Ignite Creation Date:
2024-05-06 @ 3:12 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04551352
Status:
COMPLETED
Last Update Posted:
2022-10-03
First Post:
2020-08-26
Brief Title:
A Study of RO7293583 in Participants With Unresectable Metastatic Tyrosinase Related Protein 1 TYRP1-Positive Melanomas
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
An Open-Label Multicenter Phase 1 Study to Evaluate Safety Tolerability Pharmacokinetics and Pharmacodynamics of RO7293583 A TYRP1-Targeting CD3 T-Cell Engager in Participants With Metastatic Melanoma
Status:
COMPLETED
Status Verified Date:
2022-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a first-in-human multi-center clinical study to determine the safety Maximum Tolerated Dose MTD andor Optimal Biological Dose OBD as well as the optimal schedule for intravenous IV andor subcutaneous SC administrations of RO7293583 with or without obinutuzumab pretreatment in participants with unresectable metastatic TYRP1-positive melanomas who have progressed on standard of care SOC treatment are intolerant to SOC or are non-amenable to SOC This study will include an initial single participant dose-escalation part one followed by a multiple participant dose-escalation part two with the possibility of expansion
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020-000793-18 | EUDRACT_NUMBER | None | None |