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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05867121




Registration number
NCT05867121
Ethics application status
Date submitted
10/05/2023
Date registered
19/05/2023
Date last updated
27/11/2024

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
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
Secondary ID [1] 0 0
2022-502615-11-00
Secondary ID [2] 0 0
GO44010
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic Solid Tumor 0 0
Non-small Cell Lung Cancer 0 0
Gastric Cancer 0 0
Pancreatic Ductal Adenocarcinoma 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
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.
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)
Timepoint [1] 0 0
Up to approximately 29 months
Secondary outcome [1] 0 0
Plasma Concentration of RO7496353
Timepoint [1] 0 0
Up to approximately 29 months
Secondary outcome [2] 0 0
Percentage of Participants with Anti-Drug Antibody (ADA) to RO7496353
Timepoint [2] 0 0
Up to approximately 29 months
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)
Timepoint [3] 0 0
Up to approximately 29 months
Secondary outcome [4] 0 0
Duration of Response (DOR) as Determined by the Investigator per RECIST v1.1
Timepoint [4] 0 0
Up to approximately 29 months
Secondary outcome [5] 0 0
Progression Free Survival (PFS) as Determined by the Investigator per RECIST v1.1
Timepoint [5] 0 0
Up to approximately 29 months

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

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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
2/10/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/12/2025
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA
Recruitment hospital [1] 0 0
St Vincent'S Hospital - Darlinghurst
Recruitment hospital [2] 0 0
Flinders Medical Centre - Bedford Park
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
5042 - Bedford Park
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Connecticut
Country [3] 0 0
United States of America
State/province [3] 0 0
Pennsylvania
Country [4] 0 0
Brazil
State/province [4] 0 0
RS
Country [5] 0 0
Italy
State/province [5] 0 0
Lazio
Country [6] 0 0
Italy
State/province [6] 0 0
Lombardia
Country [7] 0 0
Italy
State/province [7] 0 0
Veneto
Country [8] 0 0
Japan
State/province [8] 0 0
Chiba
Country [9] 0 0
Japan
State/province [9] 0 0
Kanagawa
Country [10] 0 0
Japan
State/province [10] 0 0
Shizuoka
Country [11] 0 0
Japan
State/province [11] 0 0
Tokyo
Country [12] 0 0
Korea, Republic of
State/province [12] 0 0
Seoul
Country [13] 0 0
New Zealand
State/province [13] 0 0
Auckland
Country [14] 0 0
Serbia
State/province [14] 0 0
Beograd-zemun
Country [15] 0 0
Serbia
State/province [15] 0 0
Beograd
Country [16] 0 0
Serbia
State/province [16] 0 0
Kragujevac
Country [17] 0 0
Spain
State/province [17] 0 0
Madrid
Country [18] 0 0
Spain
State/province [18] 0 0
Navarra
Country [19] 0 0
Spain
State/province [19] 0 0
Valencia
Country [20] 0 0
Turkey
State/province [20] 0 0
Ankara
Country [21] 0 0
Turkey
State/province [21] 0 0
Izmir
Country [22] 0 0
Turkey
State/province [22] 0 0
Lzmir

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Genentech, Inc.
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Chugai Pharmaceutical Co.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT05867121
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
Reference Study ID Number: GO44010 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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05867121