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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05129280




Registration number
NCT05129280
Ethics application status
Date submitted
19/11/2021
Date registered
22/11/2021

Titles & IDs
Public title
A Study to Evaluate Safety, Pharmacokinetics, and Preliminary Anti-tumor Activity of RO7444973 in Participants With Unresectable and/or Metastatic MAGE-A4-positive Solid Tumors
Scientific title
An Open-label, Multicenter, Phase I Study to Evaluate Safety, Pharmacokinetics, and Preliminary Anti-tumor Activity of RO7444973 in Participants With Unresectable and/or Metastatic MAGE-A4-positive Solid Tumors
Secondary ID [1] 0 0
2021-000624-35
Secondary ID [2] 0 0
BE43244
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Solid Tumors 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - RO7444973
Treatment: Drugs - Tocilizumab

Experimental: Part I: Single Participant Cohort (SPC) Dose Escalation - In Part I, RO7444973 is administered intravenously (IV) every 3 weeks (Q3W) at a fixed dose in a single participant per dose level.

Experimental: Part II: Multiple Participant Cohort (MPC) Dose Escalation - In Part II, RO7444973 is administered IV Q3W at a fixed dose in multiple participants per dose level. Step-up dosing may also be explored.

Experimental: Part III: Recommended Phase 2 Dose (RP2D) Expansion - Based on emerging data from Part II, an RP2D and dosing regimen will be further investigated in Part III.


Treatment: Drugs: RO7444973
RO7444973 solution for infusion will be administered intravenously at a dose and per schedule as specified for the respective cohort.

Treatment: Drugs: Tocilizumab
Tocilizumab will be used as rescue therapy, in case of clinical presentation of cytokine release syndrome (CRS). Tocilizumab solution for infusion will be administered intravenously at 8 mg/kg for participants \>/= 30 kg or at 12 mg/kg for participants \< 30 kg.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timepoint [1] 0 0
From start of treatment up to 90 days after last RO7444973 dose (up to 15 months)
Primary outcome [2] 0 0
Number of Participants With Dose-limiting Toxicities (DLTs)
Timepoint [2] 0 0
From start of treatment up to 21-28 days
Secondary outcome [1] 0 0
Objective Response Rate (ORR)
Timepoint [1] 0 0
From baseline up to 12 months
Secondary outcome [2] 0 0
Disease Control Rate (DCR)
Timepoint [2] 0 0
From baseline up to 12 months
Secondary outcome [3] 0 0
Duration of Response (DoR)
Timepoint [3] 0 0
From the first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first (up to 40 months)
Secondary outcome [4] 0 0
Progression-free Survival (PFS)
Timepoint [4] 0 0
From baseline to the first occurrence of disease progression or death from any cause, whichever occurs first (up to 40 months)
Secondary outcome [5] 0 0
Overall Survival (OS)
Timepoint [5] 0 0
From baseline to death from any cause (up to 40 months)
Secondary outcome [6] 0 0
Pharmacokinetics (PK): Serum Concentration of RO7444973 Over Time
Timepoint [6] 0 0
From baseline to end of treatment (EoT) visit within 28 days after the last dose (up to 13 months)
Secondary outcome [7] 0 0
Change from Baseline in Percentage of Participants Positive for Anti-drug Antibodies (ADA) to RO7444973
Timepoint [7] 0 0
From baseline to end of treatment (EoT) visit within 28 days after the last dose (up to 13 months)

Eligibility
Key inclusion criteria
Key

* Unresectable and/or metastatic solid tumors that have received standard-of-care (SOC) therapies previously and have no other SOC options available
* Confirmed HLA-A*02:01 haplotype
* Confirmed MAGE-A4 expression
* Radiologically measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
* Life expectancy of >/=12 weeks
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
* Absence of rapid disease progression, threat to vital organs or non-irradiated lesions >2 cm in diameter at critical sites
* No significant ongoing toxicity from prior anticancer treatment
* Adequate hematological function
* Adequate liver function
* Adequate renal function
* If applicable, willingness to use contraceptive measures.

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* History or clinical evidence of CNS primary tumors or metastases
* Another invasive malignancy in the last 2 years
* Uncontrolled hypertension
* Significant cardiovascular disease
* Known active or uncontrolled bacterial, viral, fungal, mycobacterial, parasitic or other infection
* Current or past history of CNS disease
* Dementia or altered mental status that would prohibit informed consent
* Active auto-immune disease or flare within 6 months prior to start of study treatment
* Expected need for regular immunosuppressive therapy or with systemic corticosteroids
* Insufficient washout from prior anti-cancer therapy
* Prior treatment with a bispecific T-cell engaging or adoptive cell therapy.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
25/01/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
12/07/2023
Sample size
Target
Accrual to date
Final
23
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Peter Maccallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 0 0
3000 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Massachusetts
Country [2] 0 0
Belgium
State/province [2] 0 0
Bruxelles
Country [3] 0 0
Belgium
State/province [3] 0 0
Edegem
Country [4] 0 0
Belgium
State/province [4] 0 0
Gent
Country [5] 0 0
Belgium
State/province [5] 0 0
Leuven
Country [6] 0 0
Denmark
State/province [6] 0 0
København Ø
Country [7] 0 0
Spain
State/province [7] 0 0
Barcelona
Country [8] 0 0
Spain
State/province [8] 0 0
Madrid
Country [9] 0 0
United Kingdom
State/province [9] 0 0
Sutton

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 Trials
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


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/NCT05129280