Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
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
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05867121
Registration number
NCT05867121
Ethics application status
Date submitted
10/05/2023
Date registered
19/05/2023
Date last updated
16/05/2024
Titles & IDs
Public title
A Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7496353 in Combination With a Checkpoint Inhibitor With or Without Standard-of-Care Chemotherapy in Participants With Locally Advanced or Metastatic Solid Tumors
Query!
Scientific title
A Phase Ib, Open-Label, Multicenter Dose-Expansion Study Evaluating the Safety, Pharmacokinetics, and Activity of RO7496353 in Combination With a Checkpoint Inhibitor With or Without Standard-of-Care Chemotherapy in Patients With Locally Advanced or Metastatic Solid Tumors
Query!
Secondary ID [1]
0
0
2022-502615-11-00
Query!
Secondary ID [2]
0
0
GO44010
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Metastatic Solid Tumor
0
0
Query!
Non-small Cell Lung Cancer
0
0
Query!
Gastric Cancer
0
0
Query!
Pancreatic Ductal Adenocarcinoma
0
0
Query!
Condition category
Condition code
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - RO7496353
Treatment: Drugs - Atezolizumab
Treatment: Drugs - Capecitabine
Treatment: Drugs - S-1
Treatment: Drugs - Nivolumab
Treatment: Drugs - Oxaliplatin
Treatment: Drugs - Nab-paclitaxel
Treatment: Drugs - Gemcitabine
Experimental: Cohort A: NSCLC - Participants with NSCLC will receive RO7496353, and atezolizumab, given as an intravenous (IV) infusion at an assigned dose on Day 1 of each 21-day cycle until unacceptable toxicity or symptomatic deterioration attributed to disease progression.
Experimental: Cohort B: GC - Participants with GC will receive RO7496353, nivolumab, and oxaliplatin, given as an IV infusion at an assigned dose on Day 1 of each 21-day cycle along with either capecitabine or S-1, orally, twice daily on Days 1 to 14 of each cycle until unacceptable toxicity or symptomatic deterioration attributed to disease progression.
Experimental: Cohort C: PDAC - Participants with PDAC will receive RO7496353, and atezolizumab, given as an IV infusion at an assigned dose on Days 1 and 15 of each 28-day cycle along with nab-paclitaxel, and gemcitabine, also given as an IV infusion on Days 1, 8, 15 of each 28-day cycle until unacceptable toxicity or symptomatic deterioration attributed to disease progression.
Treatment: Drugs: RO7496353
RO7496353 will be administered as per the schedules specified in the respective arms.
Treatment: Drugs: Atezolizumab
Atezolizumab will be administered as per the schedules specified in the respective arms.
Treatment: Drugs: Capecitabine
Capecitabine will be administered as per the schedules specified in the respective arms
Treatment: Drugs: S-1
S-1 will be administered as per the schedules specified in the respective arms.
Treatment: Drugs: Nivolumab
Nivolumab will be administered as per the schedules specified in the respective arms.
Treatment: Drugs: Oxaliplatin
Oxaliplatin will be administered as per the schedules specified in the respective arms.
Treatment: Drugs: Nab-paclitaxel
Nab-paclitaxel will be administered as per the schedules specified in the respective arms.
Treatment: Drugs: Gemcitabine
Gemcitabine will be administered as per the schedules specified in the respective arms.
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Percentage of Participants with Adverse Events (AEs)
Query!
Assessment method [1]
0
0
AEs will be reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0).
Query!
Timepoint [1]
0
0
Up to approximately 29 months
Query!
Secondary outcome [1]
0
0
Plasma Concentration of RO7496353
Query!
Assessment method [1]
0
0
Query!
Timepoint [1]
0
0
Up to approximately 29 months
Query!
Secondary outcome [2]
0
0
Percentage of Participants with Anti-Drug Antibody (ADA) to RO7496353
Query!
Assessment method [2]
0
0
Query!
Timepoint [2]
0
0
Up to approximately 29 months
Query!
Secondary outcome [3]
0
0
Confirmed Objective Response Rate (ORR) as Determined by the Investigator per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
Query!
Assessment method [3]
0
0
Query!
Timepoint [3]
0
0
Up to approximately 29 months
Query!
Secondary outcome [4]
0
0
Duration of Response (DOR) as Determined by the Investigator per RECIST v1.1
Query!
Assessment method [4]
0
0
Query!
Timepoint [4]
0
0
Up to approximately 29 months
Query!
Secondary outcome [5]
0
0
Progression Free Survival (PFS) as Determined by the Investigator per RECIST v1.1
Query!
Assessment method [5]
0
0
Query!
Timepoint [5]
0
0
Up to approximately 29 months
Query!
Eligibility
Key inclusion criteria
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy at least 3 months
- Adequate hematologic and end organ function
- Histologically confirmed locally advanced, recurrent, or metastatic incurable solid
tumor malignancy
- Measurable disease according to RECIST v1.1 on computed tomography (CT) or magnetic
resonance imaging (MRI) images within 28 days prior to enrollment
- Availability of representative tumor specimens in formalin-fixed, paraffin-embedded
(FFPE) blocks or at least 15 unstained slides
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
- Pregnant or breastfeeding, or intending to become pregnant during the study or within
9 months after the final dose of oxaliplatin and within 6 months after the final dose
of all other study treatment
- Any anti-cancer therapy, whether investigational or approved, including chemotherapy,
hormonal therapy, and/or radiotherapy, within 3 weeks prior to initiation of study
treatment
- Symptomatic, untreated, or actively progressing central nervous system (CNS)
metastases
- Significant cardiovascular disease (such as New York Heart Association Class II or
greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3
months prior to initiation of study treatment, unstable arrhythmia, or unstable angina
- History of leptomeningeal disease
- Uncontrolled tumor-related pain
- Positive test for human immunodeficiency virus (HIV) infection
- Positive hepatitis B surface antigen (HbsAg) test, and/or positive total hepatitis B
core antibody (HbcAb) test at screening
- Positive hepatitis C virus (HCV) antibody test at screening
- Known allergy or hypersensitivity to any component of the RO7496353 formulation or any
of the study drugs or their excipients
Other protocol-defined inclusion/exclusion criteria may apply.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Non-randomised trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Other
Query!
Other design features
Query!
Phase
Phase 1
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
2/10/2023
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
30/12/2025
Query!
Actual
Query!
Sample size
Target
120
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
NSW,SA
Query!
Recruitment hospital [1]
0
0
St Vincent'S Hospital - Darlinghurst
Query!
Recruitment hospital [2]
0
0
Flinders Medical Centre - Bedford Park
Query!
Recruitment postcode(s) [1]
0
0
2010 - Darlinghurst
Query!
Recruitment postcode(s) [2]
0
0
5042 - Bedford Park
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
California
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Connecticut
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Pennsylvania
Query!
Country [4]
0
0
Brazil
Query!
State/province [4]
0
0
RS
Query!
Country [5]
0
0
Italy
Query!
State/province [5]
0
0
Lazio
Query!
Country [6]
0
0
Italy
Query!
State/province [6]
0
0
Veneto
Query!
Country [7]
0
0
Japan
Query!
State/province [7]
0
0
Chiba
Query!
Country [8]
0
0
Japan
Query!
State/province [8]
0
0
Kanagawa
Query!
Country [9]
0
0
Japan
Query!
State/province [9]
0
0
Shizuoka
Query!
Country [10]
0
0
Japan
Query!
State/province [10]
0
0
Tokyo
Query!
Country [11]
0
0
Korea, Republic of
Query!
State/province [11]
0
0
Seoul
Query!
Country [12]
0
0
New Zealand
Query!
State/province [12]
0
0
Auckland
Query!
Country [13]
0
0
Spain
Query!
State/province [13]
0
0
Madrid
Query!
Country [14]
0
0
Spain
Query!
State/province [14]
0
0
Navarra
Query!
Country [15]
0
0
Spain
Query!
State/province [15]
0
0
Valencia
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Genentech, Inc.
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Other
Query!
Name [1]
0
0
Chugai Pharmaceutical Co.
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
The purpose of this study is to evaluate the safety and tolerability of RO7496353 when
administered in combination with a checkpoint inhibitor (CPI) with or without
standard-of-care (SOC) chemotherapy in participants with locally advanced or metastatic solid
tumors such as non-small cell lung cancer (NSCLC), gastric cancer (GC) and pancreatic ductal
adenocarcinoma (PDAC). The study will be conducted in 2 stages: an initial safety run-in
stage and an expansion stage.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT05867121
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Clinical Trials
Query!
Address
0
0
Hoffmann-La Roche
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Reference Study ID Number: GO44010 https://forpatients.roche.com/
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
888-662-6728 (U.S. Only)
Query!
Fax
0
0
Query!
Email
0
0
[email protected]
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05867121
Download to PDF