Register a trial

The ANZCTR website is back online for trial registration and updates. We apologise for any inconvenience caused while the site was inactive.


With activity expected to increase on the ANZCTR again, there may be extended wait times while we process pending studies, with priority being given to those trials submitted in February. Thank you for your patience.


Reset your password and enable multi-factor authentication (MFA)


For ANZCTR account holders: to help ensure the cyber safety of your account, you’ll need to reset your password and set-up multi-factor authentication (MFA) as per the instructions below.


  1. Go to the Login page, click ‘reset password’ and follow the instructions.
  2. Check your email for the link to set a new password.
  3. Create a new password that meets requirements.
  4. Return to the Login page and enter your new password. A verification code will be sent to your email.
  5. Check your email for the code and enter it on the Login page. If the code is entered incorrectly, you can re-enter the correct one or request a new one.

Learn more about MFA and its importance on the Australian Signals Directorate website.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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

Titles & IDs
Public title
A Dose-escalation Study of RO7567132 as Single Agent and in Combination With Atezolizumab in Participants With Advanced Solid Tumors
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
Secondary ID [1] 0 0
2024-512839-70-00
Secondary ID [2] 0 0
BP44956
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer-Neoplasms 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants with Adverse Events (AEs) Graded According to Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0)
Assessment method [1] 0 0
Timepoint [1] 0 0
Up to a maximum of 27 months
Primary outcome [2] 0 0
Percentage of Participants With Dose-limiting Toxicities (DLTs)
Assessment method [2] 0 0
Timepoint [2] 0 0
From baseline to 3 weeks on study
Secondary outcome [1] 0 0
Maximum Concentration (Cmax) Derived for RO7567132
Assessment method [1] 0 0
Timepoint [1] 0 0
Up to a maximum of 24 months
Secondary outcome [2] 0 0
Time of Maximum Concentration (Tmax)
Assessment method [2] 0 0
Timepoint [2] 0 0
Up to a maximum of 24 months
Secondary outcome [3] 0 0
Minimum Concentration (Cmin)
Assessment method [3] 0 0
Timepoint [3] 0 0
Up to maximum of 24 Months
Secondary outcome [4] 0 0
Clearance (CL) or Apparent Clearance (CL/F)
Assessment method [4] 0 0
Timepoint [4] 0 0
Up to a maximum of 24 months
Secondary outcome [5] 0 0
Volume of Distribution at Steady State (Vss)
Assessment method [5] 0 0
Timepoint [5] 0 0
Up to a maximum of 24 months
Secondary outcome [6] 0 0
Area Under the Curve (AUC) for Various Time Intervals
Assessment method [6] 0 0
Timepoint [6] 0 0
Up to a maximum of 24 months
Secondary outcome [7] 0 0
Percentage of Participants with Anti-Drug Antibodies (ADAs) to RO7567132
Assessment method [7] 0 0
Timepoint [7] 0 0
Up to 24 months
Secondary outcome [8] 0 0
Objective Response Rate (ORR)
Assessment method [8] 0 0
Timepoint [8] 0 0
Up to a maximum of 24 months
Secondary outcome [9] 0 0
Disease Control Rate (DCR)
Assessment method [9] 0 0
Timepoint [9] 0 0
Up to a maximum of 24 months
Secondary outcome [10] 0 0
Duration of Response (DoR)
Assessment method [10] 0 0
Timepoint [10] 0 0
Up to a maximum of 24 months
Secondary outcome [11] 0 0
Progression Free Survival (PFS)
Assessment method [11] 0 0
Timepoint [11] 0 0
Up to a maximum of 24 months
Secondary outcome [12] 0 0
Overall Survival (OS)
Assessment method [12] 0 0
Timepoint [12] 0 0
Up to a maximum of 24 months

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/09/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
19/06/2029
Actual
Sample size
Target
180
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Kinghorn Cancer Centre - Darlinghurst
Recruitment hospital [2] 0 0
Austin Health - Heidelberg
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
3084 - Heidelberg
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Leuven
Country [2] 0 0
Canada
State/province [2] 0 0
British Columbia
Country [3] 0 0
Canada
State/province [3] 0 0
Ontario
Country [4] 0 0
Canada
State/province [4] 0 0
Quebec
Country [5] 0 0
Denmark
State/province [5] 0 0
København Ø
Country [6] 0 0
Spain
State/province [6] 0 0
Navarra
Country [7] 0 0
Spain
State/province [7] 0 0
Barcelona
Country [8] 0 0
Spain
State/province [8] 0 0
Madrid

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Clinical trails
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Reference Study ID Number: BP44956 https://forpatients.roche.com/
Address 0 0
Country 0 0
Phone 0 0
888-662-6728 (U.S. Only)
Email 0 0
global-roche-genentech-trials@gene.com
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