Ignite Creation Date:
2024-05-06 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06208124
Status:
RECRUITING
Last Update Posted:
2024-04-15
First Post:
2024-01-05
Brief Title:
A Study of IMM-6-415 in RASRAF Mutant Solid Tumors
Sponsor:
Immuneering Corporation
Organization:
Immuneering Corporation
Study Overview
Official Title:
A Phase 12a Study of IMM-6-415 in Participants With Advanced or Metastatic Malignancies Harboring RAS or RAF Oncogenic Mutations
Status:
RECRUITING
Status Verified Date:
2024-09
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 FIH ascending dose study to characterize the safety tolerability optimal dose and preliminary anti-tumor activity of IMM-6-415 in participants with advanced or metastatic solid tumors harboring RAS or RAF oncogenic mutations
Detailed Description:
The dose exploration will identify the candidate recommended Phase 2 dose RP2D of IMM-6-415 to further explore the anti-tumor activity of IMM-6-415 as monotherapy in Phase 2a tumor-specific cohorts Patients will be self-administering IMM-6-415 on a daily basis for up to 16 cycles 21-day cycles During the first 2 cycles PK and PD will be assessed Solid tumor types with RASRAF mutations are eligible
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