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New Dual-Action antibody takes on Hard-to-Treat cancers

NCT ID NCT04140500

Disease control Sponsor: Hoffmann-La Roche Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 11, 2026 · Updated 1 time

Summary

This early-phase study tests a new drug, RO7247669, that targets two immune system checkpoints (PD-1 and LAG-3) to help the body fight cancer. About 170 adults with advanced solid tumors (including melanoma, lung cancer, and esophageal cancer) who have run out of standard options will receive the drug. The main goals are to find the safest dose and see if the drug can shrink tumors.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

170 people

The number who actually took part.

Started

Nov 2019

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria * 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 patient * Eastern Cooperative Oncology Group Performance Status 0-1 * Fresh biopsies may be required * Women of childbearing potential and male participants must agree to remain abstinent or use contraceptive methods as defined by the protocol Additional Specific Inclusion Criteria for Participants with Melanoma * Histologically confirmed, unresectable stage III or stage IV melanoma * Not more than 2 prior lines of treatment for metastatic disease are allowed prior to enrolling in the study * Prior treatment with an approved anti-PD-1 or anti-PD-L1 agent Additional Specific Inclusion Criteria for Participants with Non-Small Cell Lung Cancer who Previously Received Treatment for Metastatic Disease * Participants with histologically confirmed advanced non-small cell lung cancer * Not more than 2 prior lines of treatment for metastatic disease are allowed prior to enrolling in the study * Previously treated with approved PD-L1/PD-1 inhibitors * Tumor PD-L1 expression as determined by immunohistochemistry assay of archival tumor tissue or tissue obtained at screening Additional Specific Inclusion Criteria for Participants with Esophageal Squamous Cell Carcinoma * Participants whose major lesion was histologically confirmed as squamous cell carcinoma or adenosquamous cell carcinoma of the esophagus * Participants who have previously received not more than 1 prior line of treatment for metastatic disease prior to enrolling in the study Additional Specific Inclusion Criteria for Participants with Non-Small Cell Lung Cancer who Previously did not Receive Treatment for Metastatic Disease * Participants with histologically confirmed advanced non-small cell lung cancer * Tumor PD-L1 expression as determined by immunohistochemistry assay of archival tumor tissue or tissue obtained at screening Exclusion criteria * Pregnancy, lactation, or breastfeeding * Known hypersensitivity to any of the components of RO7247669 * Active or untreated central nervous system (CNS) metastases * An active second malignancy * Evidence 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 complications * Positive HIV, hepatitis B, or hepatitis C test result * Known active or uncontrolled bacterial, viral, fungal, mycobacterial, parasitic, or other infection * Vaccination with live vaccines within 28 days prior to Cycle 1 Day 1 * Treatment with oral or IV antibiotics within 2 weeks prior to Cycle 1 Day 1 * Active or history of autoimmune disease or immune deficiency * Prior treatment with adoptive cell therapies, such as CAR-T therapies * Concurrent therapy with any other investigational drug \< 28 days or 5 half-lives of the drug, whichever is shorter, prior to the first RO7247669 administration * Regular immunosuppressive therapy * Radiotherapy within the last 4 weeks before start of study drug treatment, with the exception of limited palliative radiotherapy * Prior treatment with a lymphocyte activation gene-3 (LAG-3) inhibitor Additional Specific Exclusion Criteria for Participants with Non-Small Cell Lung Cancer who Previously Received Treatment for Metastatic Disease * Participants with the following muations, rearrangements, translocations are not eligible: EGFR, ALK, ROS1, BRAFV600E, and NTRK Additional Specific Exclusion Criteria for Participants with Esophageal Squamous Cell Carcinoma * Prior therapy with any immunomodulatory agents Additional Specific Exclusion Criteria for Participants with Non-Small Cell Lung Cancer who Previously did not Receive Treatment for Metastatic Disease * Prior therapy for metastatic disease is not permitted * Neo-adjuvant anti-PD-1 or anti-PD-L1 therapy is not allowed

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Conditions

The condition(s) this trial relates to.

esophageal squamous cell carcinoma melanoma metastatic melanoma neoplasm non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Esophageal squamous cell carcinoma Metastatic melanoma Non-small cell lung cancer Solid tumors

Contacts and locations

Locations

  • Adana City Hospital, Medical Oncology

    Adana, 01060, Turkey (Türkiye)

  • Ankara Abdurrahman Yurtaslan Oncology Training and Research Hospital Phase 1 Center

    Yen?mahalle, 06200, Turkey (Türkiye)

  • Ankara City Hospital

    Ankara, 06800, Turkey (Türkiye)

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Chaim Sheba medical center, Oncology division

    Ramat Gan, 5262000, Israel

  • Christie Hospital NHS Trust

    Manchester, M20 4BX, United Kingdom

  • Clinica Universidad de Navarra Madrid

    Madrid, 28027, Spain

  • Clinica Universitaria de Navarra

    Pamplona, Navarre, 31008, Spain

  • Consultorio Médico Jordi Guzmán Casta

    Querétaro City, Querétaro, 76226, Mexico

  • Hacettepe Uni Medical Faculty Hospital

    Sihhiye/Ankara, 06230, Turkey (Türkiye)

  • Hadassah University Hospital - Ein Kerem

    Jerusaelm, 9112001, Israel

  • Hospital Civil de Guadalajara Fray Antonio Alcalde

    Guadalajara, Jalisco, 44280, Mexico

  • Inst. Nacional de Cancerología

    Mexico City, Mexico CITY (federal District), 14080, Mexico

  • LLC Arensia Explorer Medicine

    Tbilisi, 0112, Georgia

  • National Cancer Centre

    Singapore, 169610, Singapore

  • National University Hospital

    Singapore, 119228, Singapore

  • Odense Universitetshospital, Onkologisk Afdeling R

    Odense C, 5000, Denmark

  • Queen Elizabeth Hospital

    Birmingham, B15 2TH, United Kingdom

  • Rabin MC

    Petah Tikva, 4941492, Israel

  • Rigshospitalet

    København Ø, 2100, Denmark

  • START Madrid-FJD, Hospital Fundacion Jimenez Diaz

    Madrid, 28040, Spain

  • START Madrid. Centro Integral Oncologico Clara Campal

    Madrid, 28050, Spain

  • Seoul National University Bundang Hospital

    Seongnam-si, 13605, South Korea

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722, South Korea

  • Vall d?Hebron Institute of Oncology (VHIO), Barcelona

    Barcelona, 08035, Spain

More trials for these conditions

Other studies related to the condition(s) this trial covers.