Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 being studied for the treatment of urothelial carcinoma, a type of bladder cancer. It is also being evaluated in patients with locally advanced or metastatic solid tumors. The drug is currently in Phase 1 clinical development and is not yet approved by the FDA.
IK-175 is being developed by ImageneBio, Inc., a biopharmaceutical company traded under the ticker symbol IMA. The company is conducting clinical research to evaluate the safety and efficacy of this investigational drug in oncology.
IK-175 is in Phase 1 clinical development. It has completed one Phase 1 trial, which was a single-arm, open-label study. The drug is still investigational and has not been approved by regulatory authorities for any indication.
IK-175 has been studied in one clinical trial with the identifier NCT04200963. This was a Phase 1a/b study evaluating 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 participants and has been completed.
IK-175 is a small molecule designed to target specific pathways involved in cancer. However, the exact molecular target or mechanism of action has not been disclosed in the available information. The drug is being investigated for its potential to treat urothelial carcinoma and other solid tumors.