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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-000624-35 | EudraCT Number |
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The study was terminated due to program discontinuation.
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This is a first-in-human, open-label, uncontrolled, multi-center, monotherapy dose-escalation and dose expansion study of RO7444973.The aim of this study is to evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of RO7444973 in participants with unresectable and/or metastatic melanoma-associated antigen A4 (MAGE-A4)-positive, solid tumors, carrying the HLA-A*02:01 allele.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part I: Single Participant Cohort (SPC) Dose Escalation | Experimental | In Part I, RO7444973 is administered intravenously (IV) every 3 weeks (Q3W) at a fixed dose in a single participant per dose level. |
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| Part II: Multiple Participant Cohort (MPC) Dose Escalation | Experimental | In Part II, RO7444973 is administered IV Q3W at a fixed dose in multiple participants per dose level. Step-up dosing may also be explored. |
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| Part III: Recommended Phase 2 Dose (RP2D) Expansion | Experimental | Based on emerging data from Part II, an RP2D and dosing regimen will be further investigated in Part III. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RO7444973 | Drug | RO7444973 solution for infusion will be administered intravenously at a dose and per schedule as specified for the respective cohort. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | From start of treatment up to 90 days after last RO7444973 dose (up to 15 months) | |
| Number of Participants With Dose-limiting Toxicities (DLTs) | From start of treatment up to 21-28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | From baseline up to 12 months | |
| Disease Control Rate (DCR) | From baseline up to 12 months | |
| Duration of Response (DoR) |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | United States | ||
| Peter Maccallum Cancer Centre |
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research\_and\_development/who\_we\_are\_how\_we\_work/clinical\_trials/our\_commitment\_to\_data\_sharing.htm).
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| Tocilizumab | Drug | Tocilizumab will be used as rescue therapy, in case of clinical presentation of cytokine release syndrome (CRS). Tocilizumab solution for infusion will be administered intravenously at 8 mg/kg for participants >/= 30 kg or at 12 mg/kg for participants < 30 kg. |
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| From the first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first (up to 40 months) |
| Progression-free Survival (PFS) | From baseline to the first occurrence of disease progression or death from any cause, whichever occurs first (up to 40 months) |
| Overall Survival (OS) | From baseline to death from any cause (up to 40 months) |
| Pharmacokinetics (PK): Serum Concentration of RO7444973 Over Time | From baseline to end of treatment (EoT) visit within 28 days after the last dose (up to 13 months) |
| Change from Baseline in Percentage of Participants Positive for Anti-drug Antibodies (ADA) to RO7444973 | From baseline to end of treatment (EoT) visit within 28 days after the last dose (up to 13 months) |
| Melbourne |
| Victoria |
| 3000 |
| Australia |
| Cliniques Universitaires St-Luc | Brussels | 1200 | Belgium |
| UZ Antwerpen | Edegem | 2650 | Belgium |
| UZ Gent | Ghent | 9000 | Belgium |
| UZ Leuven Gasthuisberg | Leuven | 3000 | Belgium |
| Rigshospitalet; Fase 1 Enhed - Onkologi | København Ø | 2100 | Denmark |
| Vall d?Hebron Institute of Oncology (VHIO), Barcelona | Barcelona | 08035 | Spain |
| Hospital Universitario HM Sanchinarro-CIOCC | Madrid | 28050 | Spain |
| Royal Marsden Hospital - Institute of Cancer Research - Sutton | Sutton | SM2 5PT | United Kingdom |
| ID | Term |
|---|---|
| C502936 | tocilizumab |
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