A Dose Escalation and Expansion Study of RO7121661, a PD-1/TIM-3 Bispecific Antibody, in Participants With Advanced and/or Metastatic Solid Tumors

  • Solid Tumors
  • Cancer
Trial Status:

Active, not recruiting

This trial runs in
Countries
  • Denmark
  • France
  • New Zealand
  • South Korea
  • Spain
  • United States
Trial Identifier:

NCT03708328 2018-000982-35 NP40435

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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 single agent RO7121661, an anti PD-1 (programmed death-1) and TIM-3 (T-cell immunoglobulin and mucin domain 3) bispecific antibody, for participants with advanced and/or metastatic solid tumors. The study consists of 2 parts: Dose Escalation (Part A) and Expansion (Parts B1, B2, B3, B4, and B5). The Dose Escalation part will be conducted first to determine the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE) based on safety, tolerability, pharmacokinetic, and/or the pharmacodynamic profile of escalating doses of RO7121661. The Expansion part will enroll tumor-specific cohorts to evaluate anti-tumor activity of the MTD and/or RDE of RO7121661 from Part A (Q2W) and to confirm safety and tolerability in participants with selected tumor types.

      Hoffmann-La Roche Sponsor
      Phase 1 Phase
      NCT03708328 , NP40435 , 2018-000982-35 Trial Identifier
      RO7121661 Treatments
      Solid Tumors, Metastatic Melanoma, Non-small Cell Lung Cancer (NSCLC), Small Cell Lung Cancer (SCLC) Condition
      Official Title

      An Open Label, Multicenter, Dose Escalation and Expansion, Phase 1 Study to Evaluate Safety, Pharmacokinetics, and Preliminary Anti-Tumor Activity of RO7121661, a PD-1/TIM-3 Bispecific Antibody, in Patients With Advanced and/or Metastatic Solid Tumors

      Eligibility Criteria

      All Gender
      ≥ 18 Years Age
      No Healthy Volunteers
      Inclusion Criteria

      General Inclusion Criteria:

      • Part A: 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
      • Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
      • Fresh biopsies may be required
      • Negative HIV, hepatitis B, or hepatitis C test result
      • 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
      • Previously treated with approved anti-programmed death-ligand 1 (PD-L1)/anti-programmed death-1 (PD-1) agents with or without approved anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) therapy and up to one additional treatment regimen

      Additional Specific Inclusion Criteria for Participants with Non-small Cell Lung Cancer (NSCLC) who Previously Received Treatment for Metastatic Disease:

      • Histologically confirmed advanced NSCLC
      • Previously treated with approved PD-L1/PD-1 inhibitors and platinum-based chemotherapy
      • Not more than 2 prior lines of treatment for metastatic disease are allowed prior to enrolling to the study
      • Participants must have experienced initial clinical benefit (stable disease or better) from most recent checkpoint inhibitor (CPI) therapy
      • 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 Non-small Cell Lung Cancer (NSCLC) who Previously Did Not Receive Treatment for Metastatic Disease:

      • Histologically confirmed advanced NSCLC
      • 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 Small Cell Lung Cancer (SCLC):

      • Histologically confirmed SCLC
      • Participants may have had prior chemotherapy, radiation therapy, or declined approved therapies for SCLC

      Additional Specific Inclusion Criteria for Participants with Esophageal Squamous Cell Carcinoma (ESCC):

      • Participants whose major lesion was histologically confirmed as squamous cell carcinoma or adenosquamous cell carcinoma of the esophagus
      • Patients who have previously received not more than 1 prior line of treatment for metastatic disease prior to enrolling to the study
      Exclusion Criteria

      General Exclusion Criteria:

      • Pregnancy, lactation, or breastfeeding
      • Known hypersensitivity to any of the components of RO7121661
      • Active or untreated central nervous system (CNS) metastases
      • An active second malignancy
      • Evidence of concomitant diseases, metabolic dysfunction, physical examination findings, or clinical laboratory findings 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
      • Known active or uncontrolled bacterial, viral, fungal, mycobacterial, parasitic, or other infection
      • 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 T-cell immunoglobulin and mucin domain-3 (TIM-3) inhibitor

      Additional Specific Exclusion Criteria for Participants with NSCLC who Previously Received Treatment for Metastatic Disease:

      - Patients with the following mutations, rearrangements, translocations are not eligible: epidermal growth factor receptor (EGFR); anaplastic lymphoma kinase (ALK); ROS proto-oncogene 1 (ROS1), BRAFV600E, and neurotrophic receptor tyrosine kinase (NTRK)

      Additional Specific Exclusion Criteria for Participants with NSCLC who Did Not Previously Receive Treatment for Metastatic Disease:

      • Prior therapy for metastatic disease
      • Adjuvant anti-PD-1 or anti-PD-L1 therapy

      Additional Specific Exclusion Criteria for Participants with Small-Cell Lung Cancer (SCLC):

      - Prior therapy with any immune CPIs (such as anti-PD-L1/PD-1, CTLA-4)

      Additional Specific Exclusion Criteria for Participants with Esophageal Squamous Cell Carcinoma (ESCC):

      - Prior therapy with any immunomodulatory agents

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