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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04827953 | Study to Evaluate the Safety and Efficacy of Treatment With NLM-001 and Standard Chemotherapy Plus Zalifrelimab in Patients With Advanced Pancreatic Cancer | PHASE1 | ACTIVE NOT_RECRUITING | 28 | — | — | Sep 1, 2021 | Apr 1, 2025 | Dec 30, 2024 | 6 | Spain |
Objective Response Rate (ORR): Complete Response (CR) + Partial Response (PR) according to RECIST 1.1 criteria
| Arm | Type | Description |
|---|---|---|
| Investigational treatment | EXPERIMENTAL | Conventional Chemotherapy (Gemcitabine + nab-paclitaxel) plus NLM-001 plus Zalifrelimab |
| Name | Type | Description |
|---|---|---|
| Gemcitabine | DRUG | Gemcitabine 1000 mg/m2 IV on days 1, 8 and 15 (conventional chemotherapy). |
| Nab paclitaxel | DRUG | Nab-Paclitaxel 125 mg/m2 IV on days 1, 8 and 15 (conventional chemotherapy). |
| NLM-001 | DRUG | NLM-001 will be administered three cycles consecutively followed by two rest cycles. |
| Zalifrelimab | DRUG | Zalifrelimab administration each 6 weeks. |
Inclusion Criteria: 1. Investigators must ensure that patients are able to understand the requirements of the study and provide informed consent 2. Age ≥18 years 3. Histological or cytological diagnosis of pancreatic adenocarcinoma 4. Stage IV disease 5. No prior treatment for advanced disease. Pat...