Clinical trialPhase 2Not yet recruiting
A Clinical Study Evaluating a New Treatment Strategy for Patients With Advanced Pancreatic Cancer Who Have Not Received Prior Treatment for Advanced Disease.
A Randomized Phase II Study of Priming Treatment With the Hedgehog Inhibitor NLM-001 Prior to Gemcitabine/Nab-Paclitaxel (GNab-P) plusBotensilimab and Balstilimab (Bot/Bal) Versus GNab-P in Patients With Previously Untreated Advanced Pancreatic Cancer (NUMANTIA-2)
- Outcome
- Ongoing
- Phase
- Phase 2
- Status
- Not yet recruiting
- Study type
- Interventional
- Start
- 15 July 2026
- Expected end
- 28 February 2029
- Enrollment
- 40 participants
- Sites
- 6
- Primary outcomes
- To evaluate the response rate in each of the study arms, assessed according to iRECIST criteria, including the confirmation of progression to distinguish true progression from potential pseudoprogression.
- Sponsor
- Industry
- Results posted
- No
- Last update
- 13 May 2026
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Brief summary public domain (ClinicalTrials.gov)
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.
Detailed description public domain (ClinicalTrials.gov)
Participants will be centrally randomized 1:1 to one of the study arms. Randomization will be stratified according to: 1. ECOG Performance Status (0 vs 1) 2. Presence of liver metastases (yes vs no)