Dose Escalation Study of a PD1-LAG3 Bispecific Antibody in Patients With Advanced and/or Metastatic Solid Tumors
NCT ID: NCT04140500
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
170 participants
INTERVENTIONAL
2019-11-11
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Part A: Single-Agent Dose Escalation
Participants will receive RO7247669 every 2 weeks (Q2W) or every 3 weeks (Q3W) up to the maximum tolerated dose (MTD) until disease progression, unacceptable drug toxicity, or withdrawal of consent, for up to 24 months.
RO7247669
Participants will receive intravenous (IV) RO7247669 at different doses either every 2 weeks (Q2W) or every 3 weeks (Q3W)
Part B: Tumor Specific Expansion Cohorts
Participants with selected solid tumor indications will receive RO7247669 at a dose derived from Part A until disease progression, unacceptable drug toxicity, or withdrawal of consent, for up to 24 months.
RO7247669
Participants will receive intravenous (IV) RO7247669 at different doses either every 2 weeks (Q2W) or every 3 weeks (Q3W)
Interventions
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RO7247669
Participants will receive intravenous (IV) RO7247669 at different doses either every 2 weeks (Q2W) or every 3 weeks (Q3W)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
* 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
* 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
* 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
* 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
* Participants with the following muations, rearrangements, translocations are not eligible: EGFR, ALK, ROS1, BRAFV600E, and NTRK
* Prior therapy with any immunomodulatory agents
* Prior therapy for metastatic disease is not permitted
* Neo-adjuvant anti-PD-1 or anti-PD-L1 therapy is not allowed
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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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
Countries
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Other Identifiers
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2019-000779-18
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
NP41300
Identifier Type: -
Identifier Source: org_study_id