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Clinical Trial Finder

Search Results

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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04140500
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1/Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Hoffmann-La Roche
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Clinical Trials
Principal Investigator Affiliation Hoffmann-La Roche
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Active, not recruiting
Countries Denmark, Georgia, Israel, Mexico, Singapore, South Korea, Spain, Turkey (Türkiye), United Kingdom
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Solid Tumors, Metastatic Melanoma, Non-small Cell Lung Cancer, Esophageal Squamous Cell Carcinoma
Arms & Interventions

Arms

Experimental: 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.

Experimental: 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.

Interventions

Drug: - RO7247669

Participants will receive intravenous (IV) RO7247669 at different doses either every 2 weeks (Q2W) or every 3 weeks (Q3W)

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Rigshospitalet, København Ø 11746747, Denmark

Status

Address

Rigshospitalet

København Ø 11746747, , 2100

Odense C 11746507, Denmark

Status

Address

Odense Universitetshospital, Onkologisk Afdeling R

Odense C 11746507, , 5000

LLC Arensia Explorer Medicine, Tbilisi 611717, Georgia

Status

Address

LLC Arensia Explorer Medicine

Tbilisi 611717, , 0112

Hadassah University Hospital - Ein Kerem, Jerusaelm, Israel

Status

Address

Hadassah University Hospital - Ein Kerem

Jerusaelm, , 9112001

Rabin MC, Petah Tikva 293918, Israel

Status

Address

Rabin MC

Petah Tikva 293918, , 4941492

Ramat Gan 293788, Israel

Status

Address

Chaim Sheba medical center, Oncology division

Ramat Gan 293788, , 5262000

Guadalajara 4005539, Jalisco 4004156, Mexico

Status

Address

Hospital Civil de Guadalajara Fray Antonio Alcalde

Guadalajara 4005539, Jalisco 4004156, 44280

Inst. Nacional de Cancerología, Mexico City 3530597, Mexico CITY (federal District), Mexico

Status

Address

Inst. Nacional de Cancerología

Mexico City 3530597, Mexico CITY (federal District), 14080

Consultorio Médico Jordi Guzmán Casta, Querétaro City 3991164, Querétaro 3520914, Mexico

Status

Address

Consultorio Médico Jordi Guzmán Casta

Querétaro City 3991164, Querétaro 3520914, 76226

National University Hospital, Singapore 1880252, Singapore

Status

Address

National University Hospital

Singapore 1880252, , 119228

National Cancer Centre, Singapore 1880252, Singapore

Status

Address

National Cancer Centre

Singapore 1880252, , 169610

Seongnam-si 1897000, South Korea

Status

Address

Seoul National University Bundang Hospital

Seongnam-si 1897000, , 13605

Seoul 1835848, South Korea

Status

Address

Severance Hospital, Yonsei University Health System

Seoul 1835848, , 03722

Asan Medical Center, Seoul 1835848, South Korea

Status

Address

Asan Medical Center

Seoul 1835848, , 05505

Clinica Universitaria de Navarra, Pamplona 3114472, Navarre 3115609, Spain

Status

Address

Clinica Universitaria de Navarra

Pamplona 3114472, Navarre 3115609, 31008

Barcelona 3128760, Spain

Status

Address

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

Barcelona 3128760, , 08035

Clinica Universidad de Navarra Madrid, Madrid 3117735, Spain

Status

Address

Clinica Universidad de Navarra Madrid

Madrid 3117735, , 28027

Madrid 3117735, Spain

Status

Address

START Madrid-FJD, Hospital Fundacion Jimenez Diaz

Madrid 3117735, , 28040

Madrid 3117735, Spain

Status

Address

START Madrid. Centro Integral Oncologico Clara Campal

Madrid 3117735, , 28050

Adana City Hospital, Medical Oncology, Adana 325363, Turkey (Türkiye)

Status

Address

Adana City Hospital, Medical Oncology

Adana 325363, , 01060

Ankara City Hospital, Ankara 323786, Turkey (Türkiye)

Status

Address

Ankara City Hospital

Ankara 323786, , 06800

Hacettepe Uni Medical Faculty Hospital, Sihhiye/Ankara, Turkey (Türkiye)

Status

Address

Hacettepe Uni Medical Faculty Hospital

Sihhiye/Ankara, , 06230

Yen?mahalle, Turkey (Türkiye)

Status

Address

Ankara Abdurrahman Yurtaslan Oncology Training and Research Hospital Phase 1 Center

Yen?mahalle, , 06200

Queen Elizabeth Hospital, Birmingham 2655603, United Kingdom

Status

Address

Queen Elizabeth Hospital

Birmingham 2655603, , B15 2TH

Christie Hospital NHS Trust, Manchester 2643123, United Kingdom

Status

Address

Christie Hospital NHS Trust

Manchester 2643123, , M20 4BX

Resources

  • Patient and Caregiver Survey
  • Clinical Trial Endpoints
  • Research Resources
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The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.

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