Ignite Creation Date:
2024-05-06 @ 2:03 PM
Last Modification Date:
2024-10-26 @ 1:24 PM
Study NCT ID:
NCT04200963
Status:
COMPLETED
Last Update Posted:
2024-03-15
First Post:
2019-12-11
Brief Title:
A Phase 1ab Study of IK-175 as a Single Agent and in Combination With Nivolumab in Patients With Locally Advanced or Metastatic Solid Tumors and Urothelial Carcinoma
Sponsor:
Ikena Oncology
Organization:
Ikena Oncology
Study Overview
Official Title:
A Phase 1ab Open-Label Dose-Escalation and Expansion Study of IK-175 an Oral Aryl Hydrocarbon Receptor AHR Inhibitor as a Single Agent and in Combination With Nivolumab a PD-1 Checkpoint Inhibitor in Patients With Locally Advanced or Metastatic Solid Tumors and Urothelial Carcinoma
Status:
COMPLETED
Status Verified Date:
2024-03
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 study will be conducted in adult subjects diagnosed with any form of an advanced or metastatic solid tumors including urothelial carcinoma for which standard therapy is no longer effective or is intolerable This is a phase 1 multi-center open label study designed to assess safety and tolerability of IK-175 as a single agent and in combination with nivolumab to determine the recommended phase 2 dose RP2D Disease response pharmacokinetics PK pharmacodynamics and response biomarkers will also be assessed
Detailed Description:
None
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 |
|---|---|---|---|
| KYN-175 | OTHER | Ikena Oncology | None |