- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04140500
Dose Escalation Study of a PD1-LAG3 Bispecific Antibody in Patients With Advanced and/or Metastatic Solid Tumors
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Contact
- Name: Reference Study ID: NP41300 https://forpatients.roche.com/
- Phone Number: 888-662-6728 (U.S. and Canada)
- Email: global-roche-genentech-trials@gene.com
Study Locations
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RS
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Porto Alegre, RS, Brazil, 90035-903
- Recruiting
- Hospital de Clinicas de Porto Alegre X; Centro de Pesquisa Clinica
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SP
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Sao Paulo, SP, Brazil, 01246-000
- Recruiting
- Instituto do Cancer do Estado de Sao Paulo - ICESP
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København Ø, Denmark, 2100
- Recruiting
- Rigshospitalet; Fase 1 Enhed - Onkologi
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Odense C, Denmark, 5000
- Active, not recruiting
- Odense Universitetshospital, Onkologisk Afdeling R
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Tbilisi, Georgia, 0112
- Recruiting
- LLC Arensia Explorer Medicine
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Jerusalem, Israel, 9112001
- Active, not recruiting
- Hadassah University Hospital - Ein Kerem; Oncology
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Petach Tikva, Israel, 4941492
- Recruiting
- Rabin MC; Davidof Center - Oncology Institute
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Ramat Gan, Israel, 5262000
- Completed
- Chaim Sheba medical center, Oncology division
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Seongnam-si, Korea, Republic of, 463-707
- Completed
- Seoul National University Bundang Hospital
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Seoul, Korea, Republic of, 05505
- Completed
- Asan Medical Center
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Seoul, Korea, Republic of, 03080
- Completed
- Seoul National University Hospital
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Seoul, Korea, Republic of, 03722
- Terminated
- Severance Hospital, Yonsei University Health System
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Jalisco
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Guadalajara, Jalisco, Mexico, 44280
- Recruiting
- Hospital Civil de Guadalajara Fray Antonio Alcalde
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Mexico CITY (federal District)
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Mexico City, Mexico CITY (federal District), Mexico, 14080
- Recruiting
- Inst. Nacional de Cancerología; Pneumology
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Queretaro
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Querétaro, Queretaro, Mexico, 76226
- Recruiting
- Consultorio Médico Jordi Guzmán Casta
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Chisinau, Moldova, Republic of, MD-2025
- Recruiting
- The Institute of Oncology, ARENSIA Exploratory Medicine
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Porto, Portugal, 4200-072
- Withdrawn
- IPO do Porto; Servico de Oncologia Medica
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Singapore, Singapore, 119228
- Recruiting
- National University Hospital; National University Cancer Institute, Singapore (NCIS)
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Singapore, Singapore, 168583
- Recruiting
- National Cancer Centre; Medical Oncology
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Barcelona, Spain, 08003
- Recruiting
- Hospital del Mar; Servicio de Oncologia
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Barcelona, Spain, 08035
- Recruiting
- Vall d?Hebron Institute of Oncology (VHIO), Barcelona
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Madrid, Spain, 28027
- Recruiting
- Clinica Universidad de Navarra Madrid; Servicio de Oncología
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Madrid, Spain, 28040
- Recruiting
- START Madrid-FJD, Hospital Fundacion Jimenez Diaz
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Madrid, Spain, 28050
- Recruiting
- START Madrid. Centro Integral Oncologico Clara Campal; CIOCC
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Navarra
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Pamplona, Navarra, Spain, 31008
- Recruiting
- Clinica Universitaria de Navarra; Servicio de Oncologia
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Adana, Turkey, 01060
- Active, not recruiting
- Adana City Hospital, Medical Oncology
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Ankara, Turkey, 06800
- Recruiting
- Ankara City Hospital; Oncology
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Istanbul, Turkey
- Recruiting
- Koc University Hospital; Oncology
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Sihhiye/Ankara, Turkey, 06230
- Recruiting
- Hacettepe Uni Medical Faculty Hospital; Oncology Dept
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Birmingham, United Kingdom, B15 2TH
- Recruiting
- Queen Elizabeth Hospital
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Manchester, United Kingdom, M20 4BX
- Completed
- Christie Hospital NHS Trust; Experimental Cancer Medicine Team
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California
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San Diego, California, United States, 92123
- Withdrawn
- Sharp Memorial Hospital
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Michigan
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Detroit, Michigan, United States, 48202
- Withdrawn
- Henry Ford Hospital; Hematology/Oncology Phase 1
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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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.
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Participants will receive intravenous (IV) RO7247669 at different doses either every 2 weeks (Q2W) or every 3 weeks (Q3W)
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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.
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Participants will receive intravenous (IV) RO7247669 at different doses either every 2 weeks (Q2W) or every 3 weeks (Q3W)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Part A: Percentage of Participants with Dose-Limiting Toxicities (DLTs)
Time Frame: Days 1-21 (Q2W dosing) or Days 1-28 (Q3W dosing) of Cycle 1
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Days 1-21 (Q2W dosing) or Days 1-28 (Q3W dosing) of Cycle 1
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Part A: Percentage of Participants with Adverse Events
Time Frame: Baseline through the end of study (up to 24 months)
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Baseline through the end of study (up to 24 months)
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Part B: Objective Response Rate (ORR)
Time Frame: Up to 24 months
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Up to 24 months
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Part B: Disease Control Rate (DCR), Defined as ORR + Stable Disease Rate (SDR)
Time Frame: Up to 24 months
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Up to 24 months
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Part B: Duration of Response (DOR)
Time Frame: Up to 24 months
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Up to 24 months
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Part B: Progression-free Survival (PFS), Defined as the Time from the First Study Treatment to the First Occurrence of Progression per Investigator Assessment or Death from any Cause, Whichever Occurs First
Time Frame: Up to 24 months
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Up to 24 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Parts A and B: Maximum Concentration (Cmax) of RO7247669
Time Frame: At pre-defined intervals from Day 1 of Cycle 1 through final study visit (up to 24 months)
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At pre-defined intervals from Day 1 of Cycle 1 through final study visit (up to 24 months)
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Parts A and B: Time of Maximum Concentration (Tmax) of RO7247669
Time Frame: At pre-defined intervals from Day 1 of Cycle 1 through final study visit (up to 24 months)
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At pre-defined intervals from Day 1 of Cycle 1 through final study visit (up to 24 months)
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Parts A and B: Clearance (CL) of RO7247669
Time Frame: At pre-defined intervals from Day 1 of Cycle 1 through final study visit (up to 24 months)
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At pre-defined intervals from Day 1 of Cycle 1 through final study visit (up to 24 months)
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Parts A and B: Volume of Distribution at Steady State (Vss) of RO7247669
Time Frame: At pre-defined intervals from Day 1 of Cycle 1 through final study visit (up to 24 months)
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At pre-defined intervals from Day 1 of Cycle 1 through final study visit (up to 24 months)
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Parts A and B: Area Under the Curve (AUC) of RO7247669
Time Frame: At pre-defined intervals from Day 1 of Cycle 1 through final study visit (up to 24 months)
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At pre-defined intervals from Day 1 of Cycle 1 through final study visit (up to 24 months)
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Parts A and B: Half-Life (T1/2) of RO7247669
Time Frame: At pre-defined intervals from Day 1 of Cycle 1 through final study visit (up to 24 months)
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At pre-defined intervals from Day 1 of Cycle 1 through final study visit (up to 24 months)
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Parts A and B: Percentage of Participants with Anti-Drug Antibodies (ADA) to RO7247669
Time Frame: Day 1 of each Cycle, starting with Cycle 1, through final study visit (up to 24 months)
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Day 1 of each Cycle, starting with Cycle 1, through final study visit (up to 24 months)
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Part B: Change from Baseline in T-Cell Activity
Time Frame: At pre-defined intervals from Day 1 of Cycle 1 through final study visit (up to 24 months)
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At pre-defined intervals from Day 1 of Cycle 1 through final study visit (up to 24 months)
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Part A: Percentage of Receptors Occupied by RO7247669
Time Frame: At pre-defined intervals from Day 1 of Cycle 1 through final study visit (up to 24 months)
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At pre-defined intervals from Day 1 of Cycle 1 through final study visit (up to 24 months)
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Part A: ORR
Time Frame: At pre-defined intervals from initial dose up to 24 months
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At pre-defined intervals from initial dose up to 24 months
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Part A: DCR
Time Frame: At pre-defined intervals from initial dose up to 24 months
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At pre-defined intervals from initial dose up to 24 months
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Part A: PFS
Time Frame: At pre-defined intervals from initial dose up to 24 months
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At pre-defined intervals from initial dose up to 24 months
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Part A: DOR
Time Frame: At pre-defined intervals from initial dose up to 24 months
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At pre-defined intervals from initial dose up to 24 months
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Part B: Percentage of Participants with Adverse Events
Time Frame: Baseline through the end of study (up to 24 months)
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Baseline through the end of study (up to 24 months)
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Clinical Trials, Hoffmann-La Roche
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Head and Neck Neoplasms
- Esophageal Diseases
- Neoplasms, Squamous Cell
- Carcinoma, Squamous Cell
- Esophageal Neoplasms
- Esophageal Squamous Cell Carcinoma
Other Study ID Numbers
- NP41300
- 2019-000779-18 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on RO7247669
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Hoffmann-La RocheRecruitingMelanomaBrazil, Czechia, Spain, Turkey, New Zealand, Canada, Australia, Poland, Slovakia, Greece
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Hoffmann-La RocheTempest Therapeutics; Adagene IncRecruitingAdvanced Liver CancersKorea, Republic of, Taiwan, United States, Israel, China, France, New Zealand
-
Hoffmann-La RocheRecruitingMelanomaUnited States, France, Australia, Spain, Netherlands, Italy
-
Hoffmann-La RocheRecruitingUrothelial CancerKorea, Republic of, United States, Brazil, China, France, Germany, Mexico, Poland, Denmark, Turkey, Australia, Greece, Spain, United Kingdom, Italy
-
Hoffmann-La RocheRecruitingRenal Cell CarcinomaKorea, Republic of, United States, China, Germany, France, Spain, United Kingdom, Poland, Australia
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Hoffmann-La RocheActive, not recruitingAdvanced or Metastatic Esophageal Squamous Cell CarcinomaKorea, Republic of, Argentina, Denmark, France, Spain, Brazil, United Kingdom, Turkey, Czechia, Thailand, Russian Federation, Italy, Poland, Taiwan, Singapore, Ukraine, Kenya, Hungary
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Hoffmann-La RocheRecruitingBreast CancerKorea, Republic of, United States, Israel, Argentina, Mexico, Brazil, Peru, Spain, Taiwan, South Africa, Czechia, Australia, Germany
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Hoffmann-La RocheRecruitingCarcinoma, HepatocellularKorea, Republic of, Taiwan, United States, France, Spain, New Zealand, United Kingdom
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Hoffmann-La RocheRecruitingNon-small Cell Lung CancerKorea, Republic of, United States, Brazil, Spain, France, Germany, Belgium, Canada, Turkey, Italy, Australia, Mexico