Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as KYN-175
IK-175 · 1 trial · 21 indications
Proportion of adverse events (AEs) meeting protocol-defined DLT criteria
Frequency of AEs overall, by grade, relationship to study treatment, time-of-onset, duration of the event, duration of resolution, and concomitant medications administered.
| Arm | Type | Description |
|---|---|---|
| IK-175 Single Agent Dose Escalation | EXPERIMENTAL | Approximately 5 dose escalation steps are planned during the Single Agent Treatment dose escalation phase of the study. (COMPLETE) |
| IK-175 Single Agent Dose Expansion | EXPERIMENTAL | A Single Agent Treatment dose expansion phase will be performed in patients with urothelial carcinoma with IK-175 after completion of the dose escalation to confirm the RP2D. (COMPLETE) |
| IK-175 and nivolumab Combination Dose Escalation | EXPERIMENTAL | Approximately 2 dose escalation steps are planned during the Combination Treatment dose escalation phase of the study. (COMPLETE) |
| IK-175 and nivolumab Combination Dose Expansion | EXPERIMENTAL | A Combination Treatment dose expansion phase will be performed in patients with urothelial carcinoma with IK-175 after completion of the dose escalation to confirm the RP2D. (COMPLETE) |
| Name | Type | Description |
|---|---|---|
| IK-175 | DRUG | Subjects will be administered IK-175 PO daily for every 21-day treatment cycle during the Single Agent Treatment dose escalation or for every 28-day treatment cycle during the Single Agent dose expansion. |
| IK-175 and nivolumab | DRUG | Subjects will be administered IK-175 PO daily and administered a single dose of nivolumab IV on Day 1 for every 28-day treatment cycle during the Combination Treatment dose escalation and expansion. |
Inclusion Criteria: 1. Adult patients ≥18 years of age. 2. Patients with confirmed solid tumors (including urothelial carcinoma) who have locally recurrent or metastatic disease that has progressed on or following all standard of care therapies or who is not a candidate for standard treatment. 3. F...
IK-175 is an investigational small molecule AHR inhibitor being developed by ImageneBio, Inc. for urothelial carcinoma and other advanced solid tumors. It is a Phase 1 clinical-stage asset and has not been approved by the FDA. It was studied both as a single agent and in combination with nivolumab.
IK-175 is being studied for locally advanced or metastatic urothelial carcinoma, including bladder cancer, as well as other advanced solid tumors. It is investigational and has not been approved for any indication. The clinical program evaluated it as a single agent and in combination with nivolumab in adults.
IK-175 targets the aryl hydrocarbon receptor, or AHR, and acts as an AHR inhibitor. AHR is a transcription factor involved in immune and tumor microenvironment signaling. By inhibiting AHR, IK-175 is designed to modulate pathways that can suppress antitumor immune responses in solid tumors such as urothelial carcinoma.
IK-175 is being developed by ImageneBio, Inc., which trades under the ticker IMA. The company is the sponsor of the clinical program evaluating the drug in urothelial carcinoma and advanced solid tumors.
IK-175 is in Phase 1 development. Its single clinical trial, NCT04200963, was a Phase 1a/b study that has been completed. The drug remains investigational and has not received FDA approval for urothelial carcinoma or any other indication.
IK-175 was evaluated in one clinical trial, NCT04200963, a Phase 1a/b 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. The trial enrolled 78 patients in the United States and is completed.