| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06873789 | A Study to Evaluate INCB177054 in Participants With Select Advanced or Metastatic Solid Tumors | PHASE1 | ACTIVE NOT_RECRUITING | 9 | — | — | Jun 30, 2025 | May 8, 2026 | Mar 25, 2026 | 9 | United States |
Dose-limiting toxicity will be defined as the occurrence of any of the toxicities as per protocol.
Defined as adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment.
Number of participants with TEAEs leading to dose modification including interruptions, dose reductions, and discontinuation of study drug.
| Arm | Type | Description |
|---|---|---|
| Part 1a: Dose Escalation monotherapy | EXPERIMENTAL | INCB177054 at the protocol-defined dose strength based on cohort assignment. |
| Part 1b: Pharmacodynamic cohort | EXPERIMENTAL | INCB177054 at the protocol-defined dose strength based on cohort assignment. |
| Part 1c: Dose Expansion monotherapy | EXPERIMENTAL | INCB177054 at the protocol-defined dose strength based on cohort assignment. |
| Part 2a: Dose Escalation combination | EXPERIMENTAL | INCB177054 in combination with retifanlimab at the protocol-defined dose strength based on cohort assignment. |
| Part 2b: Dose Expansion combination | EXPERIMENTAL | INCB177054 in combination with retifanlimab at the protocol-defined dose strength based on cohort assignment. |
| Name | Type | Description |
|---|---|---|
| INCB177054 | DRUG | INCB177054 will be administered at protocol defined dose. |
| Retifanlimab | DRUG | Retifanlimab will be administered at protocol defined dose. |
Inclusion Criteria: * Anticipated life expectancy greater than 12 weeks. * ECOG performance status score of 0 or 1. * Measurable disease per RECIST v1.1 on CT or MRI. * Part 1a and 2a (dose escalation) and Part 1c (dose expansion): participants who have a confirmed tissue diagnosis of a solid malig...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 2 | PHASE2 | pembrolizumab, V503, GARDASIL |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| AstraZeneca PLC | AZN | 1 | — | Trastuzumab deruxtecan |