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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

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ClinicalTrials.gov Identifier: NCT05867121
Recruitment Status : Recruiting
First Posted : May 19, 2023
Last Update Posted : April 16, 2024
Sponsor:
Collaborator:
Chugai Pharmaceutical Co.
Information provided by (Responsible Party):
Genentech, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Metastatic Solid Tumor Non-small Cell Lung Cancer Gastric Cancer Pancreatic Ductal Adenocarcinoma Drug: RO7496353 Drug: Atezolizumab Drug: Capecitabine Drug: S-1 Drug: Nivolumab Drug: Oxaliplatin Drug: Nab-paclitaxel Drug: Gemcitabine Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : October 2, 2023
Estimated Primary Completion Date : December 30, 2025
Estimated Study Completion Date : December 30, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.
 Drug: RO7496353
RO7496353 will be administered as per the schedules specified in the respective arms.
Other Name: SOF 10

Drug: Atezolizumab
Atezolizumab will be administered as per the schedules specified in the respective arms.
Other Name: RO554126 7; Tecentriq
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.
 Drug: RO7496353
RO7496353 will be administered as per the schedules specified in the respective arms.
Other Name: SOF 10

Drug: Capecitabine
Capecitabine will be administered as per the schedules specified in the respective arms

Drug: S-1
S-1 will be administered as per the schedules specified in the respective arms.
Other Name: Tegafur/Gimeracil/Oteracil potassium

Drug: Nivolumab
Nivolumab will be administered as per the schedules specified in the respective arms.

Drug: Oxaliplatin
Oxaliplatin will be administered as per the schedules specified in the respective arms.
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.
 Drug: RO7496353
RO7496353 will be administered as per the schedules specified in the respective arms.
Other Name: SOF 10

Drug: Atezolizumab
Atezolizumab will be administered as per the schedules specified in the respective arms.
Other Name: RO554126 7; Tecentriq

Drug: Nab-paclitaxel
Nab-paclitaxel will be administered as per the schedules specified in the respective arms.

Drug: Gemcitabine
Gemcitabine will be administered as per the schedules specified in the respective arms.


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants with Adverse Events (AEs) [ Time Frame: Up to approximately 29 months ]
    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 :
  1. Plasma Concentration of RO7496353 [ Time Frame: Up to approximately 29 months ]
  2. Percentage of Participants with Anti-Drug Antibody (ADA) to RO7496353 [ Time Frame: Up to approximately 29 months ]
  3. 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 ]
  4. Duration of Response (DOR) as Determined by the Investigator per RECIST v1.1 [ Time Frame: Up to approximately 29 months ]
  5. Progression Free Survival (PFS) as Determined by the Investigator per RECIST v1.1 [ Time Frame: Up to approximately 29 months ]

Other Outcome Measures:
  1. Cohort A and C: Serum Concentration of Atezolizumab [ Time Frame: Up to approximately 29 months ]
  2. Cohort A and C: Percentage of Participants with ADA to Atezolizumab [ Time Frame: Up to approximately 29 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05867121


Contacts
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Contact: Reference Study ID Number: GO44010 https://forpatients.roche.com/ 888-662-6728 (U.S. Only) global-roche-genentech-trials@gene.com

Locations
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Sponsors and Collaborators
Genentech, Inc.
Chugai Pharmaceutical Co.
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
More Information
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Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT05867121    
Other Study ID Numbers: GO44010
2022-502615-11-00 ( Other Identifier: EU Clinical Trial Number )
First Posted: May 19, 2023    Key Record Dates
Last Update Posted: April 16, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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).

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Adenocarcinoma
Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Paclitaxel
Gemcitabine
Capecitabine
Nivolumab
Oxaliplatin
Atezolizumab
 Tegafur
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antineoplastic Agents, Immunological
Immune Checkpoint Inhibitors