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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06537310
Registration number
NCT06537310
Ethics application status
Date submitted
1/08/2024
Date registered
5/08/2024
Date last updated
24/06/2025
Titles & IDs
Public title
A Dose-escalation Study of RO7567132 as Single Agent and in Combination With Atezolizumab in Participants With Advanced Solid Tumors
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Scientific title
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
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Secondary ID [1]
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2024-512839-70-00
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Secondary ID [2]
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BP44956
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Cancer-Neoplasms
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - RO7567132 and Atezolizumab
Treatment: Drugs - RO7567132 and Atezolizumab
Experimental: Part I: RO7567132 Dose Escalation With or Without Atezolizumab -
Experimental: Part II: RO7567132 Backfill With Atezolizumab -
Treatment: Drugs: RO7567132 and Atezolizumab
RO7567132 will be administered either as monotherapy or in combination with atezolizumab at a dose and schedule as specified for the respective cohort.
Treatment: Drugs: RO7567132 and Atezolizumab
RO7567132 will be administered in combination with atezolizumab at a dose and schedule as specified for the respective cohort.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants with Adverse Events (AEs) Graded According to Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0)
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Assessment method [1]
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Timepoint [1]
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Up to a maximum of 27 months
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Primary outcome [2]
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Percentage of Participants With Dose-limiting Toxicities (DLTs)
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Assessment method [2]
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Timepoint [2]
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From baseline to 3 weeks on study
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Secondary outcome [1]
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Maximum Concentration (Cmax) Derived for RO7567132
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Assessment method [1]
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Timepoint [1]
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Up to a maximum of 24 months
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Secondary outcome [2]
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Time of Maximum Concentration (Tmax)
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Assessment method [2]
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Timepoint [2]
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Up to a maximum of 24 months
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Secondary outcome [3]
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Minimum Concentration (Cmin)
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Assessment method [3]
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Timepoint [3]
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Up to maximum of 24 Months
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Secondary outcome [4]
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Clearance (CL) or Apparent Clearance (CL/F)
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Assessment method [4]
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Timepoint [4]
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Up to a maximum of 24 months
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Secondary outcome [5]
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Volume of Distribution at Steady State (Vss)
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Assessment method [5]
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Timepoint [5]
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Up to a maximum of 24 months
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Secondary outcome [6]
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Area Under the Curve (AUC) for Various Time Intervals
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Assessment method [6]
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Timepoint [6]
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Up to a maximum of 24 months
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Secondary outcome [7]
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Percentage of Participants with Anti-Drug Antibodies (ADAs) to RO7567132
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Assessment method [7]
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Timepoint [7]
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Up to 24 months
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Secondary outcome [8]
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Objective Response Rate (ORR)
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Assessment method [8]
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Timepoint [8]
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Up to a maximum of 24 months
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Secondary outcome [9]
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Disease Control Rate (DCR)
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Assessment method [9]
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Timepoint [9]
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Up to a maximum of 24 months
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Secondary outcome [10]
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Duration of Response (DoR)
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Assessment method [10]
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Timepoint [10]
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Up to a maximum of 24 months
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Secondary outcome [11]
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Progression Free Survival (PFS)
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Assessment method [11]
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Timepoint [11]
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Up to a maximum of 24 months
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Secondary outcome [12]
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Overall Survival (OS)
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Assessment method [12]
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Timepoint [12]
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Up to a maximum of 24 months
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
16/09/2024
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
19/06/2029
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Actual
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Sample size
Target
180
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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Kinghorn Cancer Centre - Darlinghurst
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Recruitment hospital [2]
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Austin Health - Heidelberg
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Recruitment postcode(s) [1]
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2010 - Darlinghurst
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Recruitment postcode(s) [2]
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3084 - Heidelberg
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Tennessee
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Country [2]
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Belgium
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State/province [2]
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Leuven
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Country [3]
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Canada
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State/province [3]
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British Columbia
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Country [4]
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Canada
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State/province [4]
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Ontario
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Country [5]
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Canada
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State/province [5]
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Quebec
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Country [6]
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Denmark
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State/province [6]
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København Ø
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Country [7]
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France
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State/province [7]
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Toulouse
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Country [8]
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Spain
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State/province [8]
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Navarra
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Country [9]
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Spain
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State/province [9]
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Barcelona
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Country [10]
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Spain
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State/province [10]
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Madrid
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Hoffmann-La Roche
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief 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.
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Trial website
https://clinicaltrials.gov/study/NCT06537310
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Clinical trails
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Address
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Hoffmann-La Roche
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Reference Study ID Number: BP44956 https://forpatients.roche.com/
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Address
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Country
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Phone
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888-662-6728 (U.S. Only)
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06537310
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