[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"IDEAYA Biosciences\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":236},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,68,112,140,172,203],{"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":39,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":67},"100614270","phase-1-a-study-of-ide892-as-monotherapy-and-combination-in-mtap-deleted-advanced-solid-tumors-100614270",false,"NCT07277413","A Study of IDE892 as Monotherapy and Combination in MTAP-deleted Advanced Solid Tumors","A Multicenter Study Evaluating the Safety, Efficacy, and Pharmacokinetics of IDE892 as Monotherapy and Combination Therapy in Participants With MTAP-Deleted Advanced Solid Tumors","Inclusion Criteria:\n\n* Are ≥ 18 years of age (or the minimum age of consent in accordance with local regulations) at the time of signing the ICF.\n* Have a histologically confirmed diagnosis of a locally advanced recurrent or metastatic solid tumor type of interest with MTAP deletion (for dose escalation: mesothelioma \\[pleural or peritoneal\\], gastroesophageal cancers \\[squamous and adenocarcinoma of esophagus, gastric adenocarcinoma, gastroesophageal junction cancers\\], pancreatic adenocarcinoma and biliary tract carcinomas (intrahepatic and extrahepatic cholangiocarcinoma, and gallbladder cancer), NSCLC \\[adenocarcinoma, squamous cell carcinoma, and adeno-squamous\\] or UC \\[including mixed urothelial-squamous histology\\]; for dose expansion: NSCLC that has progressed on at least one prior line of treatment and for which additional effective standard therapy is not available or for which the participant is not a candidate due to intolerance).\n* Are willing and able to provide blood\u002Ftumor tissue samples for biomarker testing. An archival tumor tissue specimen must be provided for central confirmation of MTAP loss.\n* Must be willing and able to provide the blood\u002Fserum\u002Fplasma samples\n* Have evidence of homozygous loss of MTAP or MTAP deletion (pre-screening available after signing pre-screening ICF)\n* Have at least 1 measurable lesion according to RECIST version 1.1\n* Have Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1\n* Have life expectancy \\> 3 months\n* Have adequate bone marrow and organ function\n* Able to swallow and retain orally administered study drug\u002FIMP.\n* Are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures\n* Male and female: willing to use contraception\n\nExclusion Criteria:\n\n* Known symptomatic brain metastases requiring supraphysiologic doses of systemic corticosteroids\n* Have a known primary central nervous system (CNS) malignancy\n* Have had other malignancies within 2 years prior to the first dose, with some exceptions\n* Impaired cardiac function or clinically significant cardiac diseases\n* Have presence of uncontrolled pleural, peritoneal, or pericardial effusion within 2 weeks before the first study dose, requiring recurrent drainage procedures or an indwelling drainage catheter\n* Have a history of severe infections within 4 weeks prior to the start of study treatment\n* Hypertension (e.g., \\> 150\u002F100 mmHg) that cannot be controlled by medications despite optimal medical therapy\n* Other acute or chronic medical or psychiatric condition\n* Have a history of immunodeficiency, with a positive human immunodeficiency virus(HIV) test at screening\n* Known or suspected viral hepatitis with a positive test at screening\n* Had an adverse reaction to a previous antitumor treatment that has not recovered to CTCAE Grade ≤ 1\n* Have received chemotherapy within 4 weeks of the first dose of IMP; immunotherapy or biologic targeted antitumor treatments within 2 weeks before the first dose of IMP; small molecule inhibitors within 2 weeks before the first dose of IMP, or other investigational products within 4 weeks\n* Current radiation-related toxicity or radiation therapy within 2 weeks before the first dose of IMP\n* Administration of any of the following within 2 weeks before the first dose of IDE892 as a monotherapy: Strong inhibitors or inducers of cytochrome P450, Strong inhibitors of P-glycoprotein, Narrow therapeutic index and sensitive substrates of multidrug and toxin extrusion (MATE)1 and MATE2-K, Narrow therapeutic index and sensitive substrates of P-gp and breast cancer resistance protein\n* Administration of any of the following within 2 weeks before the first dose of IDE892: Strong inhibitors or inducers of CYP3A4\u002F5, Strong inhibitors of P-gp and\u002For BCRP, Narrow therapeutic index and sensitive substrates of MATE1 and MATE2-K, Narrow therapeutic index and sensitive substrates of P-gp and BCRP\n* Use of proton pump inhibitors (PPIs) within 7 days prior to the first dose of IMP or planned use during the study\n* Use of drugs with known risk for QT prolongation within 2 weeks prior to the first dose of IDE892\n* Previous treatment with a Amethionine adenosyltransferase 2A (MAT2A) inhibitor and\u002For Protein arginine N-methyltransferase (PRMT) inhibitor\n* Major surgery within 4 weeks before study entry\n* Prior irradiation to \\> 25% of the bone marrow\n* Known or suspected hypersensitivity to IDE892\n\nDisease-Specific Eligibility Criteria Eligibility Criteria for Participants with NSCLC (All Parts)\n\n* Must have histologically confirmed diagnosis of advanced or metastatic NSCLC that has progressed after prior treatment with platinum chemotherapy and a PD-1\u002FPD-L1 inhibitor (unless contraindicated or participant developed intolerance) in the metastatic setting\n* Treatment with no more than 3 prior lines in the setting of advanced or metastatic disease.\n* If considered standard of care and available, participants whose cancers have proven targetable oncogene alterations must have had disease progression on (unless contraindicated or participant developed intolerance) at least 1 prior line containing appropriate targeted therapy.\n\nEligibility Criteria for Participants with Urothelial Cancer (Bladder and Upper Urinary Tract), Mesothelioma (Pleural or Peritoneal), Pancreatic Adenocarcinoma or Biliary Tract Carcinomas (Intrahepatic and Extrahepatic Cholangiocarcinoma, and Gallbladder Cancer) (Parts 1 and 3)\n\n* Must have histologically confirmed diagnosis of advanced or metastatic UC, mesothelioma, gastroesophageal cancer or pancreatic and biliary tract tumors\n* Must have progressed following at least 1 prior line of therapy\n* Treatment with no more than 3 prior lines in the setting of advanced or metastatic disease","ALL","18 Years",{"count":19,"type":20},260,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This is a multicenter clinical study to evaluate the safety, efficacy, and Pharmacokinetics (PK) of IDE892 as monotherapy and in combination with other agents including IDE397 in participants with methylthioadenosine phosphorylase (MTAP)-deleted advanced solid tumors within indications of interest.",[26,27,28,29,30,31,32,33,34,35,36,37,38],"NSCLC Adenocarcinoma","Gastroesophageal Cancer (GC)","Gastric Adenocarcinoma","Adenocarcinoma of Esophagus","Squamous Cell Car. - Esophagus","Urothelial Carcinoma (UC)","Bladder Cancer","Mesothelioma","Pleural Mesothelioma","Peritoneal Mesothelioma","Non-Small Cell Lung Cancer NSCLC","Pancreatic Cancer","Biliary Tract Carcinoma",[40,41,42,43,44,45,46,47,48,49,50,51,52,53,54],"MTAP deletion","MTAP loss","MTAP-deficient tumors","homozygous MTAP loss","IDE892","IDE397","MAT2A inhibitor","PRMT5","advanced solid tumors","metastatic cancer","recurrent cancer","dose escalation","dose expansion","phase 1 clinical trial","ctDNA","RECRUITING","2026-06-19",{"date":58,"type":59},"2026-06-23","ACTUAL",{"date":61,"type":59},"2026-03-04",{"date":63,"type":20},"2028-04-30",{"name":65,"class":66},"IDEAYA Biosciences","INDUSTRY",14,{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":75,"targetDuration":4,"studyType":21,"phases":77,"briefSummary":78,"conditions":79,"keywords":88,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},"100631678","phase-1-a-study-of-ide034-in-adult-participants-with-locally-advancedmetastatic-solid-tumors-types-100631678","NCT07503808","A Study of IDE034 in Adult Participants With Locally Advanced\u002FMetastatic Solid Tumors Types","An Open-Label, Multicenter Study Evaluating the Safety, Efficacy, and Pharmacokinetics of IDE034 in Adult Participants With Locally Advanced\u002FMetastatic Solid Tumors","Inclusion Criteria:\n\n1. Participant must be at least 18 years of age or the age of maturity per local regulations\n2. Participants with advanced recurrent or metastatic solid tumors expressing B7-H3 and PTK7 in the following indications: NSCLC, ESCC, endometrial cancer, HGSOC, HNSCC, TNBC (estrogen receptor, progesterone receptor, and human epidermal growth factor receptor 2 \\[HER2\\] negative), CRC, and CRPC who have radiologically progressed or recurred on at least one line of therapy or is intolerant to additional effective standard therapies.\n3. Archival tissue sample for testing\n4. Measurable disease\n5. Have Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.\n6. Have adequate bone marrow and organ function.\n7. Able to comply with contraceptive\u002Fbarrier requirements\n\nExclusion Criteria:\n\n1. Known symptomatic brain metastases or leptomeningeal metastasis\n2. Known primary CNS malignancy and any other malignancies within 2 years prior to the first dose.\n3. Have uncontrolled tumor-associated pain\n4. Have clinically significant cardiac abnormalities and\u002For cerebrovascular disease (stroke) within 6 months before the first dose\n5. Active uncontrolled infection\n6. Have history of interstitial pneumonitis, current noninfectious pneumonitis requiring steroid therapy; known or suspected interstitial pneumonitis as seen on screening imaging; other moderate to severe lung diseases seriously affecting respiratory function within 3 months before the first dose.\n7. Have history of severe infections within 4 weeks prior to the start of study treatment, including but not limited to bacteremia, severe pneumonia, or other serious infectious complications requiring hospitalization.\n8. Have history of immunodeficiency, with a positive human immunodeficiency virus (HIV) test at screening.\n9. Participants with known or suspected viral hepatitis\n10. Have history of active tuberculosis within 1 year before enrollment\n11. If participants had adverse reactions to previous antitumor treatment that have not recovered to guidelines of CTCAE Grade ≤ 1 and Grade 2 peripheral neurological symptoms\n12. Have received chemotherapy within 3 weeks of first dose of IMP; immunotherapy or biologic targeted antitumor treatments within 3 weeks before the first dose of IMP or other investigational products within 4 weeks of first dose of IMP\n13. Administration of any of the following\n\n    1. Current use or anticipated need for food or drugs that are known strong CYP3A4\u002F5 inhibitors or inducers\n    2. Have prior treatment with B7-H3 or PTK7 antibody-drug conjugate (ADC).\n    3. Have prior treatment with a topoisomerase I inhibitor (TOP1i), including an ADC with a TOP1i payload, within 6 months of first dose of IMP\n    4. Have received radiotherapy within 2 weeks prior to study entry\n    5. Have undergone major surgery or trauma within 4 weeks prior to study entry.\n    6. Have received live attenuated vaccine within 28 days prior to the first dose or are expected to receive live attenuated vaccine during the study treatment.\n    7. Female participants who are pregnant, lactating, or planning to become pregnant during the study period to 7 months after the last dose of IMP.\n    8. Are known to be allergic to any component or excipient of the IMP product or have a history of severe allergic reactions to other monoclonal antibody\u002Ffusion protein drugs.\n    9. Participants with complications in the eye including ulcers in the eye, and severe dry eye",{"count":76,"type":20},150,[23],"This is a Phase 1a\u002F1b, open-label, multicenter dose escalation and dose expansion clinical study to evaluate the safety, PK, immunogenicity and preliminary efficacy of IDE034 in participants with locally advanced\u002Fmetastatic solid tumor types that express B7-H3 and PTK7.",[80,81,82,83,84,85,86,87],"Esophageal Squamous Cell Carcinoma","High Grade Serous Ovarian Cancer","Head and Neck Squamous Cell Carcinoma","Colorectal Cancer","Castration-resistant Prostate Cancer","Non Small Cell Lung Cancer","Endometrium Cancer","Triple Negative Breast Cancer",[80,89,90,82,91,92,93,83,94,84,95,96,97,98,99,100,101,102],"ESCC","Endometrial Cancer","HNSCC","Triple-negative Breast Cancer","TNBC","CRC","CRPC","Non-small Cell Lung Cancer","NSCLC","High-grade Serous Ovarian Cancer","HGSOC","Advanced, Metastic Solid Tumors","B7-H3 (CD276) and Protein Tyrosine Kinase 7 (PTK7)","IDE034","2026-06-16",{"date":105,"type":59},"2026-06-18",{"date":107,"type":59},"2026-02-24",{"date":109,"type":20},"2027-07-30",{"name":65,"class":66},15,{"id":113,"slug":114,"hasResults":11,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":4,"eligibilityCriteria":118,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":119,"enrollmentInfo":120,"targetDuration":4,"studyType":21,"phases":122,"briefSummary":123,"conditions":124,"keywords":129,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":139},"100634506","phase-1-a-study-to-investigate-the-safety-pharmacokinetics-and-preliminary-efficacy-of-ide574-therapy-in-adult-participants-with-advanced-solid-tumors-100634506","NCT07540572","A Study to Investigate the Safety, Pharmacokinetics, and Preliminary Efficacy of IDE574 Therapy in Adult Participants With Advanced Solid Tumors","An Open Label, Multicenter Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of IDE574 as Monotherapy in Locally Advanced or Metastatic Solid Tumors and as Combination Therapy With Fulvestrant in Locally Advanced or Metastatic ER+, HER2- Breast Cancer","Inclusion Criteria:\n\nArchival Tissue sample for testing\n\n* Part 1A - Participants with advanced or metastatic ER+, HER2- breast cancer, NSCLC, CRPC, and MSS colorectal adenocarcinoma who have progressed on\u002Fafter at least one line of standard of care therapy or are intolerant to additional effective therapies.\n* Parts 1B, 2A and 2B: Participants with ER+, HER2- breast cancer who have progressed after at least 1 prior line of treatment with an endocrine therapy and a CDK4\u002F6 inhibitor\n* Female participants with ER+, HER2- breast cancer considered to be of childbearing potential (or have tubal ligations only) must be willing to undergo medically induced menopause (Parts 2A and B only)\n* Female participants of nonchildbearing potential with ER+, HER2- breast cancer must meet at least 1 of the following criteria: Age ≥ 60 years or age \\\u003C60 years with absence of menstruation for at least 12 months, or had prior removal of both ovaries\n* Have Eastern Cooperative Oncology Group performance status (ECOG PS) of ≤1.\n* Have adequate bone marrow, renal and liver function.\n* Life expectancy of \\>3 months\n* Able to safely administer and retain orally administered study treatment\n* Able to comply with contraceptive\u002Fbarrier requirements\n\nKey Exclusion Criteria:\n\n* Known symptomatic brain metastases or leptomeningeal metastasis\n* Known primary CNS malignancy and any other malignancies within 2 years prior to the first dose with the exception of adequately treated localized tumor.\n* Have impairment of GI function or GI disease that may significantly alter the absorption of IDE574.\n* Have active liver or biliary disease.\n* Have active, uncontrolled bacterial, fungal, or viral infection\n* Have clinically significant cardiac abnormalities and\u002For blood clotting events within 6 months before the first dose\n* If participants had adverse reactions to previous experimental antitumor treatment that have not recovered to Grade ≤ 1\n* Prior irradiation to \\>25% of the bone marrow.\n* Known or suspected hypersensitivity to IDE574\u002Fexcipients or components (Parts 1 \\& 2) or fulvestrant\u002Fexcipients or components (Part 2 only)","99 Years",{"count":121,"type":20},160,[23],"IDE574 is a synthetically manufactured small molecule inhibitor that co-targets the lysine acetyltransferase enzymes KAT6 and KAT7.\n\nThe purpose of this study is to evaluate the safety, preliminary efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of IDE574 as monotherapy in participants with locally advanced or metastatic solid tumors and as combination therapy with fulvestrant in participants with advanced or metastatic ER+, HER2- breast cancer.",[125,126,127,128],"ER+, HER 2- Breast Cancer","Non-small Cell Lung Cancer (NSCLC)","Castration-resistant Prostate Cancer (CRPC)","Microsatellite Stable (MSS) Colorectal Carcinoma",[125,126,127,128,130,131],"KAT6A\u002FB","KAT7","2026-06-12",{"date":103,"type":59},{"date":135,"type":59},"2026-03-17",{"date":137,"type":20},"2030-06-30",{"name":65,"class":66},11,{"id":141,"slug":142,"hasResults":11,"nctId":143,"briefTitle":144,"officialTitle":145,"acronym":4,"eligibilityCriteria":146,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":147,"targetDuration":4,"studyType":21,"phases":149,"briefSummary":151,"conditions":152,"keywords":156,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":111},"100358462","phase-1-study-of-ide196-in-patients-with-solid-tumors-harboring-gnaq11-mutations-or-prkc-fusions-100358462","NCT03947385","Study of IDE196 in Patients With Solid Tumors Harboring GNAQ\u002F11 Mutations or PRKC Fusions","A Phase 1\u002F2 Study of IDE196 in Patients With Solid Tumors Harboring GNAQ\u002F11 Mutations or PRKC Fusions","Inclusion Criteria:\n\n* Patient must be ≥18 years of age and able to provide written informed consent\n* Diagnosis of the following:\n\n  o MUM: Uveal melanoma with histological or cytological confirmed metastatic disease. Metastatic disease may be treatment naïve or have progressed on or after most recent therapy. If the most recent therapy was an immune-oncology agent, PD must be confirmed.\n\n  \\- If a patient is treatment naïve and human leukocyte antigen (HLA)-A\\*02:01 positive\\*\\*\\*, documentation is required to provide rationale why treatment with tebentafusp is not the ideal firstline treatment approach or of the patient's intolerance to tebentafusp.\n\n  \\*\\*\\*To be enrolled in the HLA-A\\*02:01 positive cohort, HLA status must be documented by test results from a CAP\u002FCLIA-certified laboratory.\n* Measurable disease per RECIST v1.1\n* Eastern Cooperative Oncology Group ≤1 and expected life expectancy of \\> 3 months\n* Adequate organ function at screening\n* Adequate contraceptive measures for non-sterilized male and female patients of childbearing potential\n\nCrizotinib Combination Additional Inclusion Criteria:\n\n* Prior chemotherapy other therapies as applicable or major surgeries must have been completed at least 4 weeks prior to initiation of crizotinib\n* Patients with preexisting peripheral neuropathy can be included if it is Grade 1 or lower, prior to initiation of crizotinib Biopsy-eligible patients\n* Accessible lesion(s) that permit a total of at least two biopsies without unacceptable risk of a significant procedural complication.\n\nExclusion Criteria:\n\n* Previous treatment with a PKC inhibitor\n* Known MSI-H\u002FdMMR tumors who have not previously received immune checkpoint inhibitors\n* Known symptomatic brain metastases\n* Adverse events from prior anti-cancer therapy that have not resolved\n* Known acquired immunodeficiency syndrome (AIDS)-related illness, hepatitis B virus, or hepatitis C virus\n* Active infection requiring ongoing therapy\n* Recent surgery or radiotherapy\n* Prior gastrectomy or upper bowel removal or any other gastrointestinal disorder or defect\n* Females who are pregnant or breastfeeding\n* Impaired cardiac function\n* Treatment with prohibited medications that cannot be discontinued prior to study entry\n* For patients receiving IDE196 powder-in-capsule (PIC) formulation or crizotinib, allergy to mammalian meat products and gelatin\n\nCrizotinib Combination Additional Exclusion Criteria:\n\n* Prior therapy directly targeting ALK, MET, or ROS1\n* Spinal cord compression\n* History of pneumonitis or interstitial lung disease\n* History of syncope\n* History of thromboembolic or cerebrovascular events ≤12 weeks prior to first dose of study treatment\n\nPK Substudy (optional) with Pravastatin Additional Exclusion Criteria:\n\n* Taken any dose of statin or inhibitor of organic anion transporting polypeptide within 7 days prior to enrollment in the study and cannot refrain from them through C2D1\n* Taken drugs that interfere with the absorption, metabolism, or elimination of pravastatin\n* Any contraindication associated to the use of statins or hypersensitivity component of pravastatin\n* Active liver disease\n\nDDI Cocktail Substudy Additional Exclusion Criteria:\n\n* Treatment with bupropion, repaglinide, flurbiprofen, omeprazole, esomeprazole, midazolam, and dabigatran etexilate within 7 days prior to Cycle 1 Day -1.\n* Intake of vitamin supplements containing Vitamin B6 (pyridoxine), grapefruit\u002Fgrapefruit juice, or Seville orange juice within 7 days prior to Cycle 1 Day -1.\n* Intake of any strong or moderate inhibitor of CYP2B6, CYP2CI, CYP2C9, CYP2C10 and OAT3 is prohibited within 7 days or within 5 half-lives, whichever is longer, of Cycle 1 Day -1.\n* Moderate and strong inhibitors of CYP2A4\u002F5 or P-gp are prohibited within 7 days, or within 5 half-lives, whichever is longer, of Cycle 1 Day -1.\n* Intake of strong or moderate inducers of CYP3A4\u002F5, CYP2B6, CYP2C9, CYP2C19, or OAT3 is prohibited during 15 days, or 5 half-lives, whichever is longer, prior to Cycle 1 Day -1.",{"count":148,"type":20},336,[23,150],"PHASE2","This is a Phase 1\u002F2, multi-center, open-label basket study designed to evaluate the safety and anti-tumor activity of IDE196 in patients with solid tumors harboring GNAQ or GNA11 (GNAQ\u002F11) mutations or PRKC fusions, including metastatic uveal melanoma (MUM), cutaneous melanoma, colorectal cancer, and other solid tumors.\n\nPhase 1 (dose escalation - monotherapy) will assess safety, tolerability and pharmacokinetics of IDE196 via standard dose escalation scheme and determine the recommended Phase 2 dose. Safety and anti-tumor activity will be assessed in the Phase 2 (dose expansion) part of the study.\n\nPhase 1 (dose escalation - binimetib combination) will assess safety, tolerability and pharmacokinetics of IDE196 and binimetinib via standard dose escalation scheme and determine the recommended Phase 2 dose. Safety and anti-tumor activity will be assessed in the Phase 2 (dose expansion) part of the study.\n\nPhase 1 (dose escalation - crizotinib combination) will assess safety, tolerability and pharmacokinetics of IDE196 and crizotinib via standard dose escalation scheme and determine the recommended Phase 2 dose. Safety and anti-tumor activity will be assessed in the Phase 2 (dose expansion) part of the study. Evaluation of safety and efficacy across multiple doses may be explored in the dose optimization part of the study.\n\nCrizotinib monotherapy with crossover to combination cohort may be assessed for safety and to show the contribution of each study drug to anti-tumor activity.\n\nAs of Protocol Amendment 10, Phase 1, Phase 2 dose expansion in IDE196 monotherapy, and Phase 2 dose expansion of IDE196 in combination with binimetinib have been fully enrolled. There were no patients enrolled in the crizotinib monotherapy cohorts.",[153,154,83,155],"Metastatic Uveal Melanoma","Cutaneous Melanoma","Other Solid Tumors",[153,157,158,159,160,161,162,163],"Uveal Melanoma","Protein Kinase C","Ophthalmology","Ocular Oncology","Darovasertib","IDE196","Ocular Melanoma","2026-06-04",{"date":166,"type":59},"2026-06-08",{"date":168,"type":59},"2019-06-28",{"date":170,"type":20},"2027-06-15",{"name":65,"class":66},{"id":173,"slug":174,"hasResults":11,"nctId":175,"briefTitle":176,"officialTitle":177,"acronym":4,"eligibilityCriteria":178,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":179,"targetDuration":4,"studyType":21,"phases":181,"briefSummary":183,"conditions":184,"keywords":185,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":195,"startDateStruct":197,"completionDateStruct":199,"leadSponsor":201,"locationsCount":202},"100594111","phase-3-neoadjuvant-darovasertib-in-primary-uveal-melanoma-100594111","NCT07015190","Neoadjuvant Darovasertib in Primary Uveal Melanoma","A Randomized, Phase 3, Open-label Study of Neoadjuvant Darovasertib in Subjects With Primary Non-metastatic Uveal Melanoma (OptimUM-10)","Inclusion Criteria:\n\n* Primary non-metastatic uveal melanoma\n* Able and willing to provide written, informed consent before initiation of any study-related procedures, and in the opinion of the Investigator, to comply with all study requirements\n* ECOG 0 or 1\n* Adequate organ function\n\nExclusion Criteria:\n\n* Previous treatment for UM\n* Evidence of metastatic UM\n* Attributes that necessitate enucleation regardless of response to therapy\n* Evidence of progressive secondary underlying ocular disease that would confound longitudinal VA assessments\n* Presence of a malignant disease other than the one being treated in this study",{"count":180,"type":20},520,[182],"PHASE3","This is a Phase 3, randomized, multi-center, open-label study of neoadjuvant darovasertib in subjects with primary non-metastatic uveal melanoma (OptimUM-10)",[157],[157,186,187,188,161,189,163,190,159,160,191,158,192,193],"Plaque Brachytherapy","Enucleation","Neoadjuvant","IDE 196","Choroidal Melanoma","Melanoma","GNAQ","GNA11","2026-05-01",{"date":196,"type":59},"2026-05-06",{"date":198,"type":59},"2026-01-25",{"date":200,"type":20},"2031-03",{"name":65,"class":66},94,{"id":204,"slug":205,"hasResults":11,"nctId":206,"briefTitle":207,"officialTitle":208,"acronym":4,"eligibilityCriteria":209,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":210,"targetDuration":4,"studyType":21,"phases":212,"briefSummary":213,"conditions":214,"keywords":218,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":227,"lastUpdatePostDateStruct":228,"startDateStruct":230,"completionDateStruct":232,"leadSponsor":234,"locationsCount":235},"100606363","phase-1-a-study-of-ide849-in-patients-with-dll3-expressing-tumors-including-small-cell-lung-cancer-100606363","NCT07174583","A Study of IDE849 in Patients With DLL3 Expressing Tumors Including Small Cell Lung Cancer","A Multicenter Study Evaluating the Safety, Efficacy, and Pharmacokinetics of IDE849 in Patients With DLL3-Expressing Tumors Including Small Cell Lung Cancer","Inclusion Criteria:\n\n1. Are willing to participate in this clinical study, understand the study procedures, and are able to sign the written ICF.\n2. Subjects with histologically or cytologically confirmed extensive-stage SCLC neuroendocrine carcinoma (NEC), and other DLL3+ tumors, are eligible per protocol. Subjects must have radiologically progressed or recurred after previous standard treatment, For SCLC, this includes platinum-based therapy and programmed death-1\u002Fprogrammed death-ligand 1 inhibitors (except for subjects who refuse or are judged by the Investigator to be unsuitable for immunotherapy). No more than 2 lines of previous systemic chemotherapy in any setting and no more than 3 total lines of systemic therapy in the recurrent or metastatic setting will be allowed.\n3. Subjects will be required to provide blood\u002Ftumor tissue samples for biomarker testing.\n4. Have at least 1 measurable lesion according to RECIST version 1.1.\n5. Have Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1.\n6. Have life expectancy \\> 3 months.\n7. Have adequate bone marrow and organ function.\n8. Women of childbearing potential must agree to take highly effective contraceptive measures from signing of consent through 8 months after the last dose of IDE849; men with partners of child-bearing potential must use effective contraception through 5 months after the last dose.\n\nExclusion Criteria:\n\n1. Have mixed SCLC and nonsmall cell lung cancer histology (SCLC with components of large cell neuroendocrine carcinoma are eligible).\n2. Subjects with locally untreated (radiotherapy or surgery) or active central nervous system (CNS) tumor metastasis.\n3. Have had other malignancies within 2 years prior to the first dose, except adequately treated carcinoma in situ (cervical, breast, or other), basal cell or squamous cell skin cancer, localized prostate cancer after curative therapy with no recurrence, or papillary thyroid cancer after curative resection; other prior or concurrent malignancies may be eligible with Medical Monitor review and approval.\n4. Have uncontrolled tumor-associated pain.\n5. Have severe cardiovascular and cerebrovascular disease\n6. Have history of clinically significant bleeding within 3 months before the first study dose.\n7. Have history of interstitial pneumonitis during previous treatment; current noninfectious pneumonitis requiring steroid therapy; known or suspected interstitial pneumonitis as seen on screening imaging; other moderate to severe lung diseases seriously affecting respiratory function within 3 months before the first dose, including, but not limited to, idiopathic pulmonary fibrosis and organizing pneumonia\u002Fobliterative bronchiolitis.\n8. Have history of immunodeficiency, with a positive human immunodeficiency virus (HIV) test.\n9. Subjects with known or suspected viral hepatitis.\n10. Have a history of active tuberculosis within 1 year before enrollment.\n11. For participants enrolling to receive the combination with durvalumab, must not have had any prior Grade 2 or higher myocarditis or any other Grade 3 or higher immune-related AE. If the participant has had a prior immune-related AE, must have recovered to \\\u003C Grade 1\n12. For participants enrolling to receive the combination with IDE161, must not have had prior gastrectomy or upper bowel removal or any other gastrointestinal disorder or defect eg, malabsorption disorder such as Crohn's disease or ulcerative colitis, that would interfere with absorption of IDE161\n13. Have received chemotherapy within 3 weeks of first dose of IMP; immunotherapy or biologic targeted anti-tumor treatments within 2 weeks before the first dose of IMP; for small molecule treatments within 2 weeks before the first dose of the IMP or within 5 half lives of the drug (whichever is longer); other investigational products within 4 weeks or within 5 half-lives of the drug (whichever is longer) unless, in the opinion of the Investigator and Sponsor, the medication will not interfere with the study. Participants who received an immunotherapy agent (eg, PD-1\u002FPD-L1 inhibitor) immediately prior to study enrollment must have documented radiologic disease progression as per the Investigator prior to first dose of IMP\n14. Administration of any of the following:\n\n    * Strong inhibitors or inducers of CYP3A4\n    * Strong inhibitors of CYP2D6\n    * Strong inhibitors of P-gp or BCRP\n    * Use of drugs with a known risk of QT prolongation\n15. For participants enrolling to receive the combination with IDE161:\n\n    * Use of drugs of narrow therapeutic index that are sensitive substrates of MATE2-K, BCRP, and P-gp\n    * Use of known moderate and strong CYP3A4\u002F5 inducers and inhibitors is not permitted\n    * Administration of PPIs\n    * Use of an H2 blocking agent\n    * Use of a local antacid\n    * Use of drugs with a known risk of QT prolongation\n16. Have prior treatment with DLL3 ADC or prior treatment with a topoisomerase I inhibitor including an ADC with a topoisomerase I inhibitor payload.\n17. For participants enrolling to receive the combination with durvalumab, have history of prior intolerance to PD-1\u002FPD-L1 inhibitors\n18. Have received \\> 30 Gy of chest radiotherapy within 12 weeks prior to the first dose of the IMP, \\> 30 Gy of non-chest radiotherapy within 4 weeks prior to the first dose (subjects who have completed radiotherapy for brain metastases within 14 days prior to the first dose can be enrolled and palliative radiotherapy for other sites of ≤ 30 Gy is allowed if completed more than 14 days prior to the first dose).\n19. Have undergone major surgery or experienced significant trauma within 4 weeks prior to the first dose.\n20. Female subjects who are pregnant, lactating, or planning to become pregnant during the study period to 8 months after the last dose of the IMP.",{"count":211,"type":20},208,[23,150],"This is Phase 1\u002F2, multicenter, clinical study to evaluate the safety, efficacy, PK, and immunogenicity of IDE849 in subjects with DLL3-expressing tumors including SCLC.",[215,216,217],"Small-cell Lung Cancer","Neuroendocrine Carcinomas","Solid Tumor Show to Express DLL3",[219,220,221,222,223,216,224,225,226],"IDE849","Small Cell Lung Cancer","SCLC","anti-DLL3 immunoglobulin G1 monoclonal antibody","DLL3","NEC","durvalumab","IDE161","2026-01-21",{"date":229,"type":59},"2026-01-23",{"date":231,"type":59},"2025-10-14",{"date":233,"type":20},"2029-05",{"name":65,"class":66},39,""]