An Open-Label Dose-Escalation Study to Evaluate XmAb24306 as a Single Agent and in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Solid Tumors
Фаза 1 – тестване на безопасността при малка група хора
Заболявания:
Solid Tumors
Спонсор: Genentech, Inc.
Налично на:
БГ
Обобщение
This study will evaluate the safety, tolerability, pharmacokinetics, and activity of XmAb24306 alone or in combination with a checkpoint inhibitor treatment in participants with locally advanced or metastatic solid tumors.
Кой може да участва
Key General Inclusion Criteria
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
* Life expectancy \>/= 12 weeks
* Adequate hematologic and end-organ function
* For participants receiving therapeutic anticoagulation: stable anticoagulant regimen
* Negative serum pregnancy test for women of childbearing potential
* Histologically confirmed locally advanced, recurrent, or metastatic incurable solid tumor malignancy
* Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
* Availability of representative tumor specimens
Key General Exclusion Criteria
* Pregnant or breastfeeding, or intending to become pregnant during the study
* Significant cardiovascular disease
* Current treatment with medications that prolong the QT interval
* Known clinically significant liver disease
* Poorly controlled Type 2 diabetes mellitus
* Symptomatic, untreated, or actively progressing CNS metastases
* History of leptomeningeal disease
* History of malignancy other than disease under study within 3 years prior to screening
* Active or history of autoimmune disease or immune deficiency
* Active tuberculosis, hepatitis B, hepatitis C, or known/suspected Epstein Barr virus infection
* Positive for HIV infection
* Prior allogeneic stem cell or solid organ transplantation
Места на провеждане
9
Австралия (1)
Parkville Cancer Clinical Trial Unit (PCCTU)
Melbourne , Victoria
Белгия (1)
GasthuisZusters Antwerpen
Wilrijk , Antwerp
Бразилия (1)
Hospital de Clinicas de Porto Alegre HCPA PPDS
Porto Alegre , Rio Grande do Sul
Канада (1)
Princess Margaret Hospital
Toronto , Ontario
Италия (1)
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan , Lombardy
Нидерландия (1)
Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis