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

  • Squamous Cell Carcinoma
  • Gastric Cancer
  • Metastatic Solid Tumors
  • Advanced Solid Tumors
  • Esophageal Cancer
  • Hepatocellular Carcinoma (HCC)
  • Clear Cell Renal Cell Carcinoma
  • Non-Small Cell Lung Cancer
  • Triple Negative Breast Cancer
  • Melanoma
  • Cervical Cancer
  • Urothelial Carcinoma
Trial Status:

Recruiting

This trial runs in
Countries
  • United States
Trial Identifier:

NCT05581004 2021-006708-34 GO43860

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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 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 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, 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, 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 Atezolizumab 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 intending to become pregnant during the study or within 5 months after the final dose of study treatment
      • 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

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