Ignite Creation Date:
2024-10-25 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06634875
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-07
Brief Title:
Isunakinra Alone and in Combination with Pembrolizumab in Patients with Colorectal Cancer MSS
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase IIa Non-Randomized Open-Label Dose Expansion Trial of Isunakinra in Combination with Pembrolizumab in Patients with Metastatic or Unresectable Locally Advanced Colorectal Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will enroll patients with colorectal cancer that is locally advanced or metastatic The tumor must be microsatellite stable MSS have a tumor mutational burden that is high TMB-H and be kras mutated Patients must have been treated with available approved treatments already In this study the investoigators are testing a new type of immunotherapy aclled isunakinra to be added to already approved immunotherapy PD-1PD-L1 inhibitor in an attempt to get this otherwise effective treatment to work on this treatment resistant type of tumor
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None