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A Clinical Study Evaluating a New Treatment Strategy for Patients With Advanced Pancreatic Cancer Who Have Not Received Prior Treatment for Advanced Disease.

NCT07578337 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-05-13

No results posted yet for this study

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.

Conditions

  • Untreated
  • Advanced Pancreatic Cancer

Interventions

DRUG

Gemcitabine (1000 mg/m2)

Gemcitabine 1,000 mg / m2 IV administered on days 1, 8 and 15 in cycles of 28 days.

DRUG

Nab-paclitaxel (Abraxane)

Nab-P 125 mg / m2 IV administered on days 1, 8 and 15 in cycles of 28 days.

DRUG

NLM-001

NLM-001: 800 mg/day, p.o, once daily (4 tablets of 200 mg) days -4 to -1 and 10-13 of each cycle.

DRUG

Botensilimab

Botensilimab: 75 mg every 6 weeks for 4 administrations, from D1C1.

DRUG

Balstililmab

Balstilimab: 240 mg IV Day 1 and Day 15 of each 28-day cycle.

Sponsors & Collaborators

  • Apices Soluciones S.L.

    collaborator INDUSTRY

  • PH Research, S.L.

    collaborator OTHER

  • Nelum Corp

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-15
Primary Completion
2029-02-28
Completion
2029-02-28

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07578337 on ClinicalTrials.gov