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

  • Non-Small Cell Lung Cancer
  • Solid Tumors
Trial Status:

Recruiting

This trial runs in
Countries
  • Denmark
  • Israel
  • Singapore
  • South Korea
  • Spain
  • United Kingdom
  • United States
Trial Identifier:

NCT04140500 2019-000779-18 NP41300

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      The source of the below information is the publicly available website ClinicalTrials.gov. It has been summarised and edited into simpler language.

      The below information is taken directly from the publicly available website ClinicalTrials.gov within a week of any updates, and has not been edited.

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      Trial Summary

      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.

      Hoffmann-La Roche Sponsor
      Phase 1 Phase
      NCT04140500 , NP41300 , 2019-000779-18 Trial Identifier
      RO7247669 Treatments
      Solid Tumors, Metastatic Melanoma, Non-small Cell Lung Cancer, Esophageal Squamous Cell Carcinoma Condition
      Official Title

      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

      Eligibility Criteria

      All Gender
      ≥18 Years Age
      No Healthy Volunteers
      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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