A Randomized Phase II Study of Priming Treatment With the Hedgehog Inhibitor NLM-001 Prior to Gem… (NCT07578337) | Clinical Trial Compass
Not Yet RecruitingPhase 2
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)
Spain40 participantsStarted 2026-07-15
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Investigators must ensure that patients are able to understand the requirements of the study and provide informed consent.
✓. Age ≥18 years.
✓. Histological or cytological diagnosis of pancreatic adenocarcinoma.
✓. Stage IV disease.
✓. No prior treatment for advanced disease. Patients who have received chemotherapy for localized disease are eligible if they progress within six months from the last chemotherapy treatment.
✓. Measurable disease per iRECIST 1.1 as determined by the investigator.
✓. Sufficient hematopoietic, renal and liver function as defined as:
Exclusion criteria
✕. Active or uncontrolled infectious disease or serious medical condition that may interfere with the patient's eligibility or treatment.
What they're measuring
1
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.
. History of psychiatric condition that would compromise the patient's ability to understand or comply with the requirements of the protocol, or the ability to provide informed consent.
✕. Concurrent antineoplastic therapy.
✕. Prior chemotherapy or chemo-radiation therapy for advanced pancreatic cancer.
✕. Prior anti-PD-(L)1 or anti-CTLA-4 as prior therapy(ies).
✕. Pregnant or lactating women.
✕. History of allergic reactions attributed to compounds of similar chemical structure or similar biological study drug composition.
✕. History of life-threatening serious adverse events to Gemcitabine or Nab-Paclitaxel.