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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-004489-21 | EudraCT Number |
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A study to evaluate the safety, pharmacokinetics and anti-tumor activity of RO7300490 as a single agent or in combination with atezolizumab. The study will consist of 3 parts: [Part 1] Dose-Escalation of RO7300490 as a single agent; [Part 2] Dose-Escalation of RO7300490 in combination with atezolizumab and [Part 3] Dose-Expansion of RO7300490 in combination with atezolizumab in selected cancer types.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Dose Escalation (RO7300490 Monotherapy) | Experimental | Participants will receive escalating doses of RO7300490 intravenously (IV) as a single agent for up to 24 months maximum or until progressive disease, unacceptable toxicities, death, or withdrawal of consent. |
|
| Part 2: Dose Escalation (RO7300490/atezolizumab combination therapy) | Experimental | Participants will receive escalating doses of RO7300490 in combination with a fixed dose of atezolizumab IV (as per label) for up to 24 months maximum or until progressive disease, unacceptable toxicities, death, or withdrawal of consent. |
|
| Part 3: Dose Expansion (Disease-specific Expansion(s)) | Experimental | Participants with selected types of advanced and/or metastatic tumors will receive the maximum tolerated dose (MTD) or recommended dose for expansion (RDE) (determined from Parts 1 and 2) of RO7300490 in combination with a fixed dose of atezolizumab IV (as per label). Treatment will be administered for up to 24 months maximum or until progressive disease, unacceptable toxicities, death, or withdrawal of consent. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RO7300490 | Drug | Participants will receive RO7300490, as described in the Arm Descriptions. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with Adverse Events (AEs) (Parts 1 and 2) | Up to 36 months | |
| Percentage of Participants with Dose-Limiting Toxicities (DLTs) (Parts 1 and 2) | Up to 36 months | |
| Objective Response Rate (ORR) (Part 3) | Up to 48 months |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under The Curve (AUC) of RO7300490 (Parts 1, 2 and 3) | Up to 48 months | |
| Minimum Concentration (Cmin) of RO7300490 (Parts 1, 2 and 3) | Up to 48 months | |
| Maximum Concentration (Cmax) of RO7300490 (Parts 1, 2 and 3) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rigshospitalet; Fase 1 Enhed - Onkologi | København Ø | 2100 | Denmark | |||
| Gustave Roussy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42067656 | Derived | Melero I, Reis B, Rusterholz C, Epp A, Kratochwil NA, Wu C, Hettich M, Kazantzidis G, Rieder N, Schwalie PC, Badillo S, Kumpesa N, Thommen A, Vugts DJ, Moreno V, Lostes Bardaji J, Alvarez EC, de Andrea CE, Spanggaard I, Lee DH, Spicer J, Thistlethwaite F, Oh DY, Hollebecque A, Cirovic O, Symeonides SN. Safety and activity of RO7300490, a bispecific CD40 agonist targeted to fibroblast activation protein, in patients with advanced solid tumors: a single-arm, multicenter, first-in-human, phase 1 trial. Nat Cancer. 2026 May;7(5):840-856. doi: 10.1038/s43018-026-01157-8. Epub 2026 May 1. |
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| Atezolizumab | Drug | Participants will receive Atezolizumab, as described in the Arm Descriptions. |
|
| Up to 48 months |
| Clearance (CL) of RO7300490 (Parts 1, 2 and 3) | Up to 48 months |
| Volume of Distribution at Steady State (Vss) of RO7300490 (Parts 1, 2 and 3) | Up to 48 months |
| Percentage of Participants with Anti-RO7300490 Antibodies (Parts 1, 2 and 3) | Up to 48 months |
| Objective Response Rate (ORR) (Parts 1 and 2) | Up to 48 months |
| Disease Control Rate (DCR) (Parts 1, 2 and 3) | Up to 48 months |
| Duration of Response (DOR) (Parts 1, 2 and 3) | Up to 48 months |
| Progression-Free Survival (PFS) On-Treatment (Parts 1, 2 and 3) | Up to 48 months |
| Percentage of Participants With Adverse Events (AEs) (Part 3) | Up to 48 months |
| Villejuif |
| 94805 |
| France |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| Clinica Universitaria de Navarra; Servicio de Oncologia | Pamplona | Navarre | 31008 | Spain |
| Vall d?Hebron Institute of Oncology (VHIO), Barcelona | Barcelona | 08035 | Spain |
| Clinica Universidad de Navarra Madrid; Servicio de Oncología | Madrid | 28027 | Spain |
| START Madrid-FJD, Hospital Fundacion Jimenez Diaz | Madrid | 28040 | Spain |
| Western General Hospital; Edinburgh Cancer Center | Edinburgh | EH4 2XU | United Kingdom |
| Guys and St Thomas Hospital; OHCT Clinical Trials | London | SE1 9RT | United Kingdom |
| Christie Hospital NHS Trust; Experimental Cancer Medicine Team | Manchester | M20 4BX | United Kingdom |
| ID | Term |
|---|---|
| C000594389 | atezolizumab |
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