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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04659629 | NL-201 Monotherapy and in Combination With Pembrolizumab in Patients With Relapsed or Refractory Cancer | PHASE1 | COMPLETED | 59 | — | — | Apr 26, 2021 | Aug 15, 2024 | Oct 1, 2024 | 8 | United States, Australia +1 |
Evaluation of tolerability of NL-201 as measured by number of subjects with dose limiting toxicities (DLTs)
Evaluation of tolerability of NL-201 as measured by number of subjects with dose limiting toxicities (DLTs)
Evaluation of tolerability of NL-201 in combination with Pembrolizumab as measured by number of subjects with dose limiting toxicities (DLTs)
Evaluation of tolerability of NL-201 in combination with Pembrolizumab as measured by number of subjects with dose limiting toxicities (DLTs)
Rate of adverse events in patients with advanced solid tumors
Rate of adverse event grades in patients with advanced solid tumors
| Arm | Type | Description |
|---|---|---|
| Part 1: NL-201 Monotherapy Dose Escalation | EXPERIMENTAL | NL-201 given as monotherapy by intravenous administration testing ascending doses and two different schedules. |
| Part 2: NL201 Monotherapy Expansion Cohorts | EXPERIMENTAL | NL-201 given as monotherapy by intravenous administration in indication specific cohorts at a dose and schedule determined in Part 1. |
| Part 3: NL-201 in Combination with Pembrolizumab Dose Escalation | EXPERIMENTAL | NL-201, in combination with a set Pembrolizumab dose, testing ascending doses and two different schedules |
| Part 4: NL-201 in Combination with Pembrolizumab Expansion Cohorts | EXPERIMENTAL | NL-201 in combination with Pembrolizumab in indication specific cohorts at a dose and schedule determined in Part 3 |
| Name | Type | Description |
|---|---|---|
| NL-201 | DRUG | NL-201 is a de novo protein therapeutic. |
| Pembrolizumab Injection [Keytruda] | DRUG | A programmed death receptor-1 (PD-1)-blocking antibody |
Inclusion Criteria: * Patients with measurable disease * Patients with Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * At least 6 weeks from any prior nitrosurea or mitomycin C therapy; at least 4 weeks from any other prior chemotherapy or checkpoint inhibitor; at least 2 w...
| 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 |