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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04580485 | INCB106385 Alone or in Combination With Immunotherapy in Advanced Solid Tumors | PHASE1 | COMPLETED | 54 | — | — | Feb 3, 2021 | Jan 22, 2024 | Jul 11, 2025 | 27 | United States, Belgium +4 |
Defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug up to 90 days after last dose of study drug.
| Arm | Type | Description |
|---|---|---|
| Treatment Group A (TGA) - INCB106385 | EXPERIMENTAL | In part 1 dose escalation, the dose levels will be escalated following a BOIN design. In part 2 dose expansion, participants will be assigned to different groups based on their tumor types and treated at the RDE. |
| Treatment Group B (TGB) - INCB106385+INCMGA00012 | EXPERIMENTAL | In part 1 dose escalation, the dose levels will be escalated following a BOIN design. In part 2 dose expansion, participants will be assigned to different groups based on their tumor types and treated at the RDE. |
| Name | Type | Description |
|---|---|---|
| INCB106385 | DRUG | INCB106385 will be administered orally QD |
| INCMGA00012 | DRUG | INCMGA0012 will be administered IV once every 4 weeks (Q4W) |
Inclusion Criteria: * Ability to comprehend and willingness to sign an ICF. * Willing and able to conform to and comply with all Protocol requirements. * Histologically or cytologically confirmed advanced/metastatic SCCHN, NSCLC, ovarian cancer, TNBC, CRPC, bladder cancer, and specified GI malignan...