Ongoing Clinical Trials for Ductal Adenocarcinoma of Pancreas
There are currently 7 ongoing clinical trials investigating new treatments for ductal adenocarcinoma of pancreas. These studies are exploring various chemotherapy combinations, immunotherapy approaches, and targeted treatments across multiple European countries including Belgium, Italy, France, Spain, Austria, and Germany. The trials involve patients at different disease stages, from early-stage resectable disease to advanced metastatic cancer.
Clinical trial locations
- Austria
- Belgium
- Study of SBP-101, Nab-Paclitaxel, and Gemcitabine for Patients with Metastatic Pancreatic Cancer
- Study of fluorouracil, irinotecan and oxaliplatin combination therapy for patients with metastatic pancreatic ductal adenocarcinoma who progressed after gemcitabine treatment
- Study on the Safety and Effects of [68Ga]Ga-DPI-4452 and [177Lu]Lu-DPI-4452 in Patients with Advanced or Metastatic Solid Tumors
- France
- Study of SBP-101, Nab-Paclitaxel, and Gemcitabine for Patients with Metastatic Pancreatic Cancer
- Study on Maintenance Therapy with OSE2101 and FOLFIRI for Patients with Advanced Pancreatic Cancer After Initial FOLFIRINOX Treatment
- Study on the Safety and Effects of [68Ga]Ga-DPI-4452 and [177Lu]Lu-DPI-4452 in Patients with Advanced or Metastatic Solid Tumors
- Germany
- Italy
- Study Comparing Short-Course and Long-Course Chemotherapy with mFOLFIRINOX or PAXG for Patients with Stage I-III Pancreatic Cancer
- Study of RR001 with Gemcitabine and Paclitaxel for Patients with Locally Advanced Pancreatic Cancer
- Study of SBP-101, Nab-Paclitaxel, and Gemcitabine for Patients with Metastatic Pancreatic Cancer
- Study on the Safety and Effectiveness of MK-2870 Alone or with Other Drugs for Patients with Colorectal, Pancreatic, and Biliary Tract Cancers
- Spain
Study of fluorouracil, irinotecan and oxaliplatin combination therapy for patients with metastatic pancreatic ductal adenocarcinoma who progressed after gemcitabine treatment
This trial is evaluating two different chemotherapy combinations for patients whose metastatic disease has progressed after previous treatment with gemcitabine, either alone or combined with Abraxane.
Main inclusion criteria: Participants must be at least 18 years old with confirmed metastatic disease that has progressed after initial gemcitabine-based treatment. They must have good performance status (able to perform daily activities with minimal assistance), measurable disease on imaging tests, and adequate organ function including kidney, liver, and blood counts. A life expectancy of at least 12 weeks is required.
Main exclusion criteria: Patients cannot participate if they have had any other cancer within the past 3 years (except certain skin cancers), have brain metastases, underwent major surgery within 4 weeks, have severe heart conditions including recent heart attack or unstable angina, active uncontrolled infections, or are pregnant or breastfeeding. Known allergies to similar medications also exclude participation.
Focus of the trial: The study aims to determine which of two treatment combinations is more effective for maintaining disease control. One group receives fluorouracil combined with Naliri (liposomal irinotecan), while the other group receives fluorouracil, Naliri, and oxaliplatin. The main goal is to measure how many patients have their cancer remain stable or improve after about 3 months of treatment.
Investigational drugs: The trial uses fluorouracil (5-FU), a standard chemotherapy drug, in combination with Naliri and optionally with oxaliplatin. These medications are administered through intravenous infusion in cycles over several months, with regular monitoring for effectiveness and side effects.
Study of RR001 with Gemcitabine and Paclitaxel for Patients with Locally Advanced Pancreatic Cancer
This trial is testing a novel gene therapy approach for patients with locally advanced disease that cannot be removed by surgery. The study combines a new treatment called RR001 with standard chemotherapy.
Main inclusion criteria: Patients must have confirmed locally advanced, non-resectable disease with at least one tumor measuring 3.5 cm or smaller that is suitable for ultrasound-guided injection. They must be adults over 18 years old with adequate liver, kidney, and bone marrow function. Participants should have a life expectancy of at least 12 weeks and must not have received previous treatment for this cancer. The tumor must be measurable and there should be no evidence of distant spread.
Main exclusion criteria: Patients with other cancer types, those who have had previous treatments that might interfere with the study, severe or uncontrolled medical conditions, pregnancy or breastfeeding, allergies to study medications, or participation in other clinical trials are excluded.
Focus of the trial: The study evaluates the safety and effectiveness of RR001, a gene therapy product injected directly into the tumor under ultrasound guidance, when used alongside standard chemotherapy with gemcitabine and nab-paclitaxel. The trial includes a dose escalation phase to determine the maximum safe dose of RR001.
Investigational drugs: RR001 is the investigational gene therapy administered directly into tumors. It is combined with gemcitabine and nab-paclitaxel, which are standard chemotherapy medications given intravenously to stop cancer cell growth and division.
Study on the Safety and Effectiveness of MK-2870 Alone or with Other Drugs for Patients with Colorectal, Pancreatic, and Biliary Tract Cancers
This trial studies MK-2870, a humanised monoclonal antibody, both as a standalone treatment and in combination with other anticancer agents for various gastrointestinal cancers including advanced or metastatic disease.
Main inclusion criteria: Patients must have unresectable or metastatic disease, or advanced biliary tract cancer. They must have received one previous treatment line and have recovered from any side effects. Both male and female patients are eligible for this study.
Main exclusion criteria: Specific exclusion criteria focus on ensuring patients have the appropriate cancer type and are not in vulnerable populations unable to provide proper consent.
Focus of the trial: The study evaluates the safety, tolerability, and effectiveness of MK-2870 in shrinking tumors or stopping their growth. Researchers monitor treatment response using standardized criteria and track duration of response, progression-free survival, and overall survival rates.
Investigational drugs: MK-2870 is administered through intravenous infusion, either alone or combined with other anticancer medications. The frequency and dosage are determined based on individual response and tolerance to treatment.
Study on the Safety and Effects of [68Ga]Ga-DPI-4452 and [177Lu]Lu-DPI-4452 in Patients with Advanced or Metastatic Solid Tumors
This three-part trial tests two radiopharmaceutical agents in patients with advanced cancer that cannot be surgically removed. The study includes clear cell renal cell carcinoma, ductal adenocarcinoma, and colorectal cancer.
Main inclusion criteria: For Part A, patients must have confirmed unresectable locally advanced or metastatic disease with measurable tumors and adequate organ function. Performance status must be ECOG 0-2. For Parts B and C, requirements are similar but with stricter performance status (ECOG 0-1) and life expectancy of more than 6 months. Blood counts, liver function, and kidney function must meet specific thresholds.
Main exclusion criteria: Patients with surgically removable tumors, medical conditions other than specified cancer types, those outside the age range, inability to provide informed consent, pregnancy or breastfeeding, allergies to study medications, or participation in other trials are excluded.
Focus of the trial: Part A evaluates imaging characteristics of [68Ga]Ga-DPI-4452 with a single dose. Part B determines the optimal dose of [177Lu]Lu-DPI-4452 for treatment. Part C explores the potential of [177Lu]Lu-DPI-4452 to reduce tumor size and assesses preliminary antitumor activity.
Investigational drugs: [68Ga]Ga-DPI-4452 is used for tumor imaging, while [177Lu]Lu-DPI-4452 is being tested as a therapeutic agent to deliver targeted radiation to cancer cells. Both are administered intravenously.
Study Comparing Short-Course and Long-Course Chemotherapy with mFOLFIRINOX or PAXG for Patients with Stage I-III Pancreatic Cancer
This trial compares two different chemotherapy regimens given before surgery for patients with resectable or borderline resectable stage I-III disease. The study aims to determine which treatment approach leads to better outcomes.
Main inclusion criteria: Patients must have confirmed clinical stage I-III disease that is resectable or borderline resectable. They must be between 18 and 75 years old with a Karnofsky Performance Status greater than 60%. Adequate bone marrow, kidney, and liver function is required. Women must not be pregnant or breastfeeding, and all participants of childbearing potential must use reliable birth control. No previous treatment for the cancer is allowed.
Main exclusion criteria: Patients with cancer types other than ductal adenocarcinoma, those outside the specified age range, or those belonging to vulnerable populations are excluded.
Focus of the trial: The study randomly assigns participants to receive either mFOLFIRINOX or PAXG chemotherapy regimens before surgery. The primary goal is to compare progression-free survival between the two treatment approaches. Secondary outcomes include tumor response rates, surgical removal rates, and overall patient health during and after treatment.
Investigational drugs: mFOLFIRINOX includes oxaliplatin, irinotecan, fluorouracil, and leucovorin administered intravenously in two-week cycles. PAXG combines paclitaxel albumin-bound, gemcitabine, and cisplatin given intravenously, plus oral capecitabine, in three-week cycles.
Study on Maintenance Therapy with OSE2101 and FOLFIRI for Patients with Advanced Pancreatic Cancer After Initial FOLFIRINOX Treatment
This trial evaluates maintenance therapy options for patients with locally advanced or metastatic disease who have completed initial FOLFIRINOX chemotherapy and achieved stable disease or tumor response.
Main inclusion criteria: Patients must have confirmed locally advanced or metastatic disease with stable disease or tumor response after 4 months of FOLFIRINOX treatment. They must be HLA-A2 positive, at least 18 years old, with ECOG performance status 0-1. Adequate organ function including specific liver enzyme, bilirubin, blood protein, and blood cell count levels is required. Life expectancy must be at least 3 months. Tissue samples from previous biopsy must be available or patients must agree to new biopsy.
Main exclusion criteria: Patients who are not HLA-A2 positive, have not completed 4-month FOLFIRINOX induction without disease progression, or are outside the specified age range are excluded.
Focus of the trial: The study compares maintenance therapy with FOLFIRI alone versus FOLFIRI combined with OSE2101 immunotherapy. The primary goal is to assess overall survival at 12 months and progression-free survival while monitoring side effects and quality of life.
Investigational drugs: OSE2101 is an investigational immunotherapy administered by injection that works by stimulating the immune system to recognize and attack cancer cells. It is combined with FOLFIRI, a chemotherapy regimen containing fluorouracil and irinotecan given through infusion.
Study of SBP-101, Nab-Paclitaxel, and Gemcitabine for Patients with Metastatic Pancreatic Cancer
This large multi-country trial tests whether adding SBP-101 to standard chemotherapy can improve survival in patients with metastatic disease who have not received previous treatment for their advanced cancer.
Main inclusion criteria: Patients must have confirmed metastatic disease diagnosed within the last 3 months with no prior treatment for metastatic disease. They must be adults aged 18 or older with adequate bone marrow, liver, kidney, and blood clotting function. Life expectancy must be at least 3 months. Women of childbearing potential must have negative pregnancy tests and use reliable birth control. Heart function tests (QTc interval) must be within normal limits.
Main exclusion criteria: Patients with other types of metastatic cancer, those who received different cancer treatment within 4 weeks, serious heart problems, uncontrolled high blood pressure, severe liver or kidney disease, pregnancy or breastfeeding, active infections requiring treatment, or allergies to study drugs are excluded.
Focus of the trial: The study compares overall survival between patients receiving SBP-101 plus nab-paclitaxel and gemcitabine versus those receiving only nab-paclitaxel and gemcitabine. Participants are randomly assigned to treatment groups in a blinded manner. Secondary outcomes include progression-free survival, tumor response rates, and quality of life assessments.
Investigational drugs: SBP-101 is an investigational small molecule administered by subcutaneous injection that affects cellular metabolism. It is combined with nab-paclitaxel and gemcitabine, both standard chemotherapy drugs given intravenously that work by stopping cancer cell growth and division.
Summary
These seven clinical trials represent diverse approaches to treating ductal adenocarcinoma of pancreas at different disease stages. The studies span six European countries, with Italy hosting the most trials (four), followed by Belgium, France, and Spain (three each), and Austria and Germany (one each).
The trials cover a broad spectrum of disease stages and treatment approaches. For early-stage and locally advanced disease, studies are investigating pre-surgery chemotherapy combinations and novel gene therapy approaches. For advanced and metastatic disease, multiple trials focus on optimizing chemotherapy regimens, exploring immunotherapy options, and testing radiopharmaceutical treatments.
Several standard chemotherapy drugs appear frequently across trials, including gemcitabine, nab-paclitaxel, fluorouracil, irinotecan, and oxaliplatin. These established medications are being combined with investigational treatments such as gene therapies (RR001), immunotherapies (OSE2101, MK-2870), metabolic modulators (SBP-101), and radiopharmaceutical agents.
Most trials require adequate organ function and good performance status for participation. Common exclusion criteria include recent other cancers, severe organ dysfunction, pregnancy, and uncontrolled medical conditions. Several studies specifically target patients whose disease has progressed after standard first-line treatments, addressing an important unmet medical need.
The research reflects the ongoing challenge of treating this aggressive cancer type and the medical community’s commitment to finding more effective therapeutic approaches through innovative treatment combinations and novel mechanisms of action.
