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Ongoing Clinical Trials for Adenocarcinoma of the Pancreas

This article provides information about 24 ongoing clinical trials for adenocarcinoma of the pancreas (also known as: pancreatic adenocarcinoma, pancreatic ductal adenocarcinoma, PDAC). These trials are investigating various treatment approaches including chemotherapy combinations, immunotherapies, targeted therapies, and novel imaging techniques across multiple countries in Europe.

Clinical trial locations

Study Comparing FOLFOX (Oxaliplatin, Fluorouracil, Calcium Folinate) to Gemcitabine for Patients with Metastatic Pancreatic Cancer Not Suitable for FOLFIRINOX

This trial, conducted in France, compares two different treatment approaches for patients with metastatic pancreatic cancer who are not suitable for the more intensive FOLFIRINOX regimen. The study evaluates whether FOLFOX (a combination of oxaliplatin, fluorouracil, and calcium folinate) is more effective than gemcitabine as a first-line treatment.

Main inclusion criteria: Participants must have confirmed pancreatic adenocarcinoma that has spread to other parts of the body and have not received prior treatment for metastatic disease. They must be at least 18 years old with adequate organ function and an ECOG performance status of 0-2.

Main exclusion criteria: The trial excludes patients who have received FOLFIRINOX treatment or are considered fit enough to tolerate FOLFIRINOX, as well as those with known allergies to the study medications.

Trial focus: The main goal is to evaluate overall survival over up to 24 months, comparing FOLFOX to gemcitabine. The study also assesses response rates, duration of disease control, quality of life, and side effects.

Investigational drugs: FOLFOX is a chemotherapy combination that interferes with cancer cell DNA, preventing growth and division. Gemcitabine is a single-agent chemotherapy that works by disrupting the growth of cancer cells, slowing or stopping their spread.

Study of drug combination therapy after surgery in patients with resectable pancreatic ductal adenocarcinoma using lab-grown mini-tumors to guide treatment selection

This German trial uses an innovative approach to personalize treatment after surgery. Researchers grow miniature versions of each patient’s tumor in the laboratory (organoids) and test different chemotherapy combinations to predict which treatment will work best for that individual patient.

Main inclusion criteria: Patients must have pancreatic ductal adenocarcinoma that has been completely removed by surgery, with tumor tissue available for organoid creation. They must have adequate blood counts, kidney function (creatinine clearance of 30 ml/min or higher), and liver function, with an ECOG performance status of 0-1.

Main exclusion criteria: The trial excludes patients with evidence of cancer spread after surgery, those who cannot tolerate chemotherapy, and those with significant cholestasis or severe organ dysfunction.

Trial focus: The study evaluates whether treatment selection based on organoid testing can improve outcomes. It measures the feasibility of creating organoids and testing them within 12 weeks after surgery, as well as disease-free survival when treatment is guided by organoid response.

Investigational drugs: The trial uses various chemotherapy combinations including mFOLFIRINOX (fluorouracil, oxaliplatin, irinotecan, and calcium folinate), gemcitabine, capecitabine, and paclitaxel. The specific combination is chosen based on how the patient’s organoids respond to different treatments in laboratory testing.

Study of DS-3939a for Patients with Advanced or Metastatic Solid Tumors

This multi-country trial (France, Spain, Belgium) evaluates a new experimental medication called DS-3939a in patients with various advanced solid tumors, including pancreatic cancer. The study is divided into two parts: one focusing on safety and tolerability, and another measuring effectiveness.

Main inclusion criteria: Participants must be at least 18 years old with confirmed advanced or metastatic cancer, including pancreatic adenocarcinoma. They must have at least one measurable tumor, a left ventricular ejection fraction of at least 50%, adequate organ function, and an ECOG performance status of 0-1.

Main exclusion criteria: The trial excludes patients outside the specified age range and those from vulnerable populations who may need special protection.

Trial focus: The primary goal is to assess the safety and tolerability of DS-3939a, determine the recommended dose, and evaluate preliminary anti-tumor activity. The study measures objective response rate and monitors for side effects throughout treatment.

Investigational drugs: DS-3939a is an experimental medication delivered through intravenous infusion. It is designed to target specific pathways involved in cancer cell growth and survival, though detailed mechanisms are still under investigation.

Study of IPN01194 for Adults with Advanced Solid Tumors, Including Melanoma, Head and Neck Cancer, Pancreatic Cancer, and Colorectal Cancer

This trial conducted in France and Spain evaluates IPN01194, an oral medication that targets the ERK1/2 pathway, in patients with advanced solid tumors including pancreatic ductal adenocarcinoma. The study uses a two-phase approach to determine safety and effectiveness.

Main inclusion criteria: Participants must be at least 18 years old with confirmed metastatic solid tumors, including pancreatic ductal adenocarcinoma, that have specific MAPK pathway mutations. They must have measurable disease, an ECOG performance status of 0-1, and be willing to provide tumor tissue samples.

Main exclusion criteria: Patients with different cancer types not specified in the study, those unable to follow study procedures, pregnant or breastfeeding women, and those with recent participation in other clinical trials are excluded.

Trial focus: The first phase determines the safest and most effective dose while monitoring for side effects. The second phase evaluates how well the treatment reduces tumor size and progression over up to 32 months.

Investigational drugs: IPN01194 is an investigational ERK1/2 inhibitor taken orally as a hard capsule. It works by targeting the ERK1/2 pathway involved in cancer cell growth and survival, potentially slowing or stopping tumor progression.

Study of RR001 with Gemcitabine and Paclitaxel for Patients with Locally Advanced Pancreatic Cancer

This Italian trial tests a novel gene therapy approach called RR001 in combination with standard chemotherapy for patients with locally advanced pancreatic cancer that cannot be removed by surgery. The treatment involves injecting genetically modified cells directly into the tumor using ultrasound guidance.

Main inclusion criteria: Patients must have confirmed pancreatic ductal adenocarcinoma classified as non-resectable locally advanced disease, with at least one measurable tumor lesion of 3.5 cm or smaller suitable for ultrasound-guided injection. They must have adequate liver, kidney, and bone marrow function, an ECOG performance status of 0-2, and be eligible for standard GEM/Nab-PTX chemotherapy.

Main exclusion criteria: The trial excludes patients with other cancer types, evidence of peritoneal or blood-borne spread, those who have had previous treatments, severe medical conditions, or those unable to follow study procedures.

Trial focus: The study aims to establish the maximum tolerated dose of RR001 when combined with chemotherapy and evaluate safety. It also assesses tumor response, disease control, and quality of life throughout the treatment period.

Investigational drugs: RR001 is an investigational gene therapy administered directly into tumors via ultrasound-guided injection. It is combined with gemcitabine and nab-paclitaxel chemotherapy to potentially enhance treatment effectiveness by targeting cancer cells directly while supporting the effects of chemotherapy.

Study on [18F]FAPI-74 for Better Cancer Imaging in Patients with Esophagogastric and Pancreatic Cancer

This Belgian trial evaluates a new imaging method using [18F]FAPI-74 PET/CT scans to detect cancer-associated fibroblasts in patients with oesophagogastric and pancreatic ductal adenocarcinoma. The goal is to determine if this imaging technique provides better cancer detection than standard methods.

Main inclusion criteria: Participants must be at least 18 years old with a new diagnosis of oesophagogastric or pancreatic ductal adenocarcinoma confirmed by biopsy. For pancreatic cancer, the disease must be classified as cT1-4N0-2M0 (except immediately resectable cases). Patients must have had or be scheduled for a [18F]FDG PET/CT scan or conventional imaging within four weeks.

Main exclusion criteria: The trial excludes patients who have already received cancer treatment, those with serious medical conditions that could interfere with the study, pregnant or breastfeeding women, and those with known allergies to study medications.

Trial focus: The study aims to demonstrate whether [18F]AlF-FAPI-74 PET/CT provides superior detection of lymph node and distant metastases compared to conventional imaging methods. It evaluates the detection ratio and clinical utility of this imaging agent.

Investigational drugs: [18F]AlF-FAPI-74 is a radiotracer administered intravenously for PET/CT imaging. It targets fibroblast activation protein, which is often overexpressed in cancer-associated fibroblasts, allowing for enhanced visualization of tumors.

Study on AZD0901 and Drug Combination for Patients with Advanced Gastric, Gastroesophageal, and Pancreatic Cancers Expressing Claudin 18.2

This trial conducted in Poland and Spain investigates AZD0901, both alone and in combination with other anti-cancer medications, for patients with advanced cancers including pancreatic ductal adenocarcinoma that express the Claudin 18.2 protein.

Main inclusion criteria: Participants must be at least 18 years old with confirmed advanced or metastatic pancreatic ductal adenocarcinoma expressing CLDN18.2. For pancreatic cancer patients, they must not have received any previous treatment for metastatic disease (except certain chemotherapy given before or after surgery if disease progressed at least 6 months after the last dose). They must have at least one measurable tumor, ECOG performance status of 0-1, life expectancy of at least 12 weeks, and adequate organ function.

Main exclusion criteria: The trial excludes patients with cancers not expressing CLDN18.2, those outside the specified age range, patients unable to safely tolerate treatment, and those from vulnerable populations not included in the study design.

Trial focus: The study evaluates the safety and tolerability of AZD0901 and assesses preliminary anti-tumor activity in patients with Claudin 18.2-expressing tumors. It monitors overall survival, progression-free survival, and duration of response.

Investigational drugs: AZD0901 is administered intravenously and is being studied for its potential to treat advanced solid tumors expressing Claudin 18.2. It works by targeting this specific protein on cancer cells, potentially disrupting their growth and survival. The study also includes combinations with other medications such as irinotecan, folinic acid, gemcitabine, and fluorouracil.

Study on Ifinatamab Deruxtecan for Patients with Recurrent or Metastatic Solid Tumors

This large multi-country trial (Ireland, Poland, Belgium, France, Germany, Portugal, Spain, Netherlands, Italy) evaluates Ifinatamab deruxtecan (DS-7300a) for various recurrent or metastatic solid tumors, including pancreatic cancer. The medication is tested both alone and in combination with other treatments.

Main inclusion criteria: Participants must be at least 18 years old with confirmed recurrent or metastatic cancer, including pancreatic ductal adenocarcinoma. They must have at least one measurable lesion, ECOG performance status of 0-1, adequate organ function, and documented disease progression after previous treatments.

Main exclusion criteria: Patients without target lesions as defined by RECIST v1.1, those outside the specified age range, and those from vulnerable populations are excluded.

Trial focus: The study evaluates the safety and effectiveness of Ifinatamab deruxtecan in shrinking tumors and controlling cancer growth. It measures objective response rate, duration of response, and progression-free survival through regular assessments.

Investigational drugs: Ifinatamab deruxtecan is an antibody-drug conjugate administered intravenously. It works by targeting specific proteins on cancer cells and delivering a toxic substance directly to them, helping to kill cancer cells while minimizing damage to normal cells.

Study on PBP1510 and Gemcitabine for Patients with Advanced Pancreatic Cancer After Previous Chemotherapy

This Spanish trial evaluates PBP1510, a humanized immunoglobulin G1 kappa monoclonal antibody, in combination with gemcitabine for patients with advanced or metastatic pancreatic cancer who have progressed after previous chemotherapy.

Main inclusion criteria: Participants must be at least 18 years old (or legal age of majority) with confirmed advanced or metastatic pancreatic cancer that has worsened after one previous chemotherapy treatment (two for Phase 1). They must have measurable disease, ECOG performance status of 0-1, life expectancy of at least 3 months, and adequate organ function. Women of childbearing potential must use effective contraception.

Main exclusion criteria: The trial excludes patients who have not received at least one previous line of chemotherapy, those with other cancer types, vulnerable populations, patients outside the age range, and those with medical conditions making participation unsafe.

Trial focus: Phase 1 evaluates safety and tolerability to determine the best dose. Phase 2a assesses safety and effectiveness at the recommended dose, combined with gemcitabine. The study monitors tumor response, progression-free survival, and overall survival.

Investigational drugs: PBP1510 is administered intravenously and is currently in Phase 1/2a trials. It targets specific molecular pathways involved in cancer cell growth. Gemcitabine is a standard chemotherapy drug used in combination with PBP1510 to potentially provide better outcomes for patients whose cancer has progressed after previous treatments.

Study on Preoperative Treatment with mFOLFIRINOX or Gemcitabine-Paclitaxel for Patients with Borderline Resectable Pancreatic Cancer

This Belgian trial evaluates preoperative (neoadjuvant) treatment approaches for patients with borderline resectable pancreatic adenocarcinoma. It compares standard chemotherapy followed by surgery versus chemotherapy combined with specialized radiation therapy before surgery.

Main inclusion criteria: Patients must have confirmed pancreatic adenocarcinoma classified as borderline resectable (cTNM stage T1-4 N0-2 M0) by a multidisciplinary team. They must be at least 18 years old with ECOG performance status of 0-2 (if status is 2, albumin must be greater than 25 g/l). Adequate blood counts, kidney function, and liver function are required.

Main exclusion criteria: The trial excludes patients with other cancer types, those who received prior treatment for metastatic disease, severe medical conditions, and pregnant or breastfeeding women.

Trial focus: The study evaluates overall survival and successful surgical removal rates. It compares standard chemotherapy (mFOLFIRINOX or Gem-Nab-P) with or without isotoxic high-dose stereotactic body radiation therapy before surgery, followed by additional chemotherapy after surgery.

Investigational drugs: mFOLFIRINOX is a combination chemotherapy that includes fluorouracil, oxaliplatin, irinotecan, and calcium folinate. Gem-Nab-P combines gemcitabine and nab-paclitaxel. These are given before surgery to shrink tumors and after surgery to eliminate remaining cancer cells. Some patients also receive specialized radiation therapy (iHD-SBRT) before surgery.

Summary

The 24 ongoing clinical trials for adenocarcinoma of the pancreas demonstrate a diverse range of therapeutic approaches being investigated across Europe. France leads with the highest number of trial locations (11 trials), followed by Spain (11 trials), Belgium (11 trials), and Italy (6 trials). This geographic distribution reflects strong research activity in Western European countries.

Several notable patterns emerge from these trials. Many studies focus on combination therapies, particularly mFOLFIRINOX, which appears in multiple trials either as a standard treatment or in combination with novel agents. There is significant interest in targeted therapies that address specific genetic mutations, such as KRAS-G12D and CLDN18.2 expression. Immunotherapy approaches, including personalized vaccines and checkpoint inhibitors, represent another major research direction.

Advanced imaging techniques using novel radiotracers like [18F]FAPI-74 and 68Ga-FAPI-46 are being evaluated to improve early detection and staging. Several trials employ innovative precision medicine approaches, such as using laboratory-grown tumor organoids to guide treatment selection after surgery.

The trials address different disease stages, from resectable cancer requiring surgical intervention to advanced metastatic disease. Most studies require patients to have adequate organ function and performance status, typically ECOG 0-2, ensuring participants can tolerate the investigational treatments. Many trials specifically target patients whose disease has progressed after standard therapies, highlighting the urgent need for new treatment options in this challenging disease.

Ongoing Clinical Trials on Adenocarcinoma pancreas

  • A Study of Olaparib Maintenance Treatment for Patients with Metastatic Pancreatic Cancer That Responded to First-Line Chemotherapy

    Recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    Italy

  • A study testing ASP3082 in patients with advanced or spreading non-small cell lung cancer and pancreatic ductal adenocarcinoma

    Recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    France

  • Study of drug combination therapy after surgery in patients with resectable pancreatic ductal adenocarcinoma using lab-grown mini-tumors to guide treatment selection

    Recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    Germany

  • Study of 177Lu-FAP-2286 alone and with drug combinations for patients with advanced solid tumors including non-small cell lung cancer, breast cancer, and pancreatic cancer

    Recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium France Italy Spain

  • Study of AZD4360 safety and effectiveness in adults with advanced solid tumors including gastric, gastroesophageal junction, biliary tract cancer and pancreatic cancer

    Recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    Germany

  • Study on Optimizing NALIRIFOX and 5-FU for Metastatic Pancreatic Cancer in First-Line Treatment and Exploring Ciprofloxacin in Second-Line Therapy

    Recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    France

  • Study on AZD0901 and Drug Combination for Patients with Advanced Gastric, Gastroesophageal, and Pancreatic Cancers Expressing Claudin 18.2

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Poland Spain

  • Study on PBP1510 and Gemcitabine for Patients with Advanced Pancreatic Cancer After Previous Chemotherapy

    Recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    Spain

  • A Study of Saruparib for Patients with Metastatic Pancreatic Cancer with Homologous Repair Deficiency as First Treatment

    Not recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    France

  • Study on the Safety and Effectiveness of AZD0022 Alone and with Other Cancer Drugs for Adults with KRAS-G12D Mutated Tumors in Lung, Colorectal, and Pancreatic Cancer

    Not recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Italy The Netherlands Poland Spain

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