A Study to Evaluate Safety, Pharmacokinetics and Anti-Tumor Activity of RO7300490, as Single Agent or in Combination With Atezolizumab in Participants With Advanced Solid Tumors

Last updated: February 2, 2024
Sponsor: Hoffmann-La Roche
Overall Status: Completed

Phase

1

Condition

Neoplasms

Solid Tumors

Treatment

Atezolizumab

RO7300490

Clinical Study ID

NCT04857138
WP42627
2020-004489-21
  • Ages > 18
  • All Genders

Study Summary

A study to evaluate the safety, pharmacokinetics and anti-tumor activity of RO7300490 as a single agent or in combination with atezolizumab. The study will consist of 3 parts: [Part 1] Dose-Escalation of RO7300490 as a single agent; [Part 2] Dose-Escalation of RO7300490 in combination with atezolizumab and [Part 3] Dose-Expansion of RO7300490 in combination with atezolizumab in selected cancer types.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Life expectancy of >= 12 weeks.
  • Histologically confirmed diagnosis of locally advanced and/or metastatic solid tumorsthat are not amenable to standard therapy.
  • Radiologically measurable disease as defined by Response Evaluation Criteria in SolidTumors (RECIST) v1.1.
  • Agreement to provide protocol-specific biopsy material.
  • Adverse Events (AEs) from prior anti-cancer therapy resolved to Grade =<1.
  • Adequate performance status and cardiovascular, hematological, liver, renal andcoagulation function.
  • For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse), use contraceptive measures and refrain fromdonating eggs.
  • For male participants: agreement to remain abstinent (refrain from heterosexualintercourse), use contraceptive measures and refrain from donating sperm.

Exclusion

Exclusion Criteria:

  • Known central nervous system (CNS) primary tumors or metastases, includingleptomeningeal metastases, unless protocol-specific conditions are met.
  • Active second invasive malignancy within two years prior to screening.
  • Significant cardiovascular/cerebrovascular disease within 6 months prior to studytreatment start.
  • Any other diseases, metabolic dysfunction, physical examination finding or clinicallaboratory finding that gives reasonable suspicion of a disease or condition thatwould contraindicate the use of an investigational drug.
  • Prior allogeneic bone marrow transplantation or prior solid organ transplantation.
  • Active or history of autoimmune disease.
  • Known hypersensitivity to any of the components of RO7300490 formulation or tocomponents of atezolizumab formulation.
  • Pregnancy, lactation or breastfeeding.
  • Dementia or altered mental status that would prohibit informed consent.
  • Major surgery or significant traumatic injury within 28 days prior to the first studydrug administration (excluding biopsies) or anticipation of the need for major surgeryduring study treatment.
  • Treatment with radiotherapy, chemotherapy, hormonal therapy, targeted therapy,immunotherapy or investigational drug concurrent or within 28 days or 5 half-lives ofthe drug (whichever is shorter) before the first study drug administration.

Study Design

Total Participants: 80
Treatment Group(s): 2
Primary Treatment: Atezolizumab
Phase: 1
Study Start date:
May 18, 2021
Estimated Completion Date:
January 18, 2024

Connect with a study center

  • Rigshospitalet; Fase 1 Enhed - Onkologi

    København Ø, 2100
    Denmark

    Site Not Available

  • Gustave Roussy

    Villejuif, 94805
    France

    Site Not Available

  • Gustave Roussy

    Villejuif CEDEX, 94800
    France

    Site Not Available

  • Asan Medical Center

    Seoul, 05505
    Korea, Republic of

    Site Not Available

  • Seoul National University Hospital

    Seoul, 03080
    Korea, Republic of

    Site Not Available

  • Clinica Universitaria de Navarra; Servicio de Oncologia

    Pamplona, Navarra 31008
    Spain

    Site Not Available

  • Vall d?Hebron Institute of Oncology (VHIO), Barcelona

    Barcelona, 08035
    Spain

    Site Not Available

  • Clinica Universidad de Navarra Madrid; Servicio de Oncología

    Madrid, 28027
    Spain

    Site Not Available

  • START Madrid-FJD, Hospital Fundacion Jimenez Diaz

    Madrid, 28040
    Spain

    Site Not Available

  • Western General Hospital; Edinburgh Cancer Center

    Edinburgh, EH4 2XU
    United Kingdom

    Site Not Available

  • Guys and St Thomas Hospital; OHCT Clinical Trials

    London, SE1 9RT
    United Kingdom

    Site Not Available

  • Christie Hospital NHS Trust; Experimental Cancer Medicine Team

    Manchester, M20 4BX
    United Kingdom

    Site Not Available

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