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ACTIVE NOT RECRUITING
NCT04140500
PHASE1/PHASE2

Dose Escalation Study of a PD1-LAG3 Bispecific Antibody in Patients With Advanced and/or Metastatic Solid Tumors

Sponsor: Hoffmann-La Roche

View on ClinicalTrials.gov

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

Interventions

DRUG

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