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

NCT07578337 | Not Yet Recruiting Phase 2

• 2 other identifiers: NLM-2026-02 / NUMANTIA-22026-525796-90-00
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 6

Brief 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

Keywords

Pancreatic cancer; Cancer; NLM-001

Outcome Measures

Primary Outcomes (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.

  Objective Response Rate (ORR): Complete Response (CR) + Partial Response (PR), according to iRECIST 1.1 criteria, according to investigator criteria. Suspected progression (including possible pseudoprogression due to immune-related effects or new lesions) must be confirmed with repeat imaging performed 4-8 weeks after the initial assessment before considering the patient as having true disease progression.

  12 months

Secondary Outcomes (10)

• To evaluate safety profile and tolerability of study treatment according to NCI-CTCAE v 5.0 criteria.

  12 months

• To evaluate treatment efficacy according to progression free survival (PFS)

  12 months

• To evaluate treatment efficacy according to 6 months PFS

  6 months

• To evaluate treatment efficacy according todisease control rate (DCR)

  12 months

• To evaluate treatment efficacy according to duration of response (DoR)

  12 months

Study Arms (2)

Control Arm

ACTIVE COMPARATOR

Gemcitabine (G): 1,000 mg/m2 Nab-Paclitaxel (Nab-P): 125 mg/m2

Drug: Gemcitabine (1000 mg/m2); Drug: Nab-paclitaxel (Abraxane)

Experimental Arm

EXPERIMENTAL

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

Drug: Gemcitabine (1000 mg/m2); Drug: Nab-paclitaxel (Abraxane); Drug: NLM-001; Drug: Botensilimab; Drug: Balstililmab

Interventions

Nab-paclitaxel (Abraxane) DRUG

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

Control Arm; Experimental Arm

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.

Experimental Arm

Botensilimab DRUG

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

Experimental Arm

Balstililmab DRUG

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

Experimental Arm

Gemcitabine (1000 mg/m2) DRUG

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

Control Arm; Experimental Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• ECOG (Eastern Cooperative Oncology Group) PS 0-1.
• Sufficient hematopoietic, renal and liver function as defined as:
• Neutrophil count ≥ 1.5 x 10\^9 / L
• Platelet count ≥ 100 x 10\^9 / L
• Bilirubin ≤ 1.5 x ULN (upper limit of normal)
• AST and / or ALT ≤2.5 x ULN or ≤5 for patients with liver disease
• Serum creatinine ≤ 1.5 x ULN
• Tumor lesion amenable to safe repeated tumor biopsy.

You may not qualify if:

• Active or uncontrolled infectious disease or serious medical condition that may interfere with the patient's eligibility or treatment.
• 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.
• Patients requiring or being treated with potent CYP3A4 inhibitors and inducers.
• Other active malignancies undergoing or requiring systemic treatment.
• History of interstitial lung disease.
• Subjects with history or presence of a known clotting disorder or difficulty achieving haemostasis will be excluded.
• Primary or secondary immunodeficiency, including immunosuppressive disease or autoimmune disease (including autoimmune endocrinopathies).
• Note: Subjects with type 1 diabetes, vitiligo, psoriasis, hypo-, or hyperthyroid disease not requiring immunosuppressive treatment are eligible. Subjects with Type 2 diabetes mellitus are allowed.
• Subjects with a known history of human immunodeficiency virus 1 and 2, human T lymphotropic virus 1.

Sponsors & Collaborators

• Nelum Corp: lead
• Apices Soluciones S.L.: collaborator
• PH Research, S.L.: collaborator

Study Sites (6)

Hospital Universitario Miguel Servet

Zaragoza, Aragon, Spain

Location

Hospital Clínic Barcelona

Barcelona, Barcelona, Spain

Location

Hospital Universitario Marqués de Valdecilla

Santander, Cantabria, Spain

Location

Hospital Universitario de Donostia

San Sebastián, Gipuzkoa, Spain

Location

Complexo Hospitalario Universitario de Santiago

Santiago de Compostela, La Coruña, Spain

Location

Hospital Universitario Virgen de la Victoria

Málaga, Málaga, Spain

Location

MeSH Terms

Conditions

Pancreatic Neoplasms; Neoplasms

Interventions

Gemcitabine; 130-nm albumin-bound paclitaxel; Albumin-Bound Paclitaxel

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2026
• First Posted: May 11, 2026
• Study Start (Estimated): July 15, 2026
• Primary Completion (Estimated): February 28, 2029
• Study Completion (Estimated): February 28, 2029
• Last Updated: May 13, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (6)