Ignite Creation Date:
2024-05-06 @ 7:01 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05864144
Status:
RECRUITING
Last Update Posted:
2024-05-14
First Post:
2023-04-21
Brief Title:
A Study of SNS-101 Anti VISTA Monotherapy and in Combination With Cemiplimab in Patients With Advanced Solid Tumors
Sponsor:
Sensei Biotherapeutics Inc
Organization:
Sensei Biotherapeutics Inc
Study Overview
Official Title:
A Phase 12 Open-label Study Evaluating the Safety Tolerability Pharmacokinetics Pharmacodynamics and Efficacy of SNS-101 Anti VISTA as Monotherapy and in Combination With Cemiplimab 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:
Phase 12 study to evaluate the safety tolerability pharmacokinetics pharmacodynamics and efficacy of SNS-101 a novel anti VISTA IgG1 monoclonal antibody as monotherapy or in combination with cemiplimab in patients with advanced solid tumors
Detailed Description:
This is a first-in-human Phase 12 open-label multi-center dose escalation and expansion study to evaluate the safety tolerability pharmacokinetics pharmacodynamics and efficacy of SNS-101 a novel anti VISTA IgG1 monoclonal antibody as monotherapy or in combination with cemiplimab in patients with advanced solid tumors
This study is being conducted in three parts
Part A Phase 1 Monotherapy Dose Escalation and Dose Expansion SNS-101 alone
Part B Phase 1 Combination Dose Escalation and Dose Expansion SNS-101 in combination with cemiplimab
Part C Phase 2 Cohort Expansion SNS-101 alone or in combination with cemiplimab
Once the dose escalation portion is complete enrollment will expand to targeted tumor types
Approximately 10 patients with colorectal cancer CRC will be enrolled in the Monotherapy Dose Expansion
o Additional tumor types and doses may be considered upon consultation with the Sponsor
Approximately 50 patients with CRC head and neck cancer HN melanoma and non-small cell lung cancer NSCLC will be enrolled in the Combination Dose Expansion
A minimum of 8 and a maximum of 10 CRC patients will be enrolled in the Combination Dose Expansion
Additional tumor types and doses may be considered upon consultation with the Sponsor
This study is being conducted in three parts
Part A Phase 1 Monotherapy Dose Escalation and Dose Expansion SNS-101 alone
Part B Phase 1 Combination Dose Escalation and Dose Expansion SNS-101 in combination with cemiplimab
Part C Phase 2 Cohort Expansion SNS-101 alone or in combination with cemiplimab
Once the dose escalation portion is complete enrollment will expand to targeted tumor types
Approximately 10 patients with colorectal cancer CRC will be enrolled in the Monotherapy Dose Expansion
o Additional tumor types and doses may be considered upon consultation with the Sponsor
Approximately 50 patients with CRC head and neck cancer HN melanoma and non-small cell lung cancer NSCLC will be enrolled in the Combination Dose Expansion
A minimum of 8 and a maximum of 10 CRC patients will be enrolled in the Combination Dose Expansion
Additional tumor types and doses may be considered upon consultation with the Sponsor
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