Last updated 3 months ago
Dose Escalation Study of a PD1-LAG3 Bispecific Antibody in Patients With Advanced and/or Metastatic Solid Tumors
320 patients around the world
Available in Spain, United States, Brazil
Hoffmann-La Roche
8Research sites
320Patients around the world
This study is for people with
Solid tumors
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- Patient must have histologically or cytologically confirmed advanced and/or metastatic solid tumor malignancies for which standard curative or palliative measures do not exist, are no longer effective, or are not acceptable to the patientEastern Cooperative Oncology Group Performance Status 0-1Fresh biopsies may be requiredWomen of childbearing potential and male participants must agree to remain abstinent or use contraceptive methods as defined by the protocolAdditional Specific Inclusion Criteria for Participants with MelanomaAdditional Specific Inclusion Criteria for Participants with Non-Small Cell Lung Cancer who Previously Received Treatment for Metastatic DiseaseAdditional Specific Inclusion Criteria for Participants with Esophageal Squamous Cell CarcinomaAdditional Specific Inclusion Criteria for Participants with Non-Small Cell Lung Cancer who Previously did not Receive Treatment for Metastatic Disease
- Pregnancy, lactation, or breastfeedingKnown hypersensitivity to any of the components of RO7247669Active or untreated central nervous system (CNS) metastasesAn active second malignancyEvidence of concomitant diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the participant at high risk from treatment complicationsPositive HIV, hepatitis B, or hepatitis C test resultKnown active or uncontrolled bacterial, viral, fungal, mycobacterial, parasitic, or other infectionVaccination with live vaccines within 28 days prior to Cycle 1 Day 1Treatment with oral or IV antibiotics within 2 weeks prior to Cycle 1 Day 1Active or history of autoimmune disease or immune deficiencyPrior treatment with adoptive cell therapies, such as CAR-T therapiesConcurrent therapy with any other investigational drug < 28 days or 5 half-lives of the drug, whichever is shorter, prior to the first RO7247669 administrationRegular immunosuppressive therapyRadiotherapy within the last 4 weeks before start of study drug treatment, with the exception of limited palliative radiotherapyPrior treatment with a lymphocyte activation gene-3 (LAG-3) inhibitorAdditional Specific Exclusion Criteria for Participants with Non-Small Cell Lung Cancer who Previously Received Treatment for Metastatic DiseaseAdditional Specific Exclusion Criteria for Participants with Esophageal Squamous Cell CarcinomaAdditional Specific Exclusion Criteria for Participants with Non-Small Cell Lung Cancer who Previously did not Receive Treatment for Metastatic Disease
Sites
Hospital de Clínicas de Porto Alegre
Recruiting
Instituto do Câncer do Estado de São Paulo "Octavio Frias de Oliveira" - ICESP
Recruiting
Clínica Universidad de Navarra - Sede Pamplona
Recruiting
Hospital del Mar
Recruiting
Hospital Vall de Hebrón
Recruiting
Clínica Universitaria de Navarra - Sede Madrid
Recruiting
Hospital Universitario Fundacion Jimenez Diaz
Recruiting
Centro Oncológico Clara Campal - CIOCC
Recruiting
SponsorHoffmann-La Roche
Conditions
Solid tumors
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT04140500
