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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-512839-70-00 | Other Identifier | EU Trial Number |
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The purpose of this study is to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary clinical activity of RO7567132 as single agent and in combination with atezolizumab. The study will enroll adult participants with selected locally advanced and/or metastatic solid tumors for whom standard therapy does not exist, or has proven to be ineffective or intolerable.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part I: RO7567132 Dose Escalation With or Without Atezolizumab | Experimental |
| |
| Part II: RO7567132 Backfill With Atezolizumab | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RO7567132 and Atezolizumab | Drug | RO7567132 will be administered either as monotherapy or in combination with atezolizumab at a dose and schedule as specified for the respective cohort. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with Adverse Events (AEs) Graded According to Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0) | Up to a maximum of 27 months | |
| Percentage of Participants With Dose-limiting Toxicities (DLTs) | From baseline to 3 weeks on study |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Concentration (Cmax) Derived for RO7567132 | Up to a maximum of 24 months | |
| Time of Maximum Concentration (Tmax) | Up to a maximum of 24 months | |
| Minimum Concentration (Cmin) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical trails | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kinghorn Cancer Centre | Darlinghurst | New South Wales | 2010 | Australia | ||
| Austin Health |
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| RO7567132 and Atezolizumab | Drug | RO7567132 will be administered in combination with atezolizumab at a dose and schedule as specified for the respective cohort. |
|
| Up to maximum of 24 Months |
| Clearance (CL) or Apparent Clearance (CL/F) | Up to a maximum of 24 months |
| Volume of Distribution at Steady State (Vss) | Up to a maximum of 24 months |
| Area Under the Curve (AUC) for Various Time Intervals | Up to a maximum of 24 months |
| Percentage of Participants with Anti-Drug Antibodies (ADAs) to RO7567132 | Up to 24 months |
| Objective Response Rate (ORR) | Up to a maximum of 24 months |
| Disease Control Rate (DCR) | Up to a maximum of 24 months |
| Duration of Response (DoR) | Up to a maximum of 24 months |
| Progression Free Survival (PFS) | Up to a maximum of 24 months |
| Overall Survival (OS) | Up to a maximum of 24 months |
| Heidelberg |
| Victoria |
| 3084 |
| Australia |
| UZ Leuven Gasthuisberg | Leuven | 3000 | Belgium |
| BC Cancer ? Vancouver | Vancouver | British Columbia | V5Z 4E6 | Canada |
| Princess Margaret Cancer Center | Toronto | Ontario | M5G 2M9 | Canada |
| McGill University Health Center | Montreal | Quebec | H4A 3J1 | Canada |
| Rigshospitalet | København Ø | 2100 | Denmark |
| Clinica Universidad de Navarra | Pamplona | Navarre | 31008 | Spain |
| Vall d?Hebron Institute of Oncology (VHIO), Barcelona | Barcelona | 08035 | Spain |
| Clinica Universidad de Navarra Madrid | Madrid | 28027 | Spain |
| Fundacion Jimenez Diaz | Madrid | 28040 | Spain |
| ID | Term |
|---|---|
| C000594389 | atezolizumab |
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