Ignite Creation Date:
2024-05-06 @ 10:50 AM
Last Modification Date:
2024-10-26 @ 12:36 PM
Study NCT ID:
NCT03364348
Status:
COMPLETED
Last Update Posted:
2022-10-19
First Post:
2017-11-10
Brief Title:
4-1BB Agonist Monoclonal Antibody PF-05082566 With Trastuzumab Emtansine or Trastuzumab in Treating Patients With Advanced HER2-Positive Breast Cancer
Sponsor:
George W Sledge Jr
Organization:
Stanford University
Study Overview
Official Title:
A Phase 1B Dose Escalation Trial of Human Anti 4 1BB Agonistic Antibody Utomilumab PF 05082566 in Combination With Ado Trastuzumab Emtansine or Trastuzumab in Patients With HER2 Postive Advanced Breast Cancer
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 trial studies the best dose and side effects of utomilumab 4-1BB agonist monoclonal antibody PF-05082566 with trastuzumab emtansine or trastuzumab in treating patients with HER2-positive breast cancer that has spread to other places in the body Monoclonal antibodies such as utomilumab trastuzumab emtansine and trastuzumab may interfere with the ability of tumor cells to grow and spread
Detailed Description:
PRIMARY OBJECTIVE
Estimate the maximum tolerated dose MTD and determine the recommended dose RP2D of utomilumab in combination with ado-rastuzumab emtansine T-DM1 or trastuzumab in subjects with HER2-positive advanced breast cancer
SECONDARY OBJECTIVES
Determine the objective tumor response ORR
Determine the time to tumor response TTR
Determine the duration of response DR
Determine progression free survival PFS
Assess the safety and tolerability of utomilumab in combination with ado-trastuzumab emtansine or trastuzumab
OUTLINE Patients are randomized to 1 of 2 cohorts
COHORT 1 Dose 1 Utomilumab 20 mg IV ado-trastuzumab emtansine T-DM1 36 mgkg IV every 3 weeks Dose 2 Dose Level 2 - Utomilumab 100 mg IV ado-trastuzumab emtansine 36 mgkg IV every 3 weeks
COHORT 2 Dose 1 Utomilumab 20 mg IV trastuzumab 6 mgkg IV every 3 weeks Dose Level 2 - Utomilumab 100 mg IV trastuzumab 6 mgkg IV every 3 weeks
Estimate the maximum tolerated dose MTD and determine the recommended dose RP2D of utomilumab in combination with ado-rastuzumab emtansine T-DM1 or trastuzumab in subjects with HER2-positive advanced breast cancer
SECONDARY OBJECTIVES
Determine the objective tumor response ORR
Determine the time to tumor response TTR
Determine the duration of response DR
Determine progression free survival PFS
Assess the safety and tolerability of utomilumab in combination with ado-trastuzumab emtansine or trastuzumab
OUTLINE Patients are randomized to 1 of 2 cohorts
COHORT 1 Dose 1 Utomilumab 20 mg IV ado-trastuzumab emtansine T-DM1 36 mgkg IV every 3 weeks Dose 2 Dose Level 2 - Utomilumab 100 mg IV ado-trastuzumab emtansine 36 mgkg IV every 3 weeks
COHORT 2 Dose 1 Utomilumab 20 mg IV trastuzumab 6 mgkg IV every 3 weeks Dose Level 2 - Utomilumab 100 mg IV trastuzumab 6 mgkg IV every 3 weeks
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 |
|---|---|---|---|
| NCI-2016-01881 | REGISTRY | None | None |
| BRS0070 | OTHER | OnCore | None |