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Pancreatic Ductal AdenocarcinomaPhase 1LAP-NET1NCT05546853

Study Investigating the Association of NP137 With mFOLFIRINOX in Locally Advanced Pancreatic Ductal Adenocarcinoma

A Phase 1 study testing NP137, Oxaliplatin and Irinotecan in people with Pancreatic Ductal Adenocarcinoma, run by University Hospital, Grenoble at 9 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The study will assess the safety of the association of NP137 with the standard of care mFOLFIRINOX in the treatment of locally advanced pancreatic ductal adenocarcinoma.The study drug which is tested is the NP137 in association with mFOLFIRINOX to allow a better tumor response as well as better survival outcomes with… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Ductal Adenocarcinoma
What is being tested?
NP137, Oxaliplatin and Irinotecan
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
43 participants
Where
9 sitesFrance
Study dates
28 Mar 2023to 16 Jun 2025
Phase
Phase 1
Are there results?
None posted in the registry

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

  • Age from 18 to 79 years
  • Able to understand and sign informed consent
  • Histologically or cytologically proven diagnosis of pancreatic ductal adenocarcinoma
  • Locally advanced pancreatic cancer considered unresectable according to NCCN Guidelines® Version 2.2021
  • Measurable disease as defined by Response Evaluation Criteria in Solid Tumors RECIST 1.1 criteria
  • Male, or non-pregnant and non-lactating female
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  • Women patients of childbearing potential* must have a negative serum/urine pregnancy test at screening and baseline, and be willing to use a highly effective** contraception. The patient should be advised to continue the contraception for at least 6 months following the completion of dosing. Women with cessation for \> 24 months of previously occurring menses, or women of any age who have had a hysterectomy, or have had both ovaries removed will be considered to be of non-childbearing potential
  • Male patients of reproductive potential must be willing to use one acceptable method of contraception, as judged by Investigator and Sponsor and/or to refrain from donating sperm from the time of screening through at least 6 months following the completion of dose administration
  • No prior systemic therapy, radiation therapy, or resection for pancreatic cancer
  • Life expectancy ≥ 12 weeks
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Adequate liver function:
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 2.5 x upper limit of normal (ULN),
  • Bilirubin ≤ 1.5 x ULN or in subjects with biliary stenting ≤ 2.0 x ULN
  • Alkaline phosphatase \< 2.5 x ULN
  • Subjects with biliary stenting do not need to wait for their alkaline phosphatase to become \< 2.5 x ULN if their total bilirubin, AST and ALT have improved to within required study levels with criteria 12a and 12b
  • Adequate bone marrow function: platelets \>100,000 cells/mm3, hemoglobin \> 9.0 g/dl and absolute neutrophil count (ANC) \>1,500 cells/mm3
  • Adequate renal function: creatinine \< 1.5 x ULN, creatinine clearance ≥ 30 mL/min/m2
  • Adequate nutritional state with Albumin ≥ 2.5 g/dL
  • Less than grade 2 pre-existing peripheral neuropathy (per CTCAE)
  • Patients covered by Health Insurance System

Who cannot join

  • Patients with resectable pancreatic cancer
  • Evidence of the presence of metastases.
  • Patients who have received prior systemic therapy, radiation therapy, or resection for pancreatic cancer or prior therapy with NP137
  • Patients with known Dihydropyrimidine dehydrogenase (DPD) deficiency, or homozygosity for UGT1A1*28 polymorphism (UGT1A1 genotype analysis is not required to be eligible)
  • Previous (within the past 3 years) or concurrent malignancy diagnosis except non-melanoma skin cancer and in situ carcinomas (excluding in situ breast cancer)
  • History of severe (grade ≥ 3) allergic reactions to one of the components of chemotherapy, or NP137
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  • Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, may decrease subject's compliance to study's procedures or may render the patient at high risk from treatment complications in the opinion of the treating investigator
  • Subjects with known poorly controlled comorbid conditions, including; congestive heart failure (CHF), chronic obstructive pulmonary disease (COPD), uncontrolled diabetes mellitus (DM) or neurologic disorders (not acutely related to pancreatic cancer) or limited function
  • Major surgery within 4 weeks prior to signing informed consent form. Biliary stents are permitted
  • History of allergy or hypersensitivity to human, humanized or chimeric monoclonal antibodies
  • History of allergy or hypersensitivity to any of the chemotherapy agents belonging to mFOLFIRINOX regimen
  • Subjects with a history of chronic HCV, HBV or HIV infection
  • Subjects who have been administered a live vaccine within four weeks prior to the first administration of therapy
  • Subjects who cannot stop chronic medications that inhibit or induce CYP2C8 or CYP3A4
  • Persons referred to in Articles L1121-5 to L1121-8 of the French code of public health (this corresponds to all persons protected: pregnant or parturient women, breastfeeding mothers, persons deprived of liberty by judicial or administrative decision, persons subject to a legal protection measure)
  • Patients who have active infection requiring systemic therapy (other than HCV, HBV, HIV).
  • Patients who participate or plan to participate in another interventional clinical trial or who is in exclusion period for another study.

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

France9 sites

  • CHU de BORDEAUX

    Bordeaux, 33404

  • CHU de GRENOBLE ALPES

    Grenoble, Alpes, 38043

  • CHRU Lille

    Lille, 59037

  • Hôpital Privé Jean Mermoz

    Lyon, 69008

  • AP-HP Pitié Salpetrière

    Paris, 75013

  • CHU Poitiers

    Poitiers, 86000

  • CHU de REIMS

    Reims, 51092

  • CHU Rennes

    Rennes, 35033

  • CHU St Etienne

    Saint-Etienne, 42055

Other trials in France

About this study

The study will assess the safety of the association of NP137 with the standard of care mFOLFIRINOX in the treatment of locally advanced pancreatic ductal adenocarcinoma.The study drug which is tested is the NP137 in association with mFOLFIRINOX to allow a better tumor response as well as better survival outcomes with an acceptable safety.

Read the detailed description

The study is a multicentric, prospective, single arm phase 1b trial. This study will enroll 43 to 52 patients and consists of 2 parts: Safety Lead-in Phase and Expansion Phase. Initially, 3 to 12 patients will be enrolled into a Safety Lead-in Phase based on a 3 + 3 design, with the possibility of dose de-escalation, to confirm the recommended dose of NP137.The Expansion Phase will start after completion of Safety Lead-in Phase at the confirmed dose and will include 40 patients. Patients will be assigned to the experimental arm (NP137 + mFOLFIRINOX).

Being tested
NP137, Oxaliplatin, Irinotecan, Calcium levofolinate, 5 FU

What participants receive

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

  • NP137Drug

    NP137 will be administrated at the first day of each cycle (CnD1) of 14 days as an IV infusion at 9 or 14 mg/kg.

  • OxaliplatinDrug

    Oxaliplatin will be administreted at the first day of each cycle (CnD1) of 14 days as an IV infusion at 85 mg/m²

  • IrinotecanDrug

    Irinotecan will be administreted at the first day of each cycle (CnD1) of 14 days as an IV infusion at 150 mg/m²

  • Calcium levofolinateDrug

    Calcium levofolinate will be administreted at the first day of each cycle (CnD1) of 14 days as an IV infusion at 100 mg/m²

  • 5 FUDrug

    5 FU will be administreted at the first day of each cycle (CnD1) of 14 days as an IV infusion at 2400 mg/m2 as a continuous intravenous infusion over 46 hours.

Study groups in NCT05546853
Study groupRoleWhat they receive
ExperimentalExperimentalNP137+ mFOLFIRINOX
Receives: Drug: NP137; Drug: Oxaliplatin; Drug: Irinotecan; Drug: Calcium levofolinate; Drug: 5 FU

What is being measured

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

  1. Percentage Proportion of patients experiencing adverse events

    Percentage Proportion of patients experiencing adverse events (AEs) of any grade and grade 3/4 AEs as defined by the National Cancer Institute - Common Terminology Criteria for Adverse Events (CTCAE v 5.0) at 6 months.

    Measured: At 6 months

Secondary outcomes (10)

  1. Best overall objective response rate (ORR)

    Best overall objective response rate (ORR) and ORR at 3 months, 6, 9, 12 months according to RECIST 1.1

    Measured: At 3,6,9 and 12 months

  2. Overall survival (OS)

    Median Overall survival (OS), 6 months and 12 months-OS rates. OS is defined as the time between inclusion and death (all causes). Patients alive will be censored at the date of last news.

    Measured: at 6, 12 and 36 months

  3. Progression-Free Survival (PFS)

    Median Progression-Free Survival (PFS), 6 months and 12 months-PFS rates. PFS is defined as the time between inclusion and progression according to RECIST 1.1 or death (all causes). Patients alive without progression will be censored at the date of last news.

    Measured: at 6, 12 and 36 months

  4. Median Duration of response

    Median Duration of response is defined as the time between first dose of treatment and progression according to RECIST 1.1. Patients alive without progression will be censored at 6 months and at the date of last news.

    Measured: at 6 and 36 months

  5. Quality of life (QoL)

    Quality of life will be studied by using the EORTC QLQ-C30 questionnaire (European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire for Cancer) at 6 months and at the end of study. A 5-point decrease of QLQ-C30 score will be considered as the minimal clinically significant deterioration of QoL.

    Measured: at 6 and 36 months

  6. time to deterioration

    TTD will be defined as the time from inclusion in the study to deterioration of EORTC QLQ-C30 score with a decrease ≥5 points at any time point after the baseline score, at 6 months and at the end of study

    Measured: at 6 and 36 months

  7. PK-PD evaluation

    PK-PD evaluation: based on available PopPK modelisation and PK samples collected at the time of the response evaluation in this study

    Measured: at 36 months

  8. CA19.9 response

    CA19.9 response will be defined as a percentage of patients with a ≥ 50% reduction from baseline CA19.9 level, at 6 and 12 months.

    Measured: at 6 and 12 months

  9. proportion of patients reaching surgery

    Percentage surgical resection with R0/R1 margins at 6 months and at the end of study.

    Measured: at 6 and 36 months

  10. Mechanisms of EMT

    To assess the mechanisms of EMT reversal by comparing different histological markers on pre-therapeutic biopsies with tumor samples obtained during surgical tumor resection. Descriptive study in spatial transcriptomics and immunohistochemistry of the evolution of EMT markers, Netrin-1 expression, and tumor microenvironment by comparing pre-therapeutic biopsies to tumor samples obtained during surgical tumor resection

    Measured: At month 0

Timeline

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

  1. First posted21 Sep 2022
  2. Study start28 Mar 2023
  3. Primary completion9 Dec 2024
  4. Study completion16 Jun 2025

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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Multicentric prospective single arm phase 1b trial.
Masking
None (open label)
Enrolment
43 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05546853
Sponsor's protocol ID
38RC22.0211
Acronym
LAP-NET1
Status last verified
May 2026
First submitted
15 Sep 2022
Last updated
19 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Roth G, Artru P, Bouche O, Williet N, Ghelfi J, Turpin A, Lievre A, Blanc JF, Evrard C, Bachet JB, Parent P, Manceau M, Roustit M, Borowik A, Granger V, Durand A, d'Engremont C, Girard E, Chirica M, Braissand N, Rama N, Modolo E, Hernandez-Vargas H, Georges E, Scoazec JY, Cros J, Hazard S, Ducarouge B, Decaens T, Bernet A, Mehlen P. Netrin1 blockade alleviates resistance to chemotherapy in pancreatic cancer. Nature. 2026 Jun;654(8119):798-805. doi: 10.1038/s41586-026-10436-4. Epub 2026 Apr 22.

    PubMed 42020751

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing NP137, Oxaliplatin and Irinotecan in people with Pancreatic Ductal Adenocarcinoma, run by University Hospital, Grenoble at 9 sites in France.

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 21 inclusion and 17 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: finished, as of the sponsor's last update on 19 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 9 sites in France. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Percentage Proportion of patients experiencing adverse events (time frame: At 6 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 NCT05546853, which also lists 1 linked publication.

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 19 May 2026.

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