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Active (not recruiting) Phase 1 NCT04250155

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

Phase 1 – testing safety in a small group of people
Conditions: Solid Tumors

Sponsor: Genentech, Inc.

trial.available_in: БГ
Overview
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.
Who can participate
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
Locations 9
Australia (1)
Parkville Cancer Clinical Trial Unit (PCCTU)
Melbourne , Victoria
Belgium (1)
GasthuisZusters Antwerpen
Wilrijk , Antwerp
Brazil (1)
Hospital de Clinicas de Porto Alegre HCPA PPDS
Porto Alegre , Rio Grande do Sul
Canada (1)
Princess Margaret Hospital
Toronto , Ontario
Italy (1)
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan , Lombardy
Netherlands (1)
Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis
Amsterdam , North Holland
South Korea (1)
Seoul National University Bundang Hospital
Seongnam-si
Spain (1)
Clinica Universitaria de Navarra
Pamplona , Navarre
United States (1)
Honor Health Research Institute
Scottsdale , Arizona
Technical details
Status
Active (not recruiting)
Phase
Phase 1
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
09.03.2020
Completion date
15.06.2026
Registry ID
NCT04250155
Source
anzctr
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Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.