Ignite Creation Date:
2024-05-06 @ 12:53 PM
Last Modification Date:
2024-10-26 @ 1:05 PM
Study NCT ID:
NCT03871348
Status:
TERMINATED
Last Update Posted:
2024-03-05
First Post:
2019-01-24
Brief Title:
A First-in-Human Dose Escalation and Expansion Study to Evaluate Intratumoral Administration of SAR441000 as Monotherapy and in Combination With Cemiplimab in Patients With Advanced Solid Tumors
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
A Phase 1 First-in-Human Dose Escalation and Expansion Study for the Evaluation of Safety Pharmacokinetics Pharmacodynamics and Anti-tumor Activity of SAR441000 Administered Intratumorally as Monotherapy and in Combination With Cemiplimab in Patients With Advanced Solid Tumors
Status:
TERMINATED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor terminated the study for non-safety reasons
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Primary Objectives
Dose Escalation To determine maximum tolerated dose MTD or maximum administered dose MAD and overall safety and tolerability profile of SAR441000 when administered intratumorally as monotherapy and in combination with cemiplimab in patients who have no alternative standard treatment options
Dose Expansion Combination To determine the objective response rate of SAR441000 administered intratumorally in combination with cemiplimab in patients with melanoma cutaneous squamous cell carcinoma or head and neck squamous cell carcinoma
Secondary Objectives
To characterize the pharmacokinetic PK profile of SAR441000 administered as monotherapy and in combination with cemiplimab
To assess the immunogenicity of SAR441000
To characterize the safety of SAR441000 when administered intratumorally in combination with cemiplimab
To determine the disease control rate DCR duration of response DoR and progression free survival PFS of SAR441000
To determine the recommended dose of SAR441000 for the expansion phase
Dose Escalation To determine maximum tolerated dose MTD or maximum administered dose MAD and overall safety and tolerability profile of SAR441000 when administered intratumorally as monotherapy and in combination with cemiplimab in patients who have no alternative standard treatment options
Dose Expansion Combination To determine the objective response rate of SAR441000 administered intratumorally in combination with cemiplimab in patients with melanoma cutaneous squamous cell carcinoma or head and neck squamous cell carcinoma
Secondary Objectives
To characterize the pharmacokinetic PK profile of SAR441000 administered as monotherapy and in combination with cemiplimab
To assess the immunogenicity of SAR441000
To characterize the safety of SAR441000 when administered intratumorally in combination with cemiplimab
To determine the disease control rate DCR duration of response DoR and progression free survival PFS of SAR441000
To determine the recommended dose of SAR441000 for the expansion phase
Detailed Description:
The expected duration of treatment for patients who benefit from study intervention may vary based on progression date Median expected duration of study per patient is estimated as 9 months in monotherapy and 12 months in combination therapy
The maximum treatment duration for non-progressive patients is up to 2 years
The maximum treatment duration for non-progressive patients is up to 2 years
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 |
|---|---|---|---|
| U1111-1205-1176 | REGISTRY | None | None |
| 2017-004766-94 | EUDRACT_NUMBER | ICTRP | None |