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UntreatedPhase 2NUMANTIA-2NCT07578337

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

A Phase 2 study testing Gemcitabine (1000 mg/m2), Nab-paclitaxel (Abraxane) and NLM-001 in people with Untreated and Advanced Pancreatic Cancer, run by Nelum Corp at 6 sites in Spain.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Untreated, Advanced Pancreatic Cancer
What is being tested?
Gemcitabine (1000 mg/m2), Nab-paclitaxel (Abraxane) and NLM-001
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
6 sitesSpain
Study dates
15 Jul 2026to 28 Feb 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.
  • Women of child-bearing age and men who wish to participate in the study must agree to use appropriate contraceptive methods from the signing of informed consent until 6 months for women and 3 months for men after discontinuation of the study drug o Adequate contraception includes abstinence, oral contraceptives, transdermal patches, and injections that prolong release of a progestogen (starting at least 4 weeks prior to the administration of the investigational drug), condom or female condom (diaphragm or condom / vaginal) plus spermicide, intrauterine device (IUD), implant or a vaginal ring (placed at least 4 weeks prior to administration of investigational drug) or male partner sterilization (vasectomy with documentation of azoospermia) before the inclusion of the woman in the trial if the male is the only sex partner of the woman (see appendix G).

Who cannot join

  • 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.
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  • 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.
  • Prior treatment with anticancer therapies, immunosuppressive agents, corticosteroids, radiation, investigational drugs or vaccines within the following time intervals before the first dose of study treatment (C1D1):
  • Cytotoxic chemotherapy: within 3 weeks prior to C1D1. (ii) Monoclonal antibodies, antibody-drug conjugates or radioimmunoconjugates: within 4 weeks or 5 half-lives, whichever is shorter.
  • Small-molecule targeted therapies, including tyrosine kinase inhibitors: within 2 weeks or 5 half-lives, whichever is shorter.
  • Any other anti-neoplastic therapy (including experimental agents): within 3 weeks, except:
  • Investigational drugs or devices must not have been administered within 21 days or 5 half-lives (whichever is longer).
  • For investigational agents with long half-lives (>5 days), earlier enrolment requires approval by the medical monitor.
  • Radiotherapy: - A 1-week washout is permitted for palliative radiation to non-CNS lesions, with medical monitor approval.
  • Patients must not have experienced radiation pneumonitis or be receiving chronic corticosteroids for this condition.
  • Corticosteroids: - No systemic corticosteroids within 7 days, except:
  • inhaled or topical corticosteroids,
  • corticosteroid premedication for contrast allergy,
  • physiologic replacement doses, with medical monitor approval. (vii) Immunosuppressive therapies: - No immunosuppressive treatment within 7 days, except for the permitted corticosteroid uses listed above.
  • SARS-CoV-2 vaccination:
  • No COVID-19 vaccine within 7 days before randomization.
  • When feasible, multi-dose vaccine series should be completed prior to randomization.
  • Has not recovered to grade ≤1 from toxic effects of prior therapy and/or complications from prior surgical intervention before starting therapy.
  • Note: Subjects with grade ≤2 neuropathy and alopecia are an exception and may enroll.
  • History or presence of an abnormal ECG that, in the investigator's opinion, is clinically meaningful.
  • Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke or myocardial infarction within 6 months of study enrollment, unstable angina, congestive heart failure (New York Heart Association class ≥ III), or serious uncontrolled cardiac arrhythmia requiring medication.
  • QTcF (QT interval corrected using Fridericia's formula) of > 480 ms.
  • Concurrent participation in other investigational drug trials.
  • Known central nervous system (CNS) involvement as follows:
  • Untreated CNS metastases.
  • Leptomeningeal metastases. Note: Patients may be eligible if CNS metastases have been treated and patients have neurologically returned to baseline (except for residual signs and symptoms related to the CNS treatment).
  • Known to be positive for hepatitis B virus (HBV) surface antigen, or any other positive test for HBV indicating acute or chronic infection. Participants who are receiving or who have received anti-HBV therapy and have undetectable HBV DNA for at least 6 months prior to study enrollment are eligible. Serological testing for HBV at screening is not required.
  • Known active hepatitis C virus (HCV) as determined by positive serology and confirmed by polymerase chain reaction (PCR). Participants on or who have received antiretroviral therapy are eligible provided they are virus-free by PCR for at least 6 months prior to study enrollment. Serological testing for HCV at screening is not required.

Trial locations and contacts

6 sites in 1 country. Contact the study team or a site near you to ask about taking part.

6 sites in 1 country

Spain6 sites

  • Hospital Clínic Barcelona

    Barcelona, Barcelona

    Teresa Macarulla, MD

    Teresa Macarulla, MD

  • Hospital Universitario Virgen de la Victoria

    Málaga, Málaga

    Laura Medina, MD

    Laura Medina, MD

  • Hospital Universitario de Donostia

    San Sebastián, Gipuzkoa

    Aitziber Gil-Negrete, MD

    Aitziber Gil-Negrete, MD

  • Hospital Universitario Marqués de Valdecilla

    Santander, Cantabria

    Fernando Rivera, MD

    Fernando Rivera, MD

  • Complexo Hospitalario Universitario de Santiago

    Santiago de Compostela, La Coruña

    Elena María Brozos, MD

    Elena María Brozos, MD

  • Hospital Universitario Miguel Servet

    Zaragoza, Aragon

    Roberto Pazo, MD

    Roberto Pozo, MD

Other trials in Spain

About this study

Official title: 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)

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.

Read the detailed description

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)
Being tested
Gemcitabine (1000 mg/m2), Nab-paclitaxel (Abraxane), NLM-001, Botensilimab, Balstililmab
Keywords
Pancreatic cancer, Cancer, NLM-001
Medical subject headings
Pancreatic Neoplasms, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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-001Drug

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

  • BotensilimabDrug

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

  • BalstililmabDrug

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

Study groups in NCT07578337
Study groupRoleWhat they receive
Control ArmActive comparatorGemcitabine (G): 1,000 mg/m2 Nab-Paclitaxel (Nab-P): 125 mg/m2
Receives: Drug: Gemcitabine (1000 mg/m2); Drug: Nab-paclitaxel (Abraxane)
Experimental ArmExperimentalNLM-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
Receives: Drug: Gemcitabine (1000 mg/m2); Drug: Nab-paclitaxel (Abraxane); Drug: NLM-001; Drug: Botensilimab; Drug: Balstililmab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 12 months

Secondary outcomes (10)

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

    Safety profile will be assessed according to NCI-CTCAE v 5.0 criteria. The number of patients experiencing each AE will be summarized by CTCAE grade.

    Measured: 12 months

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

    Progression Free Survival (PFS): PFS is defined as the time in months from the patient's randomization until patient progression according to iRECIST 1.1 criteria or death.

    Measured: 12 months

  3. To evaluate treatment efficacy according to 6 months PFS

    Progression Free Survival (PFS): PFS is defined as the time in months from the patient's randomization until patient progression according to iRECIST 1.1 criteria or death.

    Measured: 6 months

  4. To evaluate treatment efficacy according todisease control rate (DCR)

    Disease Control Rate (DCR): Complete Response (CR) + Partial Response (PR) + Stable Disease (SD) evaluated by iRECIST 1.1 criteria according to investigator criteria.

    Measured: 12 months

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

    Duration of Response (DoR): DoR is defined as the time in months from the date of first documented objective response (complete response [CR] or partial response [PR], whichever is first) until the date of first documented disease progression or death from any cause, whichever occurs first.

    Measured: 12 months

  6. To evaluate treatment efficacy according to duration of clinical benefit (DoCB)

    Duration of Clinical Benefit (DoCB): DoCB is defined, for subjects achieving clinical benefit (complete response [CR], partial response [PR], or stable disease [SD] per iRECIST v1.1), as the time from the date of first documented evidence of clinical benefit (CR, PR, or SD) until the date of first documented radiographic disease progression or death from any cause, whichever occurs first.

    Measured: 12 months

  7. To evaluate treatment efficacy according to overall survival.

    Overall Survival (OS): OS is defined as the time in months from the patient's randomization until death.

    Measured: 12 months

  8. To evaluate CA 19.9 levels during study treatment (Decrease > 50%)

    Decrease in CA 19.9 levels > 50%. Responses based on levels of the tumor marker CA 19.9 will be calculated as the maximum percentage of change with respect to baseline in those patients with a baseline higher than 1.25 times the upper limit of normal in the local laboratory of each center.

    Measured: 12 months

  9. To evaluate CA 19.9 levels during study treatment (Decrease > 75%)

    Decrease in CA 19.9 levels > 75%. Responses based on levels of the tumor marker CA 19.9 will be calculated as the maximum percentage of change with respect to baseline in those patients with a baseline higher than 1.25 times the upper limit of normal in the local laboratory of each center.

    Measured: 12 months

  10. To evaluate CA 19.9 levels during study treatment (Decrease > 90%).

    Decrease in CA 19.9 levels > 90%. Responses based on levels of the tumor marker CA 19.9 will be calculated as the maximum percentage of change with respect to baseline in those patients with a baseline higher than 1.25 times the upper limit of normal in the local laboratory of each center.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 May 2026
  2. Study start15 Jul 2026 (estimated)
  3. Primary completion28 Feb 2029 (estimated)
  4. Study completion28 Feb 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07578337
Sponsor's protocol ID
NLM-2026-02 / NUMANTIA-2
Other IDs
2026-525796-90-00
Acronym
NUMANTIA-2
Status last verified
May 2026
First submitted
5 May 2026
Last updated
13 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Gemcitabine (1000 mg/m2), Nab-paclitaxel (Abraxane) and NLM-001 in people with Untreated and Advanced Pancreatic Cancer, run by Nelum Corp at 6 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 41 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07578337.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.

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