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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06035744 | CLN-617 Alone and in Combination With Pembrolizumab in Patients With Advanced Solid Tumors | PHASE1 | RECRUITING | 86 | — | — | Dec 12, 2023 | Jun 1, 2028 | Mar 3, 2025 | 5 | United States |
Number of treatment-emergent events (TEAEs): TEAE is defined as adverse events reported for the first time or worsening of a pre-existing event after the first dose of study drug.
Number of treatment-emergent events (TEAEs): TEAE is defined as adverse events reported for the first time or worsening of a pre-existing event after the first dose of study drug.
Overall Response Rate (ORR): The % of patients having a CR or PR as determined by PI assessment of disease response per iRECIST
| Arm | Type | Description |
|---|---|---|
| CLN-617 Dose Escalation (Part A) | EXPERIMENTAL | Patients with Advanced Solid Tumors enrolled in dose escalation cohorts treated with CLN-617 alone and in combination with pembrolizumab |
| CLN-617 Dose Optimization (Part B) | EXPERIMENTAL | Patients with Advanced Solid Tumors enrolled in dose optimization receiving selected doses of CLN-617 in combination with pembrolizumab |
| CLN-617 Dose Expansion (Part C) | EXPERIMENTAL | Patients with Advanced Melanoma or Head and Neck Squamous Cell Carcinoma (HNSCC) enrolled in dose expansion treated with CLN-617 in combination with pembrolizumab |
| Name | Type | Description |
|---|---|---|
| CLN-617 | DRUG | Single-chain fusion protein comprised of human IL-2, human LAIR2, HSA, and human IL-12, connected via glycine/serine linker sequences |
| Pembrolizumab | DRUG | Humanized IgG4 anti-PD-1 monoclonal antibody |
Inclusion Criteria: 1. Aged ≥ 18 years. 2. Patient should have previously received or had a contraindication to standard therapy that confers an overall survival benefit. 3. Part 1 Dose Escalation Cohorts: Histologically or cytologically confirmed advanced incurable or metastatic non-neurological s...
| 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 |