MS202659_0001 DDRIVER

An Open Label, Multicenter, Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic Profile of the PARP1 Inhibitor M9466 Alone or in Combination in Participants With Advanced Solid TumorsThe purpose of this study is to evaluate the safety, tolerability, pharmacokinetic, pharmacodynamic profile of M9466 with and without tuvusertib or an ARPi and early signs of clinical activity of M9466 with tuvusertib in participants with advanced solid tumors. Study details include: Study/Treatment Duration: Participants will be treated until disease progression, death, discontinuation, or End of Study. Visit Frequency: Every week in the first 2 cycles, followed by every 3 weeks in the subsequent cycles. An End of Treatment Visit and Safety Follow-up/Discontinuation Visit are scheduled after the treatment period.

{ "short_title": "MS202659_0001 DDRIVER", "data_mode": "900", "data_mode_number": "000002427", "official_title": "An Open Label, Multicenter, Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic Profile of the PARP1 Inhibitor M9466 Alone or in Combination in Participants With Advanced Solid Tumors", "accrual_state": "running", "therapeutic_value": "therapeutic", "therapieansatz_value": "palliativ", "therapieintervention_value": "neoadjuvant", "therapielinie_value": "first", "ctgov_number": "NCT06421935", "eudract_number": "2024-513492-41", "general_contact_email": "studiensekretariat.gyn@ukdd.de", "general_contact_phone": "+49 351-4584202", "hauptpruefer_dd_name": "Prof. Dr. med. Pauline Wimberger", "description_laie_de": "Eine offene, multizentrische Phase-1-Studie zur Bewertung der Sicherheit, Vertr\u00e4glichkeit und des pharmakokinetischen/pharmakodynamischen Profils des PARP1-Inhibitors M9466 allein oder in Kombination bei Teilnehmern mit fortgeschrittenen soliden Tumoren\r\nZiel dieser Studie ist die Bewertung der Sicherheit, Vertr\u00e4glichkeit, Pharmakokinetik und Pharmakodynamik von M9466 mit und ohne Tuvusertib oder einem ARPi sowie fr\u00fcher klinischer Aktivit\u00e4t von M9466 mit Tuvusertib bei Teilnehmern mit fortgeschrittenen soliden Tumoren. Studiendetails: Studien-/Behandlungsdauer: Die Teilnehmer werden bis zum Fortschreiten der Krankheit, Tod, Abbruch oder Studienende behandelt. Kontrollfrequenz: W\u00f6chentlich in den ersten beiden Zyklen, danach alle drei Wochen in den Folgezyklen. Nach der Behandlungsperiode finden ein Kontrolltermin zum Behandlungsende und eine Sicherheitsnachuntersuchung/ein Abbruchtermin statt.", "description_laie_en": "An Open Label, Multicenter, Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic Profile of the PARP1 Inhibitor M9466 Alone or in Combination in Participants With Advanced Solid TumorsThe purpose of this study is to evaluate the safety, tolerability, pharmacokinetic, pharmacodynamic profile of M9466 with and without tuvusertib or an ARPi and early signs of clinical activity of M9466 with tuvusertib in participants with advanced solid tumors. Study details include: Study/Treatment Duration: Participants will be treated until disease progression, death, discontinuation, or End of Study. Visit Frequency: Every week in the first 2 cycles, followed by every 3 weeks in the subsequent cycles. An End of Treatment Visit and Safety Follow-up/Discontinuation Visit are scheduled after the treatment period.", "description_expert_de": "Eine offene, multizentrische Phase-1-Studie zur Bewertung der Sicherheit, Vertr\u00e4glichkeit und des pharmakokinetischen/pharmakodynamischen Profils des PARP1-Inhibitors M9466 allein oder in Kombination bei Teilnehmern mit fortgeschrittenen soliden Tumoren", "description_expert_en": "An Open Label, Multicenter, Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic Profile of the PARP1 Inhibitor M9466 Alone or in Combination in Participants With Advanced Solid Tumors", "rechtsgrundlage_value": "AMG", "phase_amg_value": "I", "main_cat_id": 3, "sub_cat_id": 15 }