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Dose Escalation Study of a PD1-LAG3 Bispecific Antibody in Patients With Advanced and/or Metastatic Solid Tumors
Dose Escalation Study of a PD1-LAG3 Bispecific Antibody in Patients With Advanced and/or Metastatic Solid Tumors
Active Not RecruitingPhase 1, Phase 2
Sponsor: Hoffmann-La Roche
Conditions: Solid Tumors, Metastatic Melanoma, Non-small Cell Lung Cancer, Esophageal Squamous Cell Carcinoma
Interventions: RO7247669
Countries: Denmark, Georgia, Israel, Mexico, Singapore, South Korea, Spain, Turkey (Türkiye)
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.
Eligibility overview
Sex: ALL
Age: 18 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
Eligibility 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
Locations (25)
- København Ø, Denmark
- Odense C, Denmark
- Tbilisi, Georgia
- Jerusaelm, Israel
- Petah Tikva, Israel
- Ramat Gan, Israel
- Guadalajara, Jalisco, Mexico
- Mexico City, Mexico CITY (federal District), Mexico
- Querétaro City, Querétaro, Mexico
- Singapore, Singapore
- Singapore, Singapore
- Seongnam-si, South Korea
- Seoul, South Korea
- Seoul, South Korea
- Pamplona, Navarre, Spain
- Barcelona, Spain
- Madrid, Spain
- Madrid, Spain
- Madrid, Spain
- Adana, Turkey (Türkiye)
- Ankara, Turkey (Türkiye)
- Sihhiye/Ankara, Turkey (Türkiye)
- Yen?mahalle, Turkey (Türkiye)
- Birmingham, United Kingdom
- Manchester, United Kingdom