Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | PHASE1 | COMPLETED | 78 | — | — | Dec 18, 2019 | Jul 18, 2023 | Mar 15, 2024 | 10 | United States |
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...