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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

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)
Timepoint [1] 0 0
Up to a maximum of 27 months
Primary outcome [2] 0 0
Percentage of Participants With Dose-limiting Toxicities (DLTs)
Timepoint [2] 0 0
From baseline to 3 weeks on study
Secondary outcome [1] 0 0
Maximum Concentration (Cmax) Derived for RO7567132
Timepoint [1] 0 0
Up to a maximum of 24 months
Secondary outcome [2] 0 0
Time of Maximum Concentration (Tmax)
Timepoint [2] 0 0
Up to a maximum of 24 months
Secondary outcome [3] 0 0
Minimum Concentration (Cmin)
Timepoint [3] 0 0
Up to maximum of 24 Months
Secondary outcome [4] 0 0
Clearance (CL) or Apparent Clearance (CL/F)
Timepoint [4] 0 0
Up to a maximum of 24 months
Secondary outcome [5] 0 0
Volume of Distribution at Steady State (Vss)
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
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
Timepoint [7] 0 0
Up to 24 months
Secondary outcome [8] 0 0
Objective Response Rate (ORR)
Timepoint [8] 0 0
Up to a maximum of 24 months
Secondary outcome [9] 0 0
Disease Control Rate (DCR)
Timepoint [9] 0 0
Up to a maximum of 24 months
Secondary outcome [10] 0 0
Duration of Response (DoR)
Timepoint [10] 0 0
Up to a maximum of 24 months
Secondary outcome [11] 0 0
Progression Free Survival (PFS)
Timepoint [11] 0 0
Up to a maximum of 24 months
Secondary outcome [12] 0 0
Overall Survival (OS)
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)
VIC
Recruitment hospital [1] 0 0
Austin Health - Heidelberg
Recruitment postcode(s) [1] 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
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical trails
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 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)
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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