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

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

Tracking Information

• First Submitted Date: May 10, 2023
• First Posted Date: May 19, 2023
• Last Update Posted Date: May 16, 2024
• Actual Study Start Date: October 2, 2023
• Estimated Primary Completion Date: December 30, 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 10, 2023)

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).

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: March 19, 2024)

• Plasma Concentration of RO7496353 [ Time Frame: Up to approximately 29 months ]
• Percentage of Participants with Anti-Drug Antibody (ADA) to RO7496353 [ Time Frame: Up to approximately 29 months ]
• 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 ]
• Duration of Response (DOR) as Determined by the Investigator per RECIST v1.1 [ Time Frame: Up to approximately 29 months ]
• Progression Free Survival (PFS) as Determined by the Investigator per RECIST v1.1 [ Time Frame: Up to approximately 29 months ]

Original Secondary Outcome Measures (submitted: May 10, 2023)

• Plasma Concentration of RO7496353 [ Time Frame: Up to approximately 29 months ]
• Cohort A and C: Serum Concentration of Atezolizumab [ Time Frame: Up to approximately 29 months ]
• Percentage of Participants with Anti-Drug Antibody (ADA) to RO7496353 [ Time Frame: Up to approximately 29 months ]
• Cohort A and C: Percentage of Participants with ADA to Atezolizumab [ Time Frame: Up to approximately 29 months ]
• 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 ]
• Duration of Response (DOR) as Determined by the Investigator per RECIST v1.1 [ Time Frame: Up to approximately 29 months ]
• Progression Free Survival (PFS) as Determined by the Investigator per RECIST v1.1 [ Time Frame: Up to approximately 29 months ]

Current Other Pre-specified Outcome Measures (submitted: March 19, 2024)

• Cohort A and C: Serum Concentration of Atezolizumab [ Time Frame: Up to approximately 29 months ]
• Cohort A and C: Percentage of Participants with ADA to Atezolizumab [ Time Frame: Up to approximately 29 months ]

• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Non-Randomized; Intervention Model: Sequential Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Metastatic Solid Tumor
• Non-small Cell Lung Cancer
• Gastric Cancer
• Pancreatic Ductal Adenocarcinoma

Intervention

• 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: 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.
• 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.

Study Arms

• 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.
  Interventions:

  • Drug: RO7496353
  • Drug: Atezolizumab
• 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.
  Interventions:

  • Drug: RO7496353
  • Drug: Capecitabine
  • Drug: S-1
  • Drug: Nivolumab
  • Drug: Oxaliplatin
• 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.
  Interventions:

  • Drug: RO7496353
  • Drug: Atezolizumab
  • Drug: Nab-paclitaxel
  • Drug: Gemcitabine

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: May 10, 2023): 120
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 30, 2025
• Estimated Primary Completion Date: December 30, 2025 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All
• Gender Based Eligibility: Yes

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

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

• Listed Location Countries: Australia, Brazil, Italy, Japan, Korea, Republic of, New Zealand, Spain, United States

Administrative Information

• NCT Number: NCT05867121
• Other Study ID Numbers: GO44010; 2022-502615-11-00 ( Other Identifier: EU Clinical Trial Number )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

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).

• Current Responsible Party: Genentech, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Genentech, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Chugai Pharmaceutical Co.

Investigators

• Study Director: Clinical Trials; Hoffmann-La Roche

• PRS Account: Genentech, Inc.
• Verification Date: May 2024