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Active (not recruiting) Phase 1 NCT06537310

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

Phase 1 – testing safety in a small group of people
Conditions: Cancer-Neoplasms

Sponsor: Hoffmann-La Roche

trial.available_in: БГ
Overview
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.
Who can participate
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 5
Australia (1)
Kinghorn Cancer Centre
Darlinghurst , New South Wales
Belgium (1)
UZ Leuven Gasthuisberg
Leuven
Canada (1)
BC Cancer ? Vancouver
Vancouver , British Columbia
Denmark (1)
Rigshospitalet
København Ø
Spain (1)
Clinica Universidad de Navarra
Pamplona , Navarre
Technical details
Status
Active (not recruiting)
Phase
Phase 1
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
16.09.2024
Completion date
10.08.2027
Registry ID
NCT06537310
Source
anzctr
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