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A Dose-escalation Study of RO7567132 as Single Agent and in Combination With Atezolizumab in Participants With Advanced Solid Tumors
A Dose-escalation Study of RO7567132 as Single Agent and in Combination With Atezolizumab in Participants With Advanced Solid Tumors

NCT06537310

Active Not RecruitingPhase 1

Sponsor: Hoffmann-La Roche

Conditions: Cancer-Neoplasms

Interventions: RO7567132 and Atezolizumab, RO7567132 and Atezolizumab

Countries: Australia, Belgium, Canada, Denmark, Spain

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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
Locations (10)
  • Darlinghurst, New South Wales, Australia
  • Heidelberg, Victoria, Australia
  • Leuven, Belgium
  • Vancouver, British Columbia, Canada
  • Toronto, Ontario, Canada
  • Montreal, Quebec, Canada
  • København Ø, Denmark
  • Barcelona, Spain
  • Madrid, Spain
  • Madrid, Spain