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

Sponsor
Nelum Corp
Study ID
NCT07578337
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Advanced Pancreatic Cancer
  • Untreated

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Gemcitabine (1000 mg/m2) — DRUG
    Gemcitabine 1,000 mg / m2 IV administered on days 1, 8 and 15 in cycles of 28 days.
  • Nab-paclitaxel (Abraxane) — DRUG
    Nab-P 125 mg / m2 IV administered on days 1, 8 and 15 in cycles of 28 days.
  • NLM-001 — DRUG
    NLM-001: 800 mg/day, p.o, once daily (4 tablets of 200 mg) days -4 to -1 and 10-13 of each cycle.
  • Botensilimab — DRUG
    Botensilimab: 75 mg every 6 weeks for 4 administrations, from D1C1.
  • Balstililmab — DRUG
    Balstilimab: 240 mg IV Day 1 and Day 15 of each 28-day cycle.

Study Details

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.

Key Dates

Start date
Jul 15, 2026
Status verified
May 2026
Primary completion
Feb 28, 2029
Completion
Feb 28, 2029

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Control Arm
    Gemcitabine (G): 1,000 mg/m2 Nab-Paclitaxel (Nab-P): 125 mg/m2
  • Experimental: Experimental Arm
    NLM-001: 800 mg/day Gemcitabine (G): 1,000 mg/m2 Nab-Paclitaxel (Nab-P): 125 mg/m2 Botensilimab (Bot, CTLA-4 inhibitor): 75 mg Balstilimab (Bal, PD-1 inhibitor): 240 mg

Primary Outcome Measure

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. [ Time Frame: 12 months ]