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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT06372574




Registration number
NCT06372574
Ethics application status
Date submitted
15/04/2024
Date registered
18/04/2024
Date last updated
4/06/2024

Titles & IDs
Public title
A Study of RO7617991 in Patients With Locally Advanced or Metastatic MAGE-A4-Positive Solid Tumors
Scientific title
A Phase I, Open-Label, Multicenter Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Anti-Tumor Activity of RO7617991 in HLA-A*02-Positive Patients With Locally Advanced and/or Metastatic MAGE-A4-Positive Solid Tumors
Secondary ID [1] 0 0
GO44669
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Refractory Cancer 0 0
Recurrent Cancer 0 0
Solid Tumor, Adult 0 0
Condition category
Condition code
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - RO7617991
Treatment: Drugs - Tocilizumab

Experimental: RO7617991 Dose Escalation and Expansion -


Treatment: Drugs: RO7617991
RO7617991 will be administered by intravenous (IV) infusion. Treatment will continue until unacceptable toxicity or loss of clinical benefit as determined by the investigator.

Treatment: Drugs: Tocilizumab
Tocilizumab 8 mg/kg IV will be administered to patients when necessary to treat potential cytokine release syndrome (CRS), as described in the protocol.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence and Severity of Adverse Events
Timepoint [1] 0 0
From first dose until 90 days after the final dose of study treatment (up to approximately 3 years)
Primary outcome [2] 0 0
Number of Participants with Abnormal Values in Targeted Vital Signs
Timepoint [2] 0 0
From Baseline (predose) until 90 days after the final dose of study treatment (up to approximately 3 years)
Primary outcome [3] 0 0
Number of Participants with Abnormal Values in Clinical Laboratory Test Parameters
Timepoint [3] 0 0
From Baseline (predose) until 90 days after the final dose of study treatment (up to approximately 3 years)
Secondary outcome [1] 0 0
Serum Concentration of RO7617991 at Specific Timepoints
Timepoint [1] 0 0
From first dose until 30 days after the final dose of study treatment (up to approximately 3 years)
Secondary outcome [2] 0 0
Objective Response Rate (ORR), as Determined by the Investigator According to RECIST v1.1
Timepoint [2] 0 0
From Baseline until until radiographic disease progression or loss of clinical benefit (up to approximately 3 years)
Secondary outcome [3] 0 0
Duration of Response (DOR), as Determined by the Investigator According to RECIST v1.1
Timepoint [3] 0 0
From first occurrence of a confirmed objective response to disease progression or death, whichever occurs first (up to approximately 3 years)
Secondary outcome [4] 0 0
Progression-Free Survival (PFS), as Determined by the Investigator According to RECIST v1.1
Timepoint [4] 0 0
From enrollment to the first occurrence of disease progression or relapse or death, whichever occurs first (up to approximately 3 years)
Secondary outcome [5] 0 0
Overall Survival (OS)
Timepoint [5] 0 0
From enrollment to death from any cause (up to approximately 3 years)
Secondary outcome [6] 0 0
Prevalence of Anti-Drug Antibodies (ADAs) to RO7617991 at Baseline and Incidence of ADAs to RO7617991 During the Study
Timepoint [6] 0 0
Baseline (predose) and from first dose until 90 days after the final dose of study treatment (up to approximately 3 years)

Eligibility
Key inclusion criteria
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

- Body weight =40 kilograms

- Life expectancy of at least 12 weeks

- Confirmed eligible HLA-A*02 genotype and tumor with confirmed MAGE-A4 expression

- Histologically confirmed locally advanced or metastatic solid tumor malignancy that
has relapsed or is refractory to established therapies

- Measurable disease, according to RECIST v1.1

- Adequate hematologic and end-organ function

- Resolution to Grade =2 of all acute, clinically significant treatment-related toxicity
from prior therapy

- An archival tumor tissue specimen or fresh baseline biopsy (when archival is not
available) is required
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Pregnancy or breastfeeding, or intention of becoming pregnant during the study or
within 3 months after the final dose of RO7617991 or tocilizumab

- Clinically significant cardiopulmonary dysfunction

- Clinically significant liver disease

- Poorly controlled Type 2 diabetes mellitus

- Active hepatitis B or C infection

- Positive test for human immunodeficiency virus (HIV)

- History of allergic reactions to red meat or tick bites or known
galactose-alpha-1,3-galactose (alpha-gal) hypersensitivity

- Symptomatic, untreated, or actively progressing central nervous system (CNS)
metastases

- Symptomatic pleural effusion, pericardial effusion, or ascites or any prior procedural
intervention for pleural effusion, pericardial effusion, or ascites within 6 weeks
prior to enrollment

- Active or history of autoimmune disease or immune deficiency

- Treatment with systemic immunosuppressive medications

- Prior allogeneic stem cell or solid organ transplantation

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/07/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/02/2028
Actual
Sample size
Target
210
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Peter MacCallum Cancer Centre-Box Hill - East Melbourne
Recruitment postcode(s) [1] 0 0
3002 - East Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Genentech, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study will evaluate the safety, tolerability, and pharmacokinetics of RO7617991, and
will make a preliminary assessment of the anti-tumor activity of RO7617991 in human leukocyte
antigen (HLA)-A*02 eligible patients with locally advanced or metastatic melanoma-associated
antigen A4 (MAGE-A4)-positive solid tumors.
Trial website
https://clinicaltrials.gov/ct2/show/NCT06372574
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Genentech, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Reference Study ID Number: GO44669 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
global-roche-genentech-trials@gene.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT06372574