A Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7502175 as a Single Agent and in Combination With Checkpoint Inhibitor in Participants With Locally Advanced or Metastatic Solid Tumors

  • Cancer
  • Head and Neck Cancer
  • Squamous Cell Carcinoma
  • Solid Tumors
  • Advanced Solid Tumors
  • Lung Cancer
  • Non-Small Cell Lung Cancer (NSCLC)
  • Breast Cancer
  • Triple Negative Breast Cancer
  • Colorectal Cancer (CRC)
  • Gastric Cancer
  • Non Small Cell Lung Carcinoma
  • Bladder Cancer
  • Urothelial Carcinoma
  • Squamous Cell Carcinoma of the Head and Neck (SCCHN)
  • Esophageal Cancer
  • Hepatocellular Carcinoma (HCC)
  • Metastatic Solid Tumors
  • Skin Cancer
  • Malignant Melanoma
  • Renal Cell Cancer (RCC)
  • Clear Cell Renal Cell Carcinoma
  • Melanoma
  • Cervical Cancer
Please note that the recruitment status of the trial at your site may differ from the overall study status because some study sites may recruit earlier than others.
Trial Status:

Recruiting

This trial runs in
Countries
  • Australia
  • Belgium
  • Canada
  • Netherlands
  • South Korea
  • Spain
  • United States
Trial Identifier:

NCT05581004 2021-006708-34 GO43860

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      The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical trial see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

      The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

      Results Disclaimer

      Trial Summary

      This is a first-in-human study to evaluate the safety, tolerability, pharmacokinetics (PK), and anti-tumor activity of RO7502175 when administered as a single agent and in combination with atezolizumab or pembrolizumab in adult participants with locally advanced or metastatic solid tumors, including non-small-cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), melanoma, triple-negative breast cancer (TNBC), esophageal cancer, gastric cancer, cervical cancer, colorectal cancer (CRC), urothelial carcinoma (UC), clear cell renal cell carcinoma (RCC) and hepatocellular carcinoma (HCC). Participants will be enrolled in 2 stages: dose escalation and dose expansion.

      Genentech, Inc. Sponsor
      Phase 1 Phase
      NCT05581004, GO43860, 2021-006708-34 Trial Identifier
      RO7502175, Atezolizumab Treatments
      Locally Advanced or Metastatic Solid Tumors, NSCLC, HNSCC, Melanoma, TNBC, Esophageal Cancer, Gastric Cancer, Cervical Cancer, Colorectal Cancer, Urothelial Carcinoma, Clear Cell RCC, HCC Condition
      Official Title

      A Phase Ia/Ib, Open Label, Multicenter, Dose-escalation Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7502175 as a Single Agent and in Combination With Checkpoint Inhibitor in Patients With Locally Advanced or Metastatic Solid Tumors

      Eligibility Criteria

      All Gender
      ≥18 Years Age
      No Healthy Volunteers
      Inclusion Criteria
      • Life expectancy at least 12 weeks
      • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
      • Measurable disease according to Response Evaluation criteria in Solid Tumors (RECIST) Version 1.1
      • Histologically confirmed locally advanced, recurrent, or metastatic incurable solid tumor malignancy
      • Tumor Specimen availability
      Exclusion Criteria
      • Pregnant or breastfeeding or intention of becoming pregnant during the study or within 4 months after the final dose of RO7501275, or 4 months after the final dose of pembrolizumab, or 5 months after the final dose of atezolizumab
      • Any anti-cancer therapy, whether investigational or approved, including chemotherapy, hormonal therapy, or radiotherapy, within 3 weeks prior to initiation of study treatment
      • Active hepatitis B or C or tuberculosis
      • Positive test for human immunodeficiency virus (HIV) infection
      • Acute or chronic active Epstein-Barr virus (EBV) infection at screening
      • Administration of a live, attenuated vaccine (e.g., FluMist) within 4 weeks before first RO7502175 infusion
      • Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
      • Active or history of autoimmune disease
      • Prior allogeneic stem cell or organ transplantation

      For the latest version of this information please go to www.forpatients.roche.com

       

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      Squamous Cell Carcinoma Advanced Solid Tumors Non-Small Cell Lung Cancer (NSCLC) Triple Negative Breast Cancer Colorectal Cancer (CRC) Gastric Cancer Non Small Cell Lung Carcinoma Urothelial Carcinoma Squamous Cell Carcinoma of the Head and Neck (SCCHN) Esophageal Cancer Hepatocellular Carcinoma (HCC) Metastatic Solid Tumors Malignant Melanoma Clear Cell Renal Cell Carcinoma Melanoma Cervical Cancer

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