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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

Primary Purpose

Metastatic Solid Tumor, Non-small Cell Lung Cancer, Gastric Cancer

Status
Recruiting
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
RO7496353
Atezolizumab
Capecitabine
S-1
Nivolumab
Oxaliplatin
Nab-paclitaxel
Gemcitabine
Sponsored by
Genentech, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Solid Tumor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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.

Sites / Locations

  • National Cancer Center HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Cohort A: NSCLC

Cohort B: GC

Cohort C: PDAC

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Percentage of Participants with Adverse Events (AEs)
AEs will be reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0).

Secondary Outcome Measures

Plasma Concentration of RO7496353
Cohort A and C: Serum Concentration of Atezolizumab
Percentage of Participants with Anti-Drug Antibody (ADA) to RO7496353
Cohort A and C: Percentage of Participants with ADA to Atezolizumab
Confirmed Objective Response Rate (ORR) as Determined by the Investigator per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
Duration of Response (DOR) as Determined by the Investigator per RECIST v1.1
Progression Free Survival (PFS) as Determined by the Investigator per RECIST v1.1

Full Information

First Posted
May 10, 2023
Last Updated
October 6, 2023
Sponsor
Genentech, Inc.
Collaborators
Chugai Pharmaceutical Co.
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1. Study Identification

Unique Protocol Identification Number
NCT05867121
Brief 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
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 2, 2023 (Actual)
Primary Completion Date
December 30, 2025 (Anticipated)
Study Completion Date
December 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genentech, Inc.
Collaborators
Chugai Pharmaceutical Co.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Solid Tumor, Non-small Cell Lung Cancer, Gastric Cancer, Pancreatic Ductal Adenocarcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cohort A: NSCLC
Arm Type
Experimental
Arm Description
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.
Arm Title
Cohort B: GC
Arm Type
Experimental
Arm Description
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.
Arm Title
Cohort C: PDAC
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
RO7496353
Other Intervention Name(s)
SOF 10
Intervention Description
RO7496353 will be administered as per the schedules specified in the respective arms.
Intervention Type
Drug
Intervention Name(s)
Atezolizumab
Other Intervention Name(s)
RO554126 7; Tecentriq
Intervention Description
Atezolizumab will be administered as per the schedules specified in the respective arms.
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Intervention Description
Capecitabine will be administered as per the schedules specified in the respective arms
Intervention Type
Drug
Intervention Name(s)
S-1
Other Intervention Name(s)
Tegafur/Gimeracil/Oteracil potassium
Intervention Description
S-1 will be administered as per the schedules specified in the respective arms.
Intervention Type
Drug
Intervention Name(s)
Nivolumab
Intervention Description
Nivolumab will be administered as per the schedules specified in the respective arms.
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Intervention Description
Oxaliplatin will be administered as per the schedules specified in the respective arms.
Intervention Type
Drug
Intervention Name(s)
Nab-paclitaxel
Intervention Description
Nab-paclitaxel will be administered as per the schedules specified in the respective arms.
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Description
Gemcitabine will be administered as per the schedules specified in the respective arms.
Primary Outcome Measure Information:
Title
Percentage of Participants with Adverse Events (AEs)
Description
AEs will be reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0).
Time Frame
Up to approximately 29 months
Secondary Outcome Measure Information:
Title
Plasma Concentration of RO7496353
Time Frame
Up to approximately 29 months
Title
Cohort A and C: Serum Concentration of Atezolizumab
Time Frame
Up to approximately 29 months
Title
Percentage of Participants with Anti-Drug Antibody (ADA) to RO7496353
Time Frame
Up to approximately 29 months
Title
Cohort A and C: Percentage of Participants with ADA to Atezolizumab
Time Frame
Up to approximately 29 months
Title
Confirmed Objective Response Rate (ORR) as Determined by the Investigator per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
Time Frame
Up to approximately 29 months
Title
Duration of Response (DOR) as Determined by the Investigator per RECIST v1.1
Time Frame
Up to approximately 29 months
Title
Progression Free Survival (PFS) as Determined by the Investigator per RECIST v1.1
Time Frame
Up to approximately 29 months

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Reference Study ID Number: GO44010 https://forpatients.roche.com/
Phone
888-662-6728 (U.S. Only)
Email
global-roche-genentech-trials@gene.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
National Cancer Center Hospital
City
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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).

Learn more about this trial

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

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