[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100497644":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":19,"locations":28,"responsibleParty":61,"collaborators":11,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":11,"eligibilityCriteria":69,"healthyVolunteers":65,"sex":70,"minAge":71,"maxAge":11,"enrollmentInfo":72,"targetDuration":11,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":88,"overallStatus":31,"whyStopped":11,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Molecure S.A.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"OATD-02","EXPERIMENTAL",null,[13],"Drug: OATD-02",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":11},"DRUG","Boin Design Scheme will be applied for dose escalation. Dose will start with 2.5mg o.d., the desicion about dose escalations will be made based on the occurence of DLT",[9],[20,25],{"name":21,"role":22,"phone":23,"phoneExt":11,"email":24},"Clinical","CONTACT","0048225526724","clinical@molecure.com",{"name":26,"role":22,"phone":23,"phoneExt":11,"email":27},"Molecure SA","contact@molecure.com",[29,43,52],{"facility":30,"status":31,"city":32,"state":33,"zip":34,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":11},"Site","RECRUITING","Bydgoszcz","Kuyavian-Pomeranian Voivodeship","85796","Poland","PL",{"type":38,"coordinates":39},"Point",[40,41],18.00762,53.1235,{"lat":41,"lon":40},{"facility":30,"status":31,"city":44,"state":45,"zip":46,"country":35,"countryCode":36,"cosmosGeoPoint":47,"geoPoint":51,"contacts":11},"Otwock","Masovian Voivodeship","05-400",{"type":38,"coordinates":48},[49,50],21.26129,52.10577,{"lat":50,"lon":49},{"facility":53,"status":31,"city":54,"state":45,"zip":55,"country":35,"countryCode":36,"cosmosGeoPoint":56,"geoPoint":60,"contacts":11},"SIte","Warsaw","01748",{"type":38,"coordinates":57},[58,59],21.01178,52.22977,{"lat":59,"lon":58},{"type":62,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100497644","phase-1-first-in-human-phase-i-study-to-evaluate-safety-tolerability-and-antineoplastic-activity-of-oatd-02-in-patients-with-selected-advanced-andor-metastatic-solid-tumours-100497644",false,"NCT05759923","First-in-human Phase I Study to Evaluate Safety, Tolerability and Antineoplastic Activity of OATD-02 in Patients with Selected Advanced And\u002For Metastatic Solid Tumours","An Open-label, Multicentre, Dose-escalation, First-in-human Phase I Study to Evaluate Safety, Tolerability and Antineoplastic Activity of OATD-02 in Patients with Selected Advanced And\u002For Metastatic Solid Tumours (colorectal Cancer, Ovarian Cancer, Pancreatic Cancer or Renal Cell Carcinoma)","Inclusion Criteria:\n\n1. Capable of understanding and complying with protocol requirements.\n2. Male or female patient aged ≥18 years at Screening.\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n4. Histologically or cytologically confirmed advanced and\u002For metastatic colorectal cancer, renal cell cancer, or pancreatic cancer or recurrent serous ovarian cancer (platinum-resistant\u002Fineligible to receive platinum-based chemotherapy), that either progressed or relapsed after all relevant standard of care cancer therapies (at least 1 line of systemic cancer therapy).\n5. Written informed consent given by the patient before the initiation of any study procedures.\n\nExclusion Criteria:\n\n1. Unable to take oral medications.\n2. Clinically active central nervous system metastases and\u002For carcinomatous meningitis.\n3. Major surgery within 30 days before the first IMP dose.\n4. Pregnant or breastfeeding women.\n5. Known allergy to excipients of the IMP.\n6. Severe, uncontrolled systemic disease which in the opinion of the investigator, would compromise the safety of the patient or the patient's ability to participate in the study.\n7. Participation in another clinical study within 4 weeks before the first IMP dose.","ALL","18 Years",{"count":73,"type":74},40,"ESTIMATED","INTERVENTIONAL",[77],"PHASE1","The goal of this clinical trial is to learn if the OATD-02 administration (orally) in monotherapy is safe and has the pharmacodynamic potential to restore and enhance tumour responses to immunotherapy through increased arginine levels or intrinsic anti-tumour activity in participants with advanced metastatic colorectal cancer, ovarian cancer, renal cancer or pancreatic cancer.",[80,81,82,83,84,85,86,87],"Advanced Ovarian Carcinoma","Advanced Renal Cell Carcinoma","Advanced Pancreatic Carcinoma","Advanced Colorectal Carcinoma","Metastatic Pancreatic Carcinoma","Metastatic Colorectal Carcinoma","Metastatic Renal Cell Carcinoma","Metastatic Ovarian Carcinoma",[89,90,91,92,93],"solid tumors","renal cancer","ovarian cancer","pancreatic cancer","colorectal cancer","2025-02-20",{"date":96,"type":97},"2025-02-24","ACTUAL",{"date":99,"type":97},"2023-01-26",{"date":101,"type":74},"2025-12",{"name":5,"class":6},3]