Abbvie M23-385

Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess safety, tolerability, pharmacokinetics and preliminary efficacy of ABBV-706 as a monotherapy and in combination with budigalimab, carboplatin, or cisplatin. ABBV-706 is an investigational drug being developed for the treatment of small cell lung cancer (SCLC), high-grade central nervous system (CNS) tumors and high-grade neuroendocrine carcinomas (NECs). There are multiple treatment arms in this study. Participants will either receive ABBV-706 as a single agent or in combination with budigalimab (another investigational drug), carboplatin or cisplatin at different doses. Approximately 350 adult participants will be enrolled in the study across sites worldwide. In part 1 (dose escalation), ABBV-706 will be intravenously infused in escalating doses as a monotherapy until the maximum tolerated dose (MTD) is determined in participants with SCLC, high-grade

The objective of this study is to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of ABBV-706 as monotherapy and in combination with budigalimab, carboplatin or cisplatin. ABBV-706 is an investigational drug being developed for the treatment of small cell lung cancer (SCLC), high-grade central nervous system (CNS) tumors and high-grade neuroendocrine carcinoma (NEC). There are multiple treatment arms in this trial. Participants will receive ABBV-706 either as a single agent or in combination with budigalimab (another investigational drug), carboplatin or cisplatin at different doses. Approximately 350 adult participants will be enrolled in the study at various sites worldwide. In Part 1 (dose escalation), ABBV-706 will be infused intravenously in increasing doses as monotherapy until the maximum tolerated dose (MTD) is reached in participants with SCLC, high-grade

{ "short_title": "Abbvie M23-385", "data_mode": "900", "data_mode_number": "000002320", "official_title": " A Phase 1 first-in-human study evaluating safety, pharmacokinetics and efficacy of ABBV-706 as monotherapy and in combination with budigalimab (ABBV-181), carboplatin, or cisplatin in adult subjects with advanced solid tumors.", "accrual_state": "running", "therapeutic_value": "therapeutic", "therapieansatz_value": "palliativ", "therapieintervention_value": "not_applicable", "therapielinie_value": "not_applicable", "ctgov_number": "NCT05599984", "eudract_number": "2023-504598-18", "general_contact_email": "ectu@ukdd.de", "general_contact_phone": "+49 351-4587566", "hauptpruefer_dd_name": "Prof. Dr. med. habil Martin Wermke", "description_laie_de": "Ziel dieser Studie ist es, die Sicherheit, Vertr\u00e4glichkeit, Pharmakokinetik und vorl\u00e4ufige Wirksamkeit von ABBV-706 als Monotherapie und in Kombination mit Budigalimab, Carboplatin oder Cisplatin zu untersuchen. ABBV-706 ist ein Pr\u00fcfpr\u00e4parat, das f\u00fcr die Behandlung von kleinzelligem Lungenkrebs (SCLC), hochgradigen Tumoren des zentralen Nervensystems (ZNS) und hochgradigen neuroendokrinen Karzinomen (NEC) entwickelt wird. In dieser Studie gibt es mehrere Behandlungsarme. Die Teilnehmer erhalten ABBV-706 entweder als Einzelwirkstoff oder in Kombination mit Budigalimab (einem anderen Pr\u00fcfpr\u00e4parat), Carboplatin oder Cisplatin in unterschiedlichen Dosierungen. Ungef\u00e4hr 350 erwachsene Teilnehmer werden an verschiedenen Standorten weltweit in die Studie aufgenommen. In Teil 1 (Dosiseskalation) wird ABBV-706 in ansteigenden Dosen als Monotherapie intraven\u00f6s infundiert, bis die maximal vertr\u00e4gliche Dosis (MTD) bei Teilnehmern mit SCLC, hochgradigem", "description_laie_en": "The objective of this study is to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of ABBV-706 as monotherapy and in combination with budigalimab, carboplatin or cisplatin. ABBV-706 is an investigational drug being developed for the treatment of small cell lung cancer (SCLC), high-grade central nervous system (CNS) tumors and high-grade neuroendocrine carcinoma (NEC). There are multiple treatment arms in this trial. Participants will receive ABBV-706 either as a single agent or in combination with budigalimab (another investigational drug), carboplatin or cisplatin at different doses. Approximately 350 adult participants will be enrolled in the study at various sites worldwide. In Part 1 (dose escalation), ABBV-706 will be infused intravenously in increasing doses as monotherapy until the maximum tolerated dose (MTD) is reached in participants with SCLC, high-grade", "description_expert_de": "Ziel dieser Studie ist es, die Sicherheit, Vertr\u00e4glichkeit, Pharmakokinetik und vorl\u00e4ufige Wirksamkeit von ABBV-706 als Monotherapie und in Kombination mit Budigalimab, Carboplatin oder Cisplatin zu untersuchen. ABBV-706 ist ein Pr\u00fcfpr\u00e4parat, das f\u00fcr die Behandlung von kleinzelligem Lungenkrebs (SCLC), hochgradigen Tumoren des zentralen Nervensystems (ZNS) und hochgradigen neuroendokrinen Karzinomen (NEC) entwickelt wird. In dieser Studie gibt es mehrere Behandlungsarme. Die Teilnehmer erhalten ABBV-706 entweder als Einzelwirkstoff oder in Kombination mit Budigalimab (einem anderen Pr\u00fcfpr\u00e4parat), Carboplatin oder Cisplatin in unterschiedlichen Dosierungen. Ungef\u00e4hr 350 erwachsene Teilnehmer werden an verschiedenen Standorten weltweit in die Studie aufgenommen. In Teil 1 (Dosiseskalation) wird ABBV-706 in ansteigenden Dosen als Monotherapie intraven\u00f6s infundiert, bis die maximal vertr\u00e4gliche Dosis (MTD) bei Teilnehmern mit SCLC, hochgradigem", "description_expert_en": "Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess safety, tolerability, pharmacokinetics and preliminary efficacy of ABBV-706 as a monotherapy and in combination with budigalimab, carboplatin, or cisplatin. ABBV-706 is an investigational drug being developed for the treatment of small cell lung cancer (SCLC), high-grade central nervous system (CNS) tumors and high-grade neuroendocrine carcinomas (NECs). There are multiple treatment arms in this study. Participants will either receive ABBV-706 as a single agent or in combination with budigalimab (another investigational drug), carboplatin or cisplatin at different doses. Approximately 350 adult participants will be enrolled in the study across sites worldwide. In part 1 (dose escalation), ABBV-706 will be intravenously infused in escalating doses as a monotherapy until the maximum tolerated dose (MTD) is determined in participants with SCLC, high-grade", "rechtsgrundlage_value": "AMG", "phase_amg_value": "I", "main_cat_id": 10, "sub_cat_id": 50 }

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