An Open Label, Multicenter, Dose Escalation, Phase I 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 Identifier:
NP41300
CT.gov Identifier:
NCT04140500
EudraCT Identifier:
2019-000779-18
EU Trial (CTIS) Number:
2023-503425-18-00
Study Contact Information:
(210) 593-5651 or [email protected]
Recruitment Complete

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Study Summary

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.

Expansion part: 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.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Solid Tumor
  • Melanoma
  • Non-Small Cell Lung Cancer
  • Esophageal
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I/II
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: Arm
    • Read More
  • Drug: Experimental: Part B: Tumor Specific Expansion Cohorts
  • Drug: Intervention/treatment
  • Drug: ESMO 2022:
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruitment Complete

    Requirements information
    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 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 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
    • Adjuvant anti-PD-1 or anti-PD-L1 therapy is not allowed

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Madrid, Spain (CIOCC)
    Madrid, Spain, 28050
    Investigator
    Emiliano Calvo
    Status
    Recruitment Complete
    Condition(s) Treated at Site
    Solid Tumor
    Melanoma
    Non-Small Cell Lung Cancer
    Esophageal
    Location
    START Madrid, Spain (FJD)
    Madrid, Spain, 28040
    Investigator
    Victor Moreno Garcia
    Status
    Recruitment Complete
    Condition(s) Treated at Site
    Solid Tumor
    Melanoma
    Non-Small Cell Lung Cancer
    Esophageal