Ignite Creation Date:
2024-05-06 @ 4:11 PM
Last Modification Date:
2024-10-26 @ 2:05 PM
Study NCT ID:
NCT04896697
Status:
RECRUITING
Last Update Posted:
2023-08-25
First Post:
2021-05-06
Brief Title:
Vilastobart XTX101 Monotherapy and Vilastobart and Atezolizumab Combination Therapy in Advanced Solid Tumors
Sponsor:
Xilio Development Inc
Organization:
Xilio Development Inc
Study Overview
Official Title:
A First-in-Human Multicenter Phase 12 Open-Label Study of Vilastobart XTX101 Monotherapy and Vilastobart XTX101 and Atezolizumab Combination Therapy in Patients with Advanced Solid Tumors
Status:
RECRUITING
Status Verified Date:
2024-10
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 Phase 12 multicenter open-label study designed to evaluate the safety and tolerability of vilastobart XTX101 as monotherapy and vilastobart XTX101 and atezolizumab combination therapy in patients with advanced solid tumors
Detailed Description:
This is a first-in-human Phase 12 multicenter open-label study designed to evaluate the safety and tolerability of vilastobart XTX101 a tumor-selective anti-CTLA-4 antibody as monotherapy and vilastobart XTX101 and atezolizumab combination therapy in patients with advanced solid tumors
Part 1A will examine vilastobart XTX101 monotherapy in an accelerated and standard 33 dose escalation design Based on the results of Part 1A patients with select advanced solid tumors will be enrolled in Part 1B which will evaluate vilastobart XTX101 monotherapy in relation to specific PD biomarkers
Part 1C will examine vilastobart XTX101 in combination with atezolizumab in a standard 33 dose escalationdose de-escalation design
Phase 2 will examine vilastobart XTX101 in combination with atezolizumab in patients with metastatic microsatellite stable colorectal cancer MSS CRC at the RP2Ds defined in Part 1C
Part 1A will examine vilastobart XTX101 monotherapy in an accelerated and standard 33 dose escalation design Based on the results of Part 1A patients with select advanced solid tumors will be enrolled in Part 1B which will evaluate vilastobart XTX101 monotherapy in relation to specific PD biomarkers
Part 1C will examine vilastobart XTX101 in combination with atezolizumab in a standard 33 dose escalationdose de-escalation design
Phase 2 will examine vilastobart XTX101 in combination with atezolizumab in patients with metastatic microsatellite stable colorectal cancer MSS CRC at the RP2Ds defined in Part 1C
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