A Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7496353 in Combination With a Checkpoint Inhibitor With or Without Standard-of-Care Chemotherapy in Participants With Locally Advanced or Metastatic Solid Tumors

  • Pancreatic Ductal Adenocarcinoma
  • Non-Small Cell Lung Cancer
  • Gastric Cancer
  • Metastatic Solid Tumors
Trial Status:

Not yet recruiting

This trial runs in
Countries
Trial Identifier:

NCT05867121 2022-502615-11-00 GO44010

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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

      The purpose of this study is to evaluate the safety and tolerability of RO7496353 when administered in combination with a checkpoint inhibitor (CPI) with or without standard-of-care (SOC) chemotherapy in participants with locally advanced or metastatic solid tumors such as non-small cell lung cancer (NSCLC), gastric cancer (GC) and pancreatic ductal adenocarcinoma (PDAC). The study will be conducted in 2 stages: an initial safety run-in stage and an expansion stage.

      Genentech, Inc. Sponsor
      Phase 1 Phase
      NCT05867121 , GO44010 , 2022-502615-11-00 Trial Identifier
      RO7496353, Atezolizumab, Capecitabine, S-1, Nivolumab, Oxaliplatin, Nab-paclitaxel, Gemcitabine Treatments
      Metastatic Solid Tumor, Non-small Cell Lung Cancer, Gastric Cancer, Pancreatic Ductal Adenocarcinoma Condition
      Official Title

      A Phase Ib, Open-Label, Multicenter Dose-Expansion Study Evaluating the Safety, Pharmacokinetics, and Activity of RO7496353 in Combination With a Checkpoint Inhibitor With or Without Standard-of-Care Chemotherapy in Patients With Locally Advanced or Metastatic Solid Tumors

      Eligibility Criteria

      All Gender
      ≥18 Years Age
      No Healthy Volunteers
      Inclusion Criteria
      • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
      • Life expectancy at least 3 months
      • Adequate hematologic and end organ function
      • Histologically confirmed locally advanced, recurrent, or metastatic incurable solid tumor malignancy
      • Measurable disease according to RECIST v1.1 on computed tomography (CT) or magnetic resonance imaging (MRI) images within 28 days prior to enrollment
      • Availability of representative tumor specimens in formalin-fixed, paraffin-embedded (FFPE) blocks or at least 15 unstained slides
      Exclusion Criteria
      • Pregnant or breastfeeding, or intending to become pregnant during the study or within 9 months after the final dose of oxaliplatin and within 6 months after the final dose of all other study treatment
      • Any anti-cancer therapy, whether investigational or approved, including chemotherapy, hormonal therapy, and/or radiotherapy, within 3 weeks prior to initiation of study treatment
      • Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
      • Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina
      • History of leptomeningeal disease
      • Uncontrolled tumor-related pain
      • Positive test for human immunodeficiency virus (HIV) infection
      • Positive hepatitis B surface antigen (HbsAg) test, and/or positive total hepatitis B core antibody (HbcAb) test at screening
      • Positive hepatitis C virus (HCV) antibody test at screening
      • Known allergy or hypersensitivity to any component of the RO7496353 formulation or any of the study drugs or their excipients

      Other protocol-defined inclusion/exclusion criteria may apply.

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

       

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