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Dose Escalation Study of a PD1-LAG3 Bispecific Antibody in Patients With Advanced and/or Metastatic Solid Tumors
Sponsor: Hoffmann-La Roche
Summary
This is a first-in-human, open-label, multicenter, Phase I multiple-ascending dose (MAD) study of RO7247669, an anti PD-1 (programmed death-1) and LAG-3 (Lymphocyte-activation gene 3) bispecific antibody, for participants with advanced and/or metastatic solid tumors. This study aims to establish the maximum tolerated dose (MTD) and/or define the recommended phase 2 dose (RP2D) based on the safety, tolerability, pharmacokinetic (PK) and/or pharmacodynamic (PD) profile of RO7247669, and to evaluate preliminary anti-tumor activity in participants with solid tumors. An expansion part of the study is planned to enroll tumor-specific cohorts to evaluate anti-tumor activity of the MTD and/or RP2D of RO7247669 and to confirm safety and tolerability in participants with selected tumor types.
Official title: An Open Label, Multicenter, Dose Escalation, Phase 1 Study to Evaluate Safety/Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Anti Tumor Activity of RO7247669, a PD1-LAG3 Bispecific Antibody, in Patients With Advanced and/or Metastatic Solid Tumors
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
170
Start Date
2019-11-11
Completion Date
2027-06-30
Last Updated
2026-03-18
Healthy Volunteers
No
Conditions
Interventions
RO7247669
Participants will receive intravenous (IV) RO7247669 at different doses either every 2 weeks (Q2W) or every 3 weeks (Q3W)
Locations (25)
Rigshospitalet
København Ø, Denmark
Odense Universitetshospital, Onkologisk Afdeling R
Odense C, Denmark
LLC Arensia Explorer Medicine
Tbilisi, Georgia
Hadassah University Hospital - Ein Kerem
Jerusaelm, Israel
Rabin MC
Petah Tikva, Israel
Chaim Sheba medical center, Oncology division
Ramat Gan, Israel
Hospital Civil de Guadalajara Fray Antonio Alcalde
Guadalajara, Jalisco, Mexico
Inst. Nacional de Cancerología
Mexico City, Mexico CITY (federal District), Mexico
Consultorio Médico Jordi Guzmán Casta
Querétaro City, Querétaro, Mexico
National University Hospital
Singapore, Singapore
National Cancer Centre
Singapore, Singapore
Seoul National University Bundang Hospital
Seongnam-si, South Korea
Severance Hospital, Yonsei University Health System
Seoul, South Korea
Asan Medical Center
Seoul, South Korea
Clinica Universitaria de Navarra
Pamplona, Navarre, Spain
Vall d?Hebron Institute of Oncology (VHIO), Barcelona
Barcelona, Spain
Clinica Universidad de Navarra Madrid
Madrid, Spain
START Madrid-FJD, Hospital Fundacion Jimenez Diaz
Madrid, Spain
START Madrid. Centro Integral Oncologico Clara Campal
Madrid, Spain
Adana City Hospital, Medical Oncology
Adana, Turkey (Türkiye)
Ankara City Hospital
Ankara, Turkey (Türkiye)
Hacettepe Uni Medical Faculty Hospital
Sihhiye/Ankara, Turkey (Türkiye)
Ankara Abdurrahman Yurtaslan Oncology Training and Research Hospital Phase 1 Center
Yen?mahalle, Turkey (Türkiye)
Queen Elizabeth Hospital
Birmingham, United Kingdom
Christie Hospital NHS Trust
Manchester, United Kingdom