[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Debiopharm International SA\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":142},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,42,64,92,120],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100595693","phase-1-a-first-in-human-study-to-evaluate-safety-tolerability-and-pharmacokinetics-of-single-and-multiple-oral-doses-of-debio-1453p-in-healthy-adults-100595693",false,"NCT07035769","A First-in-Human Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Single and Multiple Oral Doses of Debio 1453P in Healthy Adults","A Phase 1, First-in-human, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Oral Doses of Debio 1453P in Healthy Adults","Inclusion Criteria\n\n1. Signed and dated written informed consent obtained before undertaking any trial-specific procedures.\n2. Be within the age range of 18 to 55 years, inclusive, at the time of screening.\n3. Have a body mass index (BMI) ≥18.5 and ≤30.0 kg\u002Fm\\^2.\n\nExclusion criteria\n\n1. History and\u002For physical examination evidence of any clinically significant disease or disorder, such as cardiovascular, pulmonary, renal, hepatic, neurological, gastrointestinal, endocrine, immunological, psychiatric or mental disease or disorder, or mental or legal incapacitation, which, in the opinion of the Investigator, may either put the participant at risk for taking part in the trial, influence the results of the trial, influence the participant's ability to take part in the trial.\n2. Any medication (including vaccines, over the counter (OTC) and\u002For prescription medication, dietary supplements, nutraceuticals, vitamins and\u002For herbal supplements, and hormonal replacement therapy for postmenopausal participants) for 2 weeks or 5 half-lives of the drug, whichever is longer, prior to first administration of trial drug (except occasional paracetamol (maximum dose of 2 g\u002Fday and maximum of 10 g\u002F2 weeks).\n3. History of chronic drug or alcohol abuse (defined as an average intake of more than 21 units of alcohol per week for males and 14 for females. 1 unit of alcohol equals approximately 250 mL of beer, 100 mL of wine, or 35 mL of spirits) in the last 2 years.",true,"ALL","18 Years","55 Years",{"count":21,"type":22},88,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","The main purpose of this study is to evaluate the safety, tolerability and pharmacokinetics (PK) of Debio 1453P compared to placebo across different dose levels in healthy adults after single and repeated oral dosing.",[28],"Healthy Participants","RECRUITING","2026-06-22",{"date":32,"type":33},"2026-06-23","ACTUAL",{"date":35,"type":33},"2025-06-18",{"date":37,"type":22},"2026-11",{"name":39,"class":40},"Debiopharm International SA","INDUSTRY",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":17,"minAge":50,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":23,"phases":53,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":57,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":63},"100428178","phase-1-study-of-lunresertib-alone-or-in-combination-with-rp-3500-or-debio-0123-in-patients-with-advanced-solid-tumors-100428178","NCT04855656","Study of Lunresertib Alone or in Combination With RP-3500 or Debio 0123 in Patients With Advanced Solid Tumors","Phase 1\u002F1b Study of the Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Clinical Activity of Lunresertib Alone or in Combination With RP-3500 or Debio 0123 in Patients With Advanced Solid Tumors","MYTHIC","Inclusion Criteria:\n\n* Male or female and ≥12 years-of-age at the time of informed consent.\n* Lansky performance status ≥50% for patients ≤16 years of age, or ECOG score of 0, 1, (or 2 for module 1) for patients \\>16 years of age.\n* Locally advanced or metastatic resistant or refractory solid tumors.\n* Patients \\\u003C18 years of age must weigh at least 40 kg.\n* Submission of available tumor tissue at screening or willingness to have a biopsy performed if safe and feasible\n* Next generation sequencing (NGS) report obtained in a CLIA-certified or equivalent laboratory demonstrating eligible tumor biomarker.\n* CCNE1 amplification (non-equivocal) as determined by either a tumor or plasma NGS test, or FISH\n* FBXW7 deleterious mutations identified by either a tumor or plasma NGS test\n* PPP2R1A deleterious mutations identified by either a tumor or plasma NGS test\n* Measurable disease as per RECIST v1.1. For certain modules, patients with prostate cancer or ovarian cancer that have non-measurable disease but have elevated tumor markers (PSA or CA-125, respectively) can also be eligible\n* Ability to swallow and retain oral medications.\n* Acceptable hematologic and organ function at screening.\n* Negative pregnancy test (serum) for women of childbearing potential (WOCBP) at Screening.\n* Resolution of all toxicities of prior therapy or surgical procedures.\n* Any prior radiation must have been completed at least 7 days prior to the start of study drugs, and patients must have recovered from any acute adverse effects prior to the start of study treatment.\n\nExclusion Criteria:\n\n* Chemotherapy or small molecule antineoplastic agent given within 21 days or \\\u003C5 half-lives, whichever is shorter, prior to first dose of study drug.\n* History or current condition, therapy, or laboratory abnormality that might confound the study results or interfere with the patient's participation for the full duration of the study treatment.\n* Patients who are pregnant or breastfeeding.\n* Life-threatening illness, medical condition, active uncontrolled infection, or organ system dysfunction or other reasons which, in the investigator's opinion, could compromise the participating patient's safety.\n* Major surgery within 4 weeks prior to first dose of lunresertib.\n* Uncontrolled, symptomatic brain metastases.\n* Uncontrolled hypertension.\n* Certain prior anti-cancer therapy\n* Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol and\u002For follow-up procedures outlined in the protocol.","12 Years",{"count":52,"type":22},464,[25],"The primary purpose of this study is to assess the safety and tolerability of lunresertib alone and in combination with RP-3500 or in combination with Debio 0123 in patients with eligible advanced solid tumors, determine the maximum tolerated dose (MTD) and assess preliminary anti-tumor activity.",[56],"Advanced Solid Tumor",{"date":32,"type":33},{"date":59,"type":33},"2021-04-30",{"date":61,"type":22},"2028-06",{"name":39,"class":40},22,{"id":65,"slug":66,"hasResults":11,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":72,"targetDuration":4,"studyType":23,"phases":74,"briefSummary":76,"conditions":77,"keywords":79,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},"100587610","phase-3-a-study-to-assess-the-efficacy-and-safety-of-debio-4126-in-participants-with-acromegaly-previously-treated-with-somatostatin-analogs-100587610","NCT06930625","A Study to Assess the Efficacy and Safety of Debio 4126 in Participants With Acromegaly Previously Treated With Somatostatin Analogs","A Phase 3 Randomized 3-arm Trial (Double-blind Debio 4126, Placebo Control, and Open-label Debio 4126), to Assess the Efficacy and Safety of Debio 4126, a 12-week Octreotide Formulation, in Patients With Acromegaly Previously Treated With Somatostatin Analogs","OXTEND™-03","Inclusion criteria\n\n1. Patients ≥18 years of age\n2. Patients who are receiving octreotide or lanreotide monotherapy for acromegaly for at least 6 months, at a stable dose for the last 12 weeks.\n3. IGF-1 at screening ≤1x ULN\n4. Acromegaly diagnosis, defined as per protocol\n5. Adequate bone marrow, hepatic and renal function\n6. To enter Period 2 (Arms A and B): IGF-1 ≤1x ULN at Week 34, or up to Week 48 when treated with rescue medication\n7. Other protocol-defined criteria apply\n\nExclusion criteria\n\n1. Compression of optic chiasm causing visual defects\n2. Symptomatic cholelithiasis or bile duct dilatation\n3. Planned cholecystectomy during the trial duration\n4. Acute or chronic pancreatitis\n5. Pituitary radiotherapy\n6. Uncontrolled hypothyroidism\n7. Uncontrolled diabetes\n8. Pituitary surgery within 6 months before screening or planned on trial\n9. Treatment with pasireotide within 6 months prior to screening, pegvisomant or dopamine agonists within 3 months prior to screening\n10. Recent or ongoing cardiovascular or thromboembolic diseases including heart failure, myocardial infarction, stroke, certain arrythmias, pulmonary embolism\n11. Other protocol-defined criteria apply",{"count":73,"type":22},119,[75],"PHASE3","The primary purpose of this study is to assess the effect of Debio 4126 in the maintenance of the levels of insulin-like growth factor 1 (IGF-1) ≤1x upper limit of normal (ULN) in the double-blind period (Period 1) in comparison to placebo at week 36.",[78],"Acromegaly",[80,81,82,83],"IGF-1","Growth hormone","Pituitary gland","Gigantism","2026-06-21",{"date":32,"type":33},{"date":87,"type":33},"2025-11-26",{"date":89,"type":22},"2029-03",{"name":39,"class":40},72,{"id":93,"slug":94,"hasResults":11,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":4,"eligibilityCriteria":98,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":99,"targetDuration":4,"studyType":23,"phases":101,"briefSummary":103,"conditions":104,"keywords":107,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},"100498096","phase-1-a-study-of-debio-0123-in-combination-with-temozolomide-in-adult-participants-with-recurrent-or-progressive-glioblastoma-and-of-debio-0123-in-combination-with-temozolomide-and-radiotherapy-in-adult-participants-with-newly-diagnosed-glioblastoma-100498096","NCT05765812","A Study of Debio 0123 in Combination With Temozolomide in Adult Participants With Recurrent or Progressive Glioblastoma and of Debio 0123 in Combination With Temozolomide and Radiotherapy in Adult Participants With Newly Diagnosed Glioblastoma","A Phase 1\u002F2 Open-label Study of Debio 0123 in Combination With Temozolomide in Adult Participants With Recurrent or Progressive Glioblastoma and of Debio 0123 in Combination With Temozolomide and Radiotherapy in Adult Participants With Newly Diagnosed Glioblastoma","Screening Inclusion Criteria for Phase 1 and Phase 2:\n\n* Signed written informed consent approved before undertaking any study-specific procedures.\n* Age ≥18 years of age.\n* Willing to provide archived or fresh tumor sample, if available. Receipt of tumor sample is not required for the start of study treatment.\n* Adequate bone marrow, hepatic, and renal function.\n* Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.\n* Willing to practice highly effective methods of contraception.\n* Life expectancy of at least 3 months in the best judgment of the Investigator.\n* Measurable or non-measurable disease as per RANO criteria by gadolinium (Gd)-based contrast-enhanced brain magnetic resonance imaging (MRI).\n* Participants receiving corticosteroids must be on a stable or decreasing dose of ≤4 mg daily dexamethasone (or ≤25 mg prednisone) for the 7 days prior to the start of study treatment.\n* Participants with seizures must be adequately controlled on a stable regimen of anti-epileptic drugs.\n\nAdditional specific inclusion criteria for Phase 1 and Phase 2:\n\n• A maximum of 1 \\[for Phase 1 (Dose Expansion) and phase 2\\] or 2 (Phase 1 Arm A) prior treatment lines of which first-line must be treatment with TMZ-based chemoradiotherapy (TMZ concomitantly with RT).\n\nNote: Only 1 prior line of systemic therapy is allowed; combination therapy with TMZ and RT with or without subsequent TMZ maintenance treatment is considered as 1 systemic line. Prior surgery, radiation, or localized delivery of therapeutic agents (i.e., carmustine-containing wafers \\[GLIADEL®\\]) for first recurrence is allowed.\n\n* Documented disease recurrence or progression by diagnostic biopsy or Gd-based contrast-enhanced brain MRI as per RANO criteria.\n* KPS ≥60.\n\nAdditional specific inclusion criteria for Phase 1 Arm A:\n\n* Participants must have one of the following histopathologically proven diagnoses (WHO 2021):\n* GBM Isocitrate dehydrogenase (IDH)-wildtype Grade 4 which may include secondary GBMs (i.e., those that progress from low-grade gliomas).\n* Astrocytoma, IDH-mutant, Grade 3\n\nAdditional specific inclusion criteria for Phase 1 Arm B and C:\n\n* Participants must have a new, histopathologically proven diagnosis of GBM, IDH-wildtype, Grade 4 (based on WHO 2021), which may include secondary GBMs (i.e., those that progress from low-grade gliomas) if the prior treatment included surgery only.\n* KPS ≥70.\n\nAdditional specific inclusion criteria for Phase 1 dose expansion and Phase 2:\n\n• Participants must have a histopathologically proven diagnosis of GBM, IDH-wildtype Grade 4 WHO 2021\n\nAdditional specific exclusion criteria for Phase 1 Arm A • Prior treatment with more than 2 lines of therapy for GBM, IDH-wildtype, Grade 4, or for astrocytoma, IDH-mutant, Grade 3\n\nAdditional specific exclusion criteria for Phase 1 and Phase 2\n\n* Known contraindication to undergoing for Gd-based, contrast-enhanced MRI.\n* Any anticancer treatment, monoclonal antibodies\u002Fbiologics, investigational treatment, or RT with curative intent within 28 days prior to starting study treatment.\n* Hypersensitivity to Debio 0123, TMZ, dacarbazine, or any of the excipients found in the formulation for Debio 0123 or TMZ.\n* Prior exposure to any WEE1 inhibitor.\n* History of other malignancies requiring active treatment in the last 2 years prior to the first dose of study treatment except for superficial bladder cancers, adequately treated low-risk prostate cancer under active surveillance, ductal carcinoma in situ or other carcinomas in situ, and non-melanoma skin cancers (basal cell\u002Fsquamous cell skin cancer) that have been treated with curative intent.\n* Left ventricular ejection fraction (LVEF) below 55%.\n\nAdditional specific exclusion criteria for Phase 1 Arm B and C:\n\n* Prior radiation, chemotherapy, biological therapy, interstitial brachytherapy, implanted chemotherapy, therapeutics delivered by local injection or convection-enhanced delivery for GBM.\n* Prior therapy that would result in an overlap of the radiation fields.\n\nAdditional specific exclusion criteria for Phase 1 dose expansion and Phase 2\n\n• Prior treatment with more than 1 line of systemic therapy for GBM, IDH-wildtype, Grade 4 (based on WHO 2021). Combination therapy with TMZ and RT with or without subsequent TMZ maintenance treatment is considered as 1 systemic line.\n\n\\[Note: Other inclusion\u002Fexclusion criteria mentioned in the protocol may apply.\\]",{"count":100,"type":22},116,[25,102],"PHASE2","The primary purpose of the Phase 1 (Dose Escalation) of this study is to identify the dose-limiting toxicities (DLTs) of Debio 0123 combined with temozolomide (TMZ) (Arm A) and with TMZ and radiotherapy (RT) (Arms B and C) and to characterize the safety and tolerability of these combinations in adult participants with glioblastoma (GBM). Arm B which was previously added to the protocol, has been permanently halted per the safety monitoring committees' decision on the safety findings of this arm.\n\nThe primary purpose of Phase 1 (Dose expansion) of the study is to assess the doses studied under Phase 1 (Dose Escalation) Arm A and identify the recommended dose (RD) for further development.\n\nThe Phase 2 will start once the RD Phase 1 has been defined. The primary objective of Phase 2 is to assess the efficacy of Debio 0123 at the RD for further development in combination with TMZ, compared to the standard of care (SOC) in adult participants with GBM.",[105,106],"Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype","Astrocytoma, Grade III",[108,109,110],"WEE1 inhibitor","Glioblastoma, IDH-wildtype, Grade 4, World Health Organization (WHO) 2021","Astrocytoma, IDH-mutant, Grade 3, WHO 2021","2026-06-11",{"date":113,"type":33},"2026-06-12",{"date":115,"type":33},"2023-05-15",{"date":117,"type":22},"2028-09",{"name":39,"class":40},16,{"id":121,"slug":122,"hasResults":11,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":4,"eligibilityCriteria":126,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":127,"targetDuration":4,"studyType":23,"phases":129,"briefSummary":130,"conditions":131,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":141},"100590593","phase-1-a-study-to-assess-the-safety-tolerability-and-antileukemic-activity-of-debio-1562m-in-participants-with-acute-myeloid-leukemia-aml-100590593","NCT06969430","A Study to Assess the Safety, Tolerability, and Antileukemic Activity of Debio 1562M in Participants With Acute Myeloid Leukemia (AML)","A Phase 1\u002F2, First-in-human, Multicenter, Open-label Trial Evaluating the Safety, Tolerability, and Antileukemic Activity of Debio 1562M in Participants With Acute Myeloid Leukemia (AML)","Inclusion Criteria:\n\n* For Phase 1-Dose escalation: Relapsed\u002Frefractory (R\u002FR) AML (excluding acute promyelocytic leukemia) based on World Health Organization (WHO) Classification 2022 and relapsed\u002Frefractory higher-risk myelodysplastic syndrome (R\u002FR HR -MDS) (includes high- and very high-risk MDS) as confirmed by the Revised International Prognostic Scoring System (IPSS-R) for whom no standard therapy of proven benefit is available.\n* For Phase1-Dose optimization and Phase 2: R\u002FR AML (excluding acute promyelocytic leukemia) based on world health organization (WHO) classification 2022 for whom no standard therapy of proven benefit is available.\n* Eastern Cooperative Oncology Group performance (ECOG PS) status ≤2.\n* Previous treatment-related toxicities must be resolved to ≤Grade 1 (excluding alopecia).\n* Individuals with prior autologous or allogeneic bone marrow (BM) transplant are eligible.\n* Prior allogeneic transplant must meet the following conditions: the transplant must have been performed more than 120 days before the first administration of Debio 1562M, the participant must not have ≥Grade 1 active graft versus host disease (GvHD) at the time of trial treatment start and must be off all immunosuppression for at least 2 weeks prior to starting treatment with Debio 1562M. Steroid use \\[equivalent to ≤20 milligrams (mg) prednisone\\] before and during the trial is allowed as long as this is not being used as post-transplant immunosuppression or graft versus host disease (GVHD) directed therapy.\n* Adequate renal and hepatic function defined as:\n\n  1. Estimated glomerular filtration rate (eGFR) ≥60 milliliter per minute (mL\u002Fmin) based on the chronic kidney disease-Epidemiology Collaboration based on creatinine (CKD-EPIcr) 2021 equation.\n  2. Aspartate transaminase (AST) and alanine aminotransferase (ALT) ≤3 × upper limit of normal (ULN).\n  3. Serum total bilirubin level ≤1.5× ULN (for participants with Gilbert's syndrome or chronic blood transfusions, total bilirubin ≤3.0× ULN).\n\nExclusion criteria:\n\n* Any prior exposure to cluster of differentiation (CD) 37 targeting agents.\n* Clinically active infection including known active hepatitis B or C, human immunodeficiency virus infection, or cytomegalovirus or any other known concurrent infectious disease that, in the judgment of the Investigator, would make a participant inappropriate for enrollment into this trial (retesting not required).\n* Clinically significant cardiac dysfunction within 6 months before enrollment including New York Heart Association Class III or IV heart failure, uncontrolled angina, myocardial infraction, severe uncontrolled ventricular arrhythmias, QT interval corrected for HR according to Fridericia's formula (QTcF) \\>470 ms.\n* Clinically significant and active cardiopulmonary disease.\n* Other malignancies, except of:\n\n  1. Hematologic malignancies other than those being investigated for which individuals are not on active antineoplastic therapy\n  2. Nonhematologic malignancies in remission and for which individuals must have completed all antineoplastic therapy at least 6 months before trial treatment start and all treatment-related toxicities must have resolved to ≤Grade 1.\n* Evidence for active central nervous system (CNS) leukemia involvement. If the participant has a prior history of CNS AML, the participant must have at least 2 negative cerebrospinal fluid (CSF) analyses and either a magnetic resonance imaging (MRI) or computed tomography (CT) (if MRI is not feasible) of the brain demonstrating no evidence of CNS disease.\n* Evidence of peripheral neuropathy Grade ≥2.\n* History of hypersensitivity to Debio 1562M (including its components), or any of its excipients.\n* Treatment with any antileukemic therapy including chemotherapy, immunotherapy, radiotherapy, hormonal, biologic, or any investigational agent within 14 days or within 5 half-lives of the investigational treatment prior to first dose of trial treatment, whichever is shorter. Hydroxyurea may be given prior to and after trial treatment start for control of leukocytosis.\n* Major surgery within 4 weeks prior to the start of treatment, or participant who have not recovered from side effects of the surgery.\n* Pregnancy or breastfeeding.\n\nNote: Other Inclusion\u002FExclusion criteria may apply.",{"count":128,"type":22},134,[25,102],"The primary purpose of Phase 1 is to assess the doses studied under Phase 1 (Dose Escalation) Arm A and identify the recommended dose (RD) for further development (Dose optimization).\n\nThe primary objective of Phase 2 is to evaluate the antileukemic activity of Debio 1562M.",[132],"Acute Myeloid Leukemia","2026-03-27",{"date":135,"type":33},"2026-03-30",{"date":137,"type":33},"2025-05-30",{"date":139,"type":22},"2031-11",{"name":39,"class":40},7,""]