[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"mtap-deletion\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:mtap-deletion":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,45,84,109],{"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":24,"conditions":25,"keywords":30,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100564533","phase-2-pemetrexed-response-in-relation-to-tumor-alterations-of-gene-status-for-the-treatment-of-patients-with-metastatic-urothelial-bladder-cancer-and-other-solid-tumors-100564533",false,"NCT06630416","Pemetrexed Response in Relation to Tumor Alterations of Gene Status for the Treatment of Patients With Metastatic Urothelial Bladder Cancer and Other Solid Tumors","A Phase II Trial to Evaluate Pemetrexed Response in Relation to Tumor Alterations of Gene Status in Patients With Previously Treated Metastatic Urothelial Carcinoma and Other Solid Tumors","Inclusion Criteria:\n\n* Patients must have pathologically or cytologically confirmed metastatic urothelial bladder carcinoma (Arm A) or other metastatic\u002Flocally-advanced solid malignancy (Arm B) and MLL4- protein (KMT2D-gene) or UTX-protein (KDM6A-gene) or MTAP loss of function mutation including but not limited to SNVs that cause truncation, CNVs, and indels confirmed by next generation sequencing or immunohistochemistry techniques.\n* Patients must have at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), measured preferably by computed tomography (CT) scan.\n* Patients who have received any prior neoadjuvant or systemic chemotherapy are eligible.\n\n  * Notes:\n\n    * Patients must have progressive disease despite two prior lines of therapy in the metastatic setting or locally advanced setting unless the patient was not suitable for an approved second line regimen due to intolerance or another clinical factor;\n    * Treatment cannot have included prior pemetrexed. Any prior intravesical therapy, or immunotherapy is allowed. At least 3 weeks (21 days) wash-out period since prior chemotherapy or radiation therapy or targeted agent is required.\n* Patients must be aged ≥ 18 years.\n* Patients must exhibit an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.\n* Patients must have adequate organ and bone marrow function as defined:\n* Absolute neutrophil count (ANC) ≥ 1,500\u002FmcL (growth factor allowed and can be added at the discretion of the treating oncologist)\n* Hemoglobin (Hgb) ≥ 8.5 g\u002FdL (without the need for transfusion within the previous one week)\n* Platelets (PLT) ≥ 100,000\u002FmL (without the need for platelet transfusion within the previous one week)\n* Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN), except subjects with Gilbert's syndrome or liver metastases, who must have a baseline total bilirubin ≤ 3.0 mg\u002FdL\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\]) ≤ 3 x institutional ULN or ≤ 5 x ULN if documented liver metastases are present\n* Alanine aminotransferase (ALT) (serum glutamic-pyruvic transaminase \\[SGPT\\]) ≤ 3 x institutional ULN or ≤ 5 x ULN if documented liver metastases are present\n* Creatinine clearance ≥ 45 mL\u002Fmin\u002F1.73 m\\^2 using the standard Cockcroft and Gault formula\n* Patients must have the ability to comply with the administration of supplemental therapies including folic acid, vitamin B12 and steroids as directed by study team and as per standard of care and institutional standards and practice for pemetrexed use.\n* Patients must be able swallow oral medication or not have problems\u002Fdiseases that affect absorption or oral medication.\n* Patients with a known history of human immunodeficiency virus (HIV), infected patients on effective anti-retroviral therapy must have a viral load undetectable for 6 months prior to registration. Please note this lab is not a requirement for eligibility, however, if it was previously done as part of the patient's health care, it should be documented for eligibility.\n* Patients with a known history of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Please note this lab is not a requirement for eligibility, however, if the lab has been completed previously as part of the patient's health care, then it should be documented for eligibility.\n* Patients with a known history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with a known HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load. Please note this lab is not a requirement for eligibility, however if it was previously done as part of the patient's health care, it should be documented for eligibility.\n* Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression.\n* Pemetrexed is known to be teratogenic. For this reason, patients of child-bearing potential (POCBP) and their partners with sperm-producing reproductive capacity must agree to use adequate contraception from time of informed consent, for the duration of study participation, and for 180 days following completion of pemetrexed therapy. Should a POCBP become pregnant or suspect they are pregnant while they or their partner are participating in this study, they should inform their treating physician immediately. Patients with sperm-producing reproductive capacity (PWSPRC) treated or enrolled on this protocol must also agree to use adequate contraception with partners of childbearing potential from time of informed consent, for the duration of study participation, and 180 days after completion of administration\n\n  * Note: A POCBP is any patient (regardless of gender, sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) with an egg-producing reproductive tract who meets the following criteria:\n\n    * Has not undergone a hysterectomy or bilateral oophorectomy\n    * Has had menses at any time in the preceding 12 consecutive months (and therefore has not been naturally postmenopausal for \\> 12 months)\n* POCBP must have a negative pregnancy test prior to registration on study.\n* The ability to interrupt nonsteroidal anti-inflammatory drugs (NSAIDS) or aspirin at higher dose (\\> 1.3 g per day) 2 days before (5 days for long-acting NSAIDs), the day of, and 2 days following administration of pemetrexed.\n* Patients must be able to understand and voluntarily sign a written informed consent and willing and able to comply with the protocol requirements including scheduled visits, treatment plan, laboratory tests and other study procedures.\n\nExclusion Criteria:\n\n* Patients who received prior pemetrexed containing chemotherapy.\n* Patients who have had chemotherapy or radiotherapy ≤ 21 days (prior to planned treatment start date). For palliative radiation, 5 day wash out is sufficient.\n* Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \\> grade 1) with the exception of alopecia, neuropathy and other non-significant adverse events deemed not clinically significant by the treating investigator, adverse events per National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v 5.0).\n* Patients who are receiving any other investigational agents. A 21 day wash out period will be required after discontinuation of an investigational agent prior to first day of study treatment.\n* Patients who have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to pemetrexed.\n* Patients who have an uncontrolled intercurrent illness including, but not limited to any of the following:\n\n  * Ongoing or active infection requiring systemic treatment\n  * Symptomatic congestive heart failure\n  * Unstable angina pectoris\n  * Any other illness or condition that the treating investigator feels would interfere with study compliance or would compromise the patient's safety or study endpoints\n* Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen.\n* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification.\n\n  * Note: To be eligible for this trial, patients should be class 2B or better\n* Patients with presence of third space fluid which cannot be controlled by drainage\n\n  * Note: For patients who develop or have baseline clinically significant pleural or peritoneal effusions (on the basis of symptoms or clinical examination) before or during initiation of pemetrexed therapy, consideration should be given to draining the effusion prior to dosing. However, if, in the investigator's opinion, the effusion represents progression of disease, the patient should be discontinued from study therapy\n* Has received the final dose of any of the following treatments\u002F procedures with the specified minimum intervals before first dose of study drug:\n\n  * Focal radiation therapy - 7 days\n  * Surgery with general anesthesia - 7 days\n  * Surgery with local anesthesia - 3 days\n  * For palliative radiation - 5 days\n* Patients of child bearing (POCB) potential who are pregnant or nursing.\n\n  * Note: Registration of patients is completed in Northwestern Oncology Trial Information System (NOTIS)","ALL","18 Years",{"count":19,"type":20},64,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This phase II trial tests how well pemetrexed works in treating patients with urothelial bladder cancer and other solid tumors that have spread from where they first started (primary site) to other places in the body (metastatic) with mutations that result in a loss of function in the MLL4-protein\u002FKMT2D-gene or UTX-protein\u002FKDM6A-gene or MTAP enzyme. Loss of function due to a genetic mutation means a gene's activity may be reduced or eliminated. Mutations that result in a loss of function in the MLL4-protein or KMT2D-gene are found in 9.96% of all cancers including bladder carcinoma patients, esophageal squamous cell carcinoma and esophageal adenocarcinoma patients. In addition, mutations that result in a loss of function in the UTX-protein or KDM6A-gene are found in approximately 5% of all tumors, including bladder cancers, endometrial cancer, and esophagogastric cancer amongst many other tumor types. Pemetrexed is in a class of medications called antifolate antineoplastic agents. It works by stopping cells from using folic acid to make deoxyribonucleic acid and may kill tumor cells. Giving pemetrexed may increase response in patients with metastatic urothelial bladder cancer and other solid tumors with the loss of function in the MLL4-protein\u002FKMT2D-gene or UTX-protein\u002FKDM6A-gene or MTAP enzyme.",[26,27,28,29],"Metastatic Bladder Urothelial Carcinoma","Metastatic Malignant Solid Neoplasm","Stage IV Bladder Cancer AJCC v8","MTAP Deletion",[31],"KMT2D (gene)\u002FMLL4 (protein) or KDM6A (gene)\u002FUTX (protein) or MTAP loss of function mutations","RECRUITING","2026-06-10",{"date":35,"type":36},"2026-06-12","ACTUAL",{"date":38,"type":36},"2024-11-27",{"date":40,"type":20},"2030-05-10",{"name":42,"class":43},"Northwestern University","OTHER",2,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":21,"phases":54,"briefSummary":56,"conditions":57,"keywords":65,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":83},"100586992","phase-1-study-to-evaluate-the-safety-tolerability--efficacy-of-tng462-in-combination-in-pdac--nsclc-patients-100586992","NCT06922591","Study to Evaluate the Safety, Tolerability & Efficacy of TNG462 in Combination in PDAC & NSCLC Patients","A Phase 1\u002F2, Multicenter, Open-Label Study to Evaluate Safety, Tolerability & Antitumor Activity of TNG462 in Combination With Other Agents in Patients With Pancreatic Cancer With MTAP Loss and Pancreatic or Non-Small Cell Lung Cancer With MTAP Loss & RAS Mutation","Inclusion Criteria:\n\n1. Is ≥18 years of age at the time of signature of the main study ICF.\n2. Has an ECOG PS of 0 or 1.\n3. Has a tumor with loss of MTAP protein or bi-allelic deletion of the MTAP gene\n4. Arms A and B only: Has a tumor with a RAS mutation\n5. Pathologically documented metastatic PDAC or locally advanced, recurrent or metastatic NSCLC\n6. Has received prior standard therapy\n7. Arms A and B only: Must not have received prior RAS-targeted therapy\n8. Has evidence of measurable disease based on RECIST v1.1.\n9. Adequate organ function\n10. Must be able to swallow tablets.\n11. Negative pregnancy test at screening\n12. Written informed consent must be obtained according to local guidelines\n\nExclusion Criteria:\n\n1. Has received prior treatment with a PRMT5 inhibitor, or MAT2A inhibitor\n2. Arms A and B only: Prior enrollment in any phase 3 clinical trial of RMC-6236 or RMC-9805\n3. Known allergy, hypersensitivity or intolerance to TNG462 (all arms), RMC-6236 Arm A), RMC-9805 (Arm B), mFOLFIRINOX (Arm C), gemcitabine\u002Fnab-paclitaxel (Arm D) or their excipients\n4. Has uncontrolled intercurrent illness that will limit compliance with the study requirements.\n5. Has an active infection requiring systemic therapy.\n6. Is currently participating in or has planned concurrent participation in a study of another investigational agent or device.\n7. Has impairment of GI function or disease that may significantly alter the absorption of the oral medications\n8. Has known or suspected active or untreated CNS metastases associated with progressive neurological symptoms\n9. Has current active liver disease from any cause\n10. Is known to be HIV positive, unless all the following criteria are met:\n\n    1. CD4+ count ≥300\u002FµL.\n    2. Undetectable viral load.\n    3. Receiving highly active antiretroviral therapy\n11. Has clinically relevant cardiovascular disease\n12. History of or presence of active interstitial lung disease\n13. Is a female patient who is pregnant or lactating\n14. Is unwilling or unable to comply with the scheduled visits, study treatment administration plan, laboratory tests or other study procedures and study restrictions.\n15. Has a prior or ongoing clinically significant illness, medical condition, surgical history, physical finding, or laboratory abnormality that, in the investigator's opinion may affect the safety of the patient or impair the ability to assess study results",{"count":53,"type":20},183,[55,23],"PHASE1","TNG462-C102 is a Phase 1\u002F2, open-label, multicenter study designed to determine the safety, tolerability, PK, PD, and preliminary antineoplastic activity of oral TNG462 in combination with RMC-6236, RMC-9805, mFOLFIRINOX or gemcitabine\u002Fnab-paclitaxel. The study comprises a dose escalation phase and a dose expansion phase.",[58,59,60,61,29,62,63,64],"PDAC","PDAC - Pancreatic Ductal Adenocarcinoma","NSCLC","RAS Mutation","Lung Cancer","Pancreatic Cancer Metastatic","Thoracic Cancer",[66,67,68,69,70,71,72],"PRMT5 inhibitor","RAS G12D","Multi RAS","RMC-9805","RMC-6236","Thoracic","Targeted therapy","2026-05-12",{"date":75,"type":36},"2026-05-14",{"date":77,"type":36},"2025-05-31",{"date":79,"type":20},"2027-12",{"name":81,"class":82},"Tango Therapeutics, Inc.","INDUSTRY",18,{"id":85,"slug":86,"hasResults":11,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":4,"eligibilityCriteria":90,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":91,"enrollmentInfo":92,"targetDuration":4,"studyType":21,"phases":94,"briefSummary":95,"conditions":96,"keywords":97,"overallStatus":99,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":4},"100636605","phase-1-a-study-of-hs-10587-in-patients-with-advanced-solid-tumors-100636605","NCT07567859","A Study of HS-10587 in Patients With Advanced Solid Tumors","An Open-Label, Multi-Center Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic\u002FPharmacodynamic Characteristics, and Preliminary Efficacy of HS-10587 in Patients With Methylthioadenosine Phosphorylase (MTAP)-Deleted Advanced Solid Tumors","Inclusion Criteria:\n\n1. Participants who voluntarily participate in this clinical study, understand the study procedures, and are able to sign a written ICF.\n2. Participants with locally advanced or recurrent metastatic malignant solid tumors confirmed by histopathology or cytopathology who have failed or are intolerant to at least one line of prior standard treatment, or for whom no standard treatment exists.\n3. Evidence of MTAP deletion in the tumor tissue.\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n5. Life expectancy ≥12 weeks.\n6. At least one measurable lesion that would qualify as target lesion by Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1).\n7. Female participants of childbearing potential are willing to take appropriate contraceptive measures and should not breastfeed; male participants are willing to use barrier contraception.\n\nExclusion Criteria:\n\n1. History of other primary malignancies.\n2. Presence of pleural\u002Fabdominal effusion or pericardial effusion requiring clinical intervention.\n3. Presence of leptomeningeal metastasis, spinal cord compression, or brainstem metastasis; known untreated brain metastases, or symptomatic\u002Funstable brain metastases.\n4. Participants who have any Grade ≥ 2 residual toxicity according to Common Terminology Criteria for Adverse Events (CTCAE, version 6.0) from prior anti-tumor therapies (except alopecia, pigmentation, and residual neurotoxicity).\n5. Inadequate bone marrow reserve or hepatic and renal functions.\n6. Severe, uncontrolled, or active cardiovascular diseases.\n7. Severe or poorly controlled diabetes.\n8. Severe or poorly controlled hypertension.\n9. Severe infection within 4 weeks prior to the first dose.\n10. Long-term corticosteroid therapy, history of other acquired\u002Fcongenital immunodeficiency disorders, or organ transplantation.\n11. Known active infectious diseases.\n12. Clinically significant gastrointestinal dysfunction.\n13. Moderate to severe pulmonary diseases that seriously affect respiratory function.\n14. Prior history of severe neurological or mental disorders.\n15. Female participants who are pregnant or breastfeeding, or plan to become pregnant during the study.\n16. History of severe allergies, or history of hypersensitivity reactions to any active or inactive ingredients of HS-10587 or to drugs with similar chemical structures to HS-10587 or drugs of the same class as HS-10587.\n17. Participants with any conditions that may jeopardize participant safety or interfere with study assessments, as judged by the investigator.","75 Years",{"count":93,"type":20},362,[55],"This is a Phase I, multicenter, open-label clinical trial with dose escalation\u002Fdose expansion phases, designed to evaluate the safety, tolerability, pharmacokinetic\u002Fpharmacodynamic (PK\u002FPD) profiles, and antitumor efficacy characteristics of HS-10587 in patients with MTAP-deleted advanced solid tumors.",[29],[98],"Advanced Solid Tumors","NOT_YET_RECRUITING","2026-04-28",{"date":102,"type":36},"2026-05-05",{"date":104,"type":20},"2026-06-04",{"date":106,"type":20},"2028-06-30",{"name":108,"class":82},"Jiangsu Hansoh Pharmaceutical Co., Ltd.",{"id":110,"slug":111,"hasResults":11,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":4,"eligibilityCriteria":115,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":116,"targetDuration":4,"studyType":21,"phases":118,"briefSummary":119,"conditions":120,"keywords":124,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":5},"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":117,"type":20},40,[55],"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.",[121,122,123,29],"Advanced Solid Tumor","Solid Tumors","MTAP-deleted Solid Tumors",[125,66],"MTAP-del","2026-02-10",{"date":128,"type":36},"2026-02-13",{"date":130,"type":36},"2025-08-26",{"date":132,"type":20},"2028-03",{"name":134,"class":82},"PharmaEngine"]