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

Study Identifier:
GO43860
CT.gov Identifier:
NCT05581004
EudraCT Identifier:
2021-006708-34
EU Trial (CTIS) Number:
2023-504709-35-00
Study Contact Information:
(210) 593-5651 or [email protected]
Recruiting

Considering participating in a START clinical trial?

Get Started

Study Summary

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).

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
  • Non-Small Cell Lung Cancer
  • Head & Neck
  • Melanoma
  • Breast Cancers
  • Esophageal
  • Gastric
  • Cervical cancer
  • Bowel (Colorectal)
  • Urinary tract
  • Renal
  • Liver
    • 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
    Sex
    Female & Male
    Age
    18 - 64 Years
    Study Drug
  • Drug: Experimental: Phase Ia: Dose Escalation
    • Read More
  • Drug: Experimental: Phase Ia: Expansion
  • Drug: Experimental: Phase Ib: Dose Escalation
  • Drug: Drug: Atezolizumab
  • Drug: Experimental: Phase Ib: Expansion
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    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

    Clinical Study Information for Healthcare Providers

    By clicking the button below you will find in-depth information about this clinical trial, including study design, primary and secondary endpoints, and more. This information is intended for healthcare professionals seeking to review the scientific and operational aspects of the study.

    View Study Information

    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START San Antonio
    San Antonio, TX, United States, 78229
    Investigator
    Amita Patnaik
    Status
    Recruiting
    Condition(s) Treated at Site
    Solid Tumor
    Non-Small Cell Lung Cancer
    Head & Neck
    Melanoma
    Breast Cancers
    Esophageal
    Gastric
    Cervical cancer
    Bowel (Colorectal)
    Urinary tract
    Renal
    Liver
    Location
    START Madrid, Spain (FJD)
    Madrid, Spain, 28040
    Investigator
    Victor Moreno Garcia
    Status
    Recruiting
    Condition(s) Treated at Site
    Solid Tumor
    Non-Small Cell Lung Cancer
    Head & Neck
    Melanoma
    Breast Cancers
    Esophageal
    Gastric
    Cervical cancer
    Bowel (Colorectal)
    Urinary tract
    Renal
    Liver