drugset / Trial / NCT07578337
A Clinical Study Evaluating a New Treatment Strategy for Patients With Advanced Pancreatic Cancer Who Have Not Received Prior Treatment for Advanced Disease.
Phase 2
Not yet recruiting
40 enrolled
Nelum Corp
Apices Soluciones S.L. · collabPH Research, S.L. · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
Phase II, open label, randomized multicenter study to evaluate efficacy and safety of study treatment in previously untreated patients with advanced pancreatic cancer. Patients will receive study treatment for a maximum of 24 months or until progression disease or until unacceptable toxicity. In the experimental arm, patients who discontinue chemotherapy for reasons other than disease progression may continue receiving the remaining study drugs (NLM-001, botensilimab and balstilimab) up to a maximum of 24 months, according to schedule.
Timeline
- Start
- 2026-07-15
- Primary completion
- 2029-02-28
- Completion
- 2029-02-28
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Balstilimab | Monoclonal antibody | 240 mg | Intravenous |
| Subject | Botensilimab | Monoclonal antibody | 75 mg | — |
| Subject | NLM-001 | Unknown | 800 mg | Oral |
| Background | Gemcitabine | Small molecule | 1000 mg/m2 | Intravenous |
| Background | Paclitaxel | Small molecule | 125 mg/m2 | Intravenous |