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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-513391-17-00 | EU Trial (CTIS) Number |
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Following a thorough review of safety data, preliminary efficacy data and an evaluation of overall risk-benefit, Sponsor made the decision to end the study.
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This is a first-in-human Phase Ia/Ib, open-label, multicenter, dose escalation and dose expansion study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary anti-tumor activity of RO7759065 as a single agent (Phase Ia) or in combination with atezolizumab (Phase Ib) in patients with locally advanced, recurrent, or metastatic incurable solid tumor malignancies. Several key aspects of the study design and study population are summarized below.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase Ia: Dose Escalation | Experimental |
| |
| Phase Ia: Expansion | Experimental |
| |
| Phase Ib: Dose Escalation | Experimental |
| |
| Phase Ib: Expansion | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RO7759065 | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants iwth Dose Limiting Toxicity (DLTs) | Up to approximately 5 years | |
| Number of Participants with Adverse Events (AEs) | Up to approximately 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Serum Concentration (Cmax) of RO7759065 | Up to approximately 5 years | |
| Objective Response Rate (ORR) | Up to Approximately 5 Years | |
| Duration of Response (DOR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Genentech, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope Comprehensive Cancer Center | Duarte | California | 91010 | United States | ||
| University of Colorado |
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| Atezolizumab | Drug | Specified dose on specified days |
|
| Up to approximately 5 years |
| Progression Free Survival (PFS) | Up to approximately 5 years |
| Percentage of Participants With Anti-Drug Antibodies (ADAs) to RO7759065 | Up to approximately 5 years |
| Aurora |
| Colorado |
| 80045-2517 |
| United States |
| Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | 08901 | United States |
| Tennesse Oncology - NASH - SCRI - PPDS | Chattanooga | Tennessee | 37404-1130 | United States |
| St Vincent's Hospital Sydney | Darlinghurst | New South Wales | 2010 | Australia |
| British Columbia Cancer Agency | Vancouver | British Columbia | V5Z 4R2 | Canada |
| Princess Margaret Cancer Centre | Toronto | Ontario | M5G 2MR | Canada |
| Sir Mortimer B Davis Jewish General Hospital-3755 Cote Sainte-Catherine | Montreal | Quebec | H3T 1E2 | Canada |
| Clinica Universidad de Navarra | Pamplona | Navarre | 31008 | Spain |
| Clinica Universidad de Navarra-Madrid | Madrid | 28027 | Spain |
| Hospital Clinico Universitario de Valencia | Valencia | 46010 | Spain |
| ID | Term |
|---|---|
| C000594389 | atezolizumab |
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