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 : May 16, 2024
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Sponsor:
Genentech, Inc.
Collaborator:
Chugai Pharmaceutical Co.
Information provided by (Responsible Party):
Genentech, Inc.
Tracking Information | |||||
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First Submitted Date ICMJE | May 10, 2023 | ||||
First Posted Date ICMJE | May 19, 2023 | ||||
Last Update Posted Date | May 16, 2024 | ||||
Actual Study Start Date ICMJE | October 2, 2023 | ||||
Estimated Primary Completion Date | December 30, 2025 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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).
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures |
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Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | 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 ICMJE | 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 ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 | ||||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Sequential Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
120 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | December 30, 2025 | ||||
Estimated Primary Completion Date | December 30, 2025 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply. |
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Australia, Brazil, Italy, Japan, Korea, Republic of, New Zealand, Spain, United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT05867121 | ||||
Other Study ID Numbers ICMJE | GO44010 2022-502615-11-00 ( Other Identifier: EU Clinical Trial Number ) |
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Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Genentech, Inc. | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | Genentech, Inc. | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Chugai Pharmaceutical Co. | ||||
Investigators ICMJE |
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PRS Account | Genentech, Inc. | ||||
Verification Date | May 2024 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |