[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Day One Biopharmaceuticals, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":104},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,47,75],{"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":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100468301","phase-1-a-study-of-emiltatug-ledadotin-emi-le-in-participants-with-solid-tumors-100468301",false,"NCT05377996","A Study of Emiltatug Ledadotin (Emi-Le) in Participants With Solid Tumors","A Phase 1\u002F2, First-in-human, Multicenter Study of Emiltatug Ledadotin (Emi-Le) in Participants With Solid Tumors","Inclusion Criteria:\n\n* Recurrent or advanced solid tumor and has disease\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n* Participants in DES must have at least one measurable disease (target) lesion as defined by RECIST version 1.1.\n* Tumor tissue, either archival or from a fresh tumor biopsy, available for testing or be willing to undergo a minimally invasive tumor biopsy to obtain tumor tissue for local testing, if not medically contraindicated, prior to Cycle 1 Day 1\n* Brain magnetic resonance imaging (MRI) during the Screening period unless obtained within 30 days prior to Screening (based on standard clinical care), if they meet either of the following criteria:\n\n  1. All participants with TNBC\n  2. Participants with a history of brain metastases or with neurologic symptoms or signs suspicious for brain metastases.\n\nExclusion Criteria:\n\n* Prior treatment with an Antibody Drug Conjugate (ADC) containing an auristatin payload. Prior treatment with another ADC containing other payloads is allowed.\n* Major surgery within 28 days of starting study treatment, systemic anticancer therapy within the time period of 28 days or 5 half-lives of the prior therapy before starting study treatment (14 days or 5 half-lives for small molecule targeted therapy), whichever is less, or palliative radiation therapy to the chest within 3 months of starting study treatment or to other anatomic sites within 14 days of starting study treatment.\n* Diagnosis of additional malignancy that required active treatment (including surgery, systemic therapy, and radiation) within 2 years prior to screening, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the breast or of the cervix.\n* Untreated CNS metastases (including new and progressive brain metastases), history of leptomeningeal metastasis or carcinomatous meningitis.\n* Prior B7-H4 targeted treatment.\n* History of cirrhosis, hepatic fibrosis, esophageal or gastric varices, or other clinically significant liver diseases.\n* Current severe, uncontrolled systemic disease (e.g. clinically significant cardiovascular, pulmonary, or metabolic disease) or intercurrent illness that could increase the risk of serious adverse events (SAEs) or interfere with per-protocol evaluations, in the judgment of either the Sponsor or the Investigator.\n* Clinically significant cardiovascular disease\n* Active keratitis (inflammation of the cornea of the eye)","ALL","18 Years",{"count":19,"type":20},360,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","A Study of Emi-Le in Participants with Solid Tumors",[27,28,29,30,31,32,33],"Triple Negative Breast Cancer","Breast Cancer","Endometrial Cancer","Ovarian Cancer","Fallopian Tube Cancer","Primary Peritoneal Cavity Cancer","Adenoid Cystic Carcinoma","RECRUITING","2026-06-24",{"date":37,"type":38},"2026-06-29","ACTUAL",{"date":40,"type":38},"2022-08-15",{"date":42,"type":20},"2027-12",{"name":44,"class":45},"Day One Biopharmaceuticals, Inc.","INDUSTRY",26,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":21,"phases":56,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},"100573930","phase-1-to-evaluate-the-safety-tolerability-pharmacokinetics-and-antitumor-activity-of-day301-in-participants-with-locally-advanced-or-metastatic-solid-tumors-100573930","NCT06752681","To Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of DAY301 in Participants With Locally Advanced or Metastatic Solid Tumors","A Phase 1, Open Label, Multiple Dose, Dose Escalation and Expansion Study to Investigate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of the PTK7-Targeted Antibody-drug Conjugate DAY301 in Patients With Locally Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\n* Histologically or cytologically confirmed diagnosis of advanced or metastatic solid tumors of the following histologies:\n* Ovarian cancer\n* Esophageal squamous cell carcinoma\n* Triple-negative breast cancer\n* Non-small cell lung cancer\n* Small cell lung cancer\n* Head and neck squamous cell carcinoma\n* Gastric\u002Fgastroesophageal junction adenocarcinoma\n* Cervical squamous cell carcinoma\n* Endometrial cancers\n\n(Participants must have been previously treated with standard of care systemic therapy, or for whom no standard therapy is available).\n\n* Availability of tumor tissue sample (either an archival specimen or a fresh biopsy) at screening\n* Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1).\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Adequate organ function.\n\nExclusion Criteria:\n\n* Prior use of PTK7 targeting treatment (Phase 1a) or prior use of PTK7 targeting treatments and\u002For topoisomerase 1 (TOP1) inhibitor-based antibody-drug conjugate (ADC) (Phase 1b).\n* Phase 1b disease-specific exclusion criteria:\n\n  1. Cohort 1: Neuroendocrine tumors or endometrial sarcoma (eg, stromal sarcoma, leiomyosarcoma, or other types of pure sarcomas)\n  2. Cohort 2: Ovarian cancer that progressed \\>6 months after the last dose of platinum-based chemotherapy (platinum-sensitive disease), or disease that did not respond (partial response \\[PR\\] or complete response \\[CR\\]) to or progressed ≤91 days after the last dose of first-line platinum-based chemotherapy (primary platinum-refractory disease)\n  3. Cohort 3: nasopharyngeal primary tumors.\n* History of small bowel obstruction requiring hospitalization within 3 months prior to the first dose of study treatment.\n* Ascites requiring frequent paracentesis (more often than approximately every 4 weeks) for symptomatic management, or new onset within 4 weeks prior to the first dose of study treatment. Patients with an indwelling catheter may be considered eligible, after consultation with the medical monitor.\n* Active or progressing brain metastases or evidence of leptomeningeal disease.\n* Persistent toxicities from previous systemic antineoplastic treatments of Grade \\>1, excluding alopecia and vitiligo.\n* Systemic antineoplastic therapy within five half-lives or 4 weeks, whichever is shorter, prior to first dose of study treatment, including investigational agents.\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":55,"type":20},254,[23],"This is a Phase 1a\u002F1b, open-label, dose escalation and expansion study to evaluate the safety and anti-tumor activity of DAY301, a PTK7-directed antibody-drug conjugate in participants with advanced or metastatic solid tumors. The study comprises of 2 phases: Phase 1a dose escalation where participants will be administered DAY301 at escalating dose levels to assess safety and tolerability, and to determine the maximum tolerated dose (MTD) and\u002For the recommended dose (RD); In Phase 1b dose expansion, DAY301 will be evaluated in dose expansion cohorts.",[59],"Advanced or Metastatic Solid Tumors",[61,62,63,64,65],"Advanced or metastatic solid tumors","Dose Escalation","Dose Expansion","DAY301","PTK7-Targeted Antibody-drug Conjugate","2025-10-08",{"date":68,"type":38},"2025-10-10",{"date":70,"type":38},"2024-11-18",{"date":72,"type":20},"2028-12",{"name":44,"class":45},12,{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":16,"minAge":83,"maxAge":84,"enrollmentInfo":85,"targetDuration":4,"studyType":21,"phases":87,"briefSummary":88,"conditions":89,"keywords":92,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},"100422027","phase-2-a-study-to-evaluate-tovorafenib-in-pediatric-and-young-adult-participants-with-relapsed-or-progressive-low-grade-glioma-and-advance-solid-tumors-100422027","NCT04775485","A Study to Evaluate Tovorafenib in Pediatric and Young Adult Participants With Relapsed or Progressive Low-Grade Glioma and Advance Solid Tumors","FIREFLY-1: A Phase 2, Open-Label, Multicenter Study to Evaluate the Safety and Efficacy of the Oral Pan-RAF Inhibitor DAY101 in Pediatric Patients With RAF-Altered, Recurrent or Progressive Low-Grade Glioma and Advanced Solid Tumors","FIREFLY-1","Inclusion Criteria:\n\n* Low Grade Glioma \\& Low-Grade Glioma Extension: a relapsed or progressive LGG with documented known activating BRAF alteration.\n* Advanced Solid Tumor: locally advanced or metastatic solid tumor with documented known or expected to be activating RAF fusion.\n* Participants must have histopathologic verification of malignancy at either original diagnosis or relapse.\n* Must have received at least one line of prior systemic therapy and have documented evidence of radiographic progression.\n* Must have at least 1 measurable lesion as defined by RANO (Arms 1 \\& 2) or RECIST v1.1 (Arm 3) criteria\n\nExclusion Criteria:\n\n* Participant's tumor has additional previously-known activating molecular alterations.\n* Participant has symptoms of without radiographically recurrent or radiographically progressive disease.\n* Known or suspected diagnosis of neurofibromatosis type 1 (NF-1) via genetic testing or current diagnostic criteria.\n\nOther inclusion\u002Fexclusion criteria as stipulated by protocol may apply","6 Months","25 Years",{"count":86,"type":20},141,[24],"This is a Phase 2, multi center, open-label study to evaluate the safety and efficacy of Type II RAF (tovorafenib) in pediatric participants with low-grade glioma or advanced solid tumors. Qualifying genomic alterations will be identified through molecular assays as routinely performed at Clinical Laboratory Improvement Amendments (CLIA) of 1988 or other similarly certified laboratories prior to enrollment into any of the arms. The study will consist of a screening period, a treatment period, a long-term extension phase, end of treatment (EOT) visit(s), a safety follow-up visit, and long-term follow-up assessments.",[90,91],"Low-grade Glioma","Advanced Solid Tumor",[90,91,81,93,94],"DAY101","Tovorafenib","2025-03-27",{"date":97,"type":38},"2025-04-10",{"date":99,"type":38},"2021-04-22",{"date":101,"type":20},"2027-05-31",{"name":44,"class":45},35,""]