26",{"date":72,"type":20},"2028-03",{"name":74,"class":47},"PharmaEngine",4]