An Open-Label, Multicenter, Dose-Escalation, Randomized, Phase I Study to Evaluate Safety, Pharmacokinetics, Pharmacodynamics and Anti-Tumor Activity of RO7567132, as a Single Agent and in Combination With Atezolizumab in Participants With Advanced and/or Metastatic Solid Tumors

Study Identifier:
BP44956
CT.gov Identifier:
NCT06537310
EudraCT Identifier:
202451000000
EU Trial (CTIS) Number:
2024-512839-70-00
Study Contact Information:
(210) 593-5651 or [email protected]
Terminated/Withdrawn

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Study Summary

The purpose of this study is to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary clinical activity of RO7567132 as single agent and in combination with atezolizumab. The study will enroll adult participants with selected locally advanced and/or metastatic solid tumors for whom standard therapy does not exist, or has proven to be ineffective or intolerable.

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
    • 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+ years
    Study Drug
  • Drug: Experimental: Part I: RO7567132 Dose Escalation With or Without Atezolizumab
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Terminated/Withdrawn

    Requirements information
    Inclusion criteria
    • Male or female participants aged ≥18 years
    • Body weight > 40 kilograms (kg)
    • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 and Life expectancy of at least 12 weeks
    • Participants with advanced and/or metastatic solid tumors
    • Availability and willingness to provide a mandatory archival tumor specimen or (if not available) a fresh baseline biopsy
    • Negative serum pregnancy test
    • Participants must have adequate cardiovascular, hematological, liver and renal function.
    Exclusion criteria
    • Known central nervous system (CNS) tumors or metastases and leptomeningeal metastases
    • Active second malignancy within 2 years prior to screening
    • History or current clinically significant cardiovascular/cerebrovascular disease
    • Active or history of autoimmune disease
    • Serious, uncontrolled infection
    • Known clinically significant liver disease
    • Unresolved acute toxicity > grade 1 from prior therapy

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Madrid, Spain (FJD)
    Madrid, Spain, 28040
    Investigator
    Victor Moreno Garcia
    Status
    Recruitment Complete
    Condition(s) Treated at Site
    Solid Tumor