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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-509266-38-00 | EU Trial (CTIS) Number |
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This is a first-in-human Phase I, open-label, dose-escalation and expansion study designed to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamic, and preliminary anti-tumor activity of RO7566802 as a single agent and in combination with atezolizumab in participants with locally advanced, recurrent, or metastatic incurable solid tumor malignancies. Participants will be enrolled in 2 stages: dose escalation and expansion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Escalation Cohort | Experimental | Participants in successive cohorts will receive escalating doses of RO7566802, as an intravenous (IV) infusion on Day 1 of each 21-day cycle followed by RO7566802 in combination with a fixed dose of atezolizumab, as an IV infusion on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity. |
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| Dose Expansion Cohort | Experimental | Participants with select solid tumors will receive a recommended dose of RO7566802, determined in Dose Escalation phase, as an IV infusion in combination with a fixed dose of atezolizumab, as an IV infusion on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RO7566802 | Drug | RO7566802 solution for infusion will be administered as specified in each treatment arm. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Dose-limiting Toxicity (DLTs) | Cycle 1 Day 1 through 21 days after Cycle 2 Day 1 (Cycle length=21 days) (up to approximately 42 days) | |
| Percentage of Participants with Adverse Events (AEs) Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE v5.0) | Up to approximately 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Serum Concentration Time Curve (AUC) of RO7566802 | Up to approximately 4 years | |
| Maximum Serum Concentration (Cmax) of RO7566802 | Up to approximately 4 years | |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Reference Study ID Number: GO44431 https://forpatients.roche.com/ | Contact | 888-662-6728 (U.S. Only) | global-roche-genentech-trials@gene.com | |
| Fastest response: use the inquiry form. No email attachments. https://www.gene.com/contact-us/submit-medical-inquiry | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham (UAB) | Recruiting | Birmingham | Alabama | 35233 | United States | |
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| Label | URL |
|---|---|
| Please use this form to submit your questions for a faster response: https://www.gene.com/contact-us/submit-medical-inquiry. Do not include or attach any medical records when emailing or completing the form. A nurse will respond within 24 business hours. | View source |
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| Atezolizumab | Drug | Atezolizumab solution for infusion will be administered as specified in each treatment arm. |
|
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| Minimum Serum Concentration (Cmin) of RO7566802 |
| Up to approximately 4 years |
| Total Clearance (CL) of RO7566802 | Up to approximately 4 years |
| Volume of Distribution at Steady State (Vss) of RO7566802 | Up to approximately 4 years |
| Serum Concentration of Atezolizumab | Up to approximately 4 years |
| Objective Response Rate as Determined by Investigator According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) | Up to approximately 4 years |
| Percentage of Participants with Anti-Drug Antibodies (ADAs) to RO7566802 | From Baseline up to approximately 4 years |
| Yale Cancer Center |
| Recruiting |
| New Haven |
| Connecticut |
| 06520 |
| United States |
| Icahn School of Medicine at Mount Sinai (ISMMS) | Recruiting | New York | New York | 10029 | United States |
| The Ohio State University | Recruiting | Columbus | Ohio | 43221-3502 | United States |
| Magee-Woman's Hospital | Recruiting | Harrisburg | Pennsylvania | 17109 | United States |
| SCRI Oncology Partners | Recruiting | Nashville | Tennessee | 37203 | United States |
| St Vincent's Hospital Sydney | Recruiting | Darlinghurst | New South Wales | 2010 | Australia |
| Peter Maccallum Cancer Centre | Recruiting | Melbourne | Victoria | 3000 | Australia |
| British Columbia Cancer Agency - 600 10th Ave W | Recruiting | Vancouver | British Columbia | V5Z 4E6 | Canada |
| Princess Margaret Cancer Centre | Recruiting | Toronto | Ontario | M5G 1Z5 | Canada |
| National University Hospital | Recruiting | Singapore | 119074 | Singapore |
| National Cancer Centre | Recruiting | Singapore | 168583 | Singapore |
| Addenbrooke's Hospital | Recruiting | Cambridge | CB2 0QQ | United Kingdom |
| Leicester Royal Infirmary | Recruiting | Leicester | LE1 5WW | United Kingdom |
| St Bartholomew's Hospital | Recruiting | London | EC1A 7BE | United Kingdom |
| Sarah Cannon Research Institute | Recruiting | London | W1G 6AD | United Kingdom |
| Churchill Hospital | Recruiting | Oxford | OX3 7LJ | United Kingdom |
| The Royal Marsden hospital | Recruiting | Sutton | SM2 5PT | United Kingdom |
| ID | Term |
|---|---|
| C000594389 | atezolizumab |
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