🏛️ Verified NIH Record • Updated 2026-06-15

Dose Escalation Study of a PD1-LAG3 Bispecific Antibody in Patients With Advanced and/or Metastatic Solid Tumors (NCT04140500)

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

🔵 Active, Not Recruiting Phase1 / Phase2 💊 Investigational Drug / Biologic Sponsor: Hoffmann-La Roche

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: Rigshospitalet — København Ø

Age range: 18 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (25 Sites)

  • Rigshospitalet — København Ø,
  • Odense Universitetshospital, Onkologisk Afdeling R — Odense C,
  • LLC Arensia Explorer Medicine — Tbilisi,
  • Hadassah University Hospital - Ein Kerem — Jerusaelm,
  • Rabin MC — Petah Tikva,
  • Chaim Sheba medical center, Oncology division — Ramat Gan,
  • Hospital Civil de Guadalajara Fray Antonio Alcalde — Guadalajara, Jalisco
  • Inst. Nacional de Cancerología — Mexico City, Mexico CITY (federal District)
  • Consultorio Médico Jordi Guzmán Casta — Querétaro City, Querétaro
  • National University Hospital — Singapore,
  • National Cancer Centre — Singapore,
  • Seoul National University Bundang Hospital — Seongnam-si,
  • Severance Hospital, Yonsei University Health System — Seoul,
  • Asan Medical Center — Seoul,
  • Clinica Universitaria de Navarra — Pamplona, Navarre
  • Vall d?Hebron Institute of Oncology (VHIO), Barcelona — Barcelona,
  • Clinica Universidad de Navarra Madrid — Madrid,
  • START Madrid-FJD, Hospital Fundacion Jimenez Diaz — Madrid,
  • START Madrid. Centro Integral Oncologico Clara Campal — Madrid,
  • Adana City Hospital, Medical Oncology — Adana,
  • Ankara City Hospital — Ankara,
  • Hacettepe Uni Medical Faculty Hospital — Sihhiye/Ankara,
  • Ankara Abdurrahman Yurtaslan Oncology Training and Research Hospital Phase 1 Center — Yen?mahalle,
  • Queen Elizabeth Hospital — Birmingham,
  • Christie Hospital NHS Trust — Manchester,

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

Explore by condition: All Solid Tumors clinical trials

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗