Clinical Research Directory

Prospective Screening for Pancreatic Ductal Adenocarcinoma in High-Risk Individuals

The purpose of this research is to see if adding blood-based tests and symptom review to standard-of-care pancreatic cancer screening procedures can identify cancer early among individuals with increased risk.

WASH Trial: Intraoperative Lavage as a Treatment for Pancreatic Cancer

The goal of this clinical trial is to learn if a special washing treatment used during surgery can help people with pancreatic cancer live longer. The study includes adults who are having surgery for suspected pancreatic cancer or related cancers in nearby organs (called periampullary cancers). The main questions it aims to answer are: * Does the washing treatment improve overall survival (how long patients live)? * Does it improve how long patients remain cancer-free and reduce cancer recurrence or complications? The investigators will compare two types of washing treatments and standard care to see if either method improves outcomes. Participants will: Be assigned by chance (randomized) before surgery to one of three groups: * Washing with warm saltwater (saline) * Washing with sterile water * No extensive washing (standard care) Undergo their planned cancer surgery, during which the washing treatment (if assigned) will be performed right after the tumor is removed Be followed over time to monitor survival, cancer recurrence, and any side effects The investigators estimate the washing treatment could increase average survival from about 18 months to 27 months. To ensure enough patients with confirmed pancreatic cancer are included, about 845 participants will be enrolled over time.

A Study to Determine the Effect of CT3001 in Patients With Advanced Solid Tumors

This is an FIH, multicenter, open-label, dose escalation and dose expansion/dose optimization study of CT3001, which will be conducted in 2 phases: Phase 1 and Phase 2b. Phase 1 will be a standard 3+3 dose escalation and dose finding study in patients with advanced solid tumors for whom there is no available therapy (or patients are not candidates for such therapy) for the assessment of DLTs at up to 7 dose levels of CT3001. Phase 2b is a dose finding/dose optimization study of CT3001 in combination with SOC chemotherapy (FOLFOX) to evaluate the safety and preliminary efficacy of CT3001 in patients with advanced CRC who are eligible for re-engaging FOLFOX-based chemotherapy.

A Study of ASP2138 Given Before Surgery, Then Chemotherapy After Surgery, in People With Pancreatic Ductal Cancer

Some people with pancreatic ductal cancer (PDAC) have a protein called Claudin 18.2 (CLDN18.2) in their tumor. ASP2138 is thought to work by binding to CLDN18.2 and a protein on a type of immune cell called a T-cell. The T-cell "tells" the immune system to attack the tumor. This study is for people with resectable PDAC. Resectable means that the tumor can be removed by surgery. In this study, adults with resectable PDAC will receive an ASP2138 injection just below the skin (subcutaneous) 2 weeks before surgery. After surgery, they will be given standard chemotherapy treatments chosen by their study doctor. These include mFOLFIRINOX, gemcitabine with nab-paclitaxel, or gemcitabine with capecitabine. People will receive chemotherapy treatment for up to 6 months, or until their cancer gets worse, they cannot tolerate the chemotherapy, or they or their study doctor thinks they should stop chemotherapy. People will have a final clinic visit about a month after finishing chemotherapy for health checks.

Phase 1 Study to Investigate TCRTs KRAS Mutation in Unresectable, Advanced, and/or Metastatic Solid Tumors

Phase I Study, a master protocol to investigate TCR-Engineered T cells recognizing KRAS mutations in adult subjects with Unresectable, Advanced, and/or Metastatic Solid Tumors.

A Phase 1, Dose-escalation Study of [225Ac]-FPI-2068 in Adult Patients With Advanced Solid Tumours

This is a first-in-human, Phase 1, non-randomized, multicenter, open-label clinical study designed to investigate the safety, tolerability, dosimetry, biodistribution, and pharmacokinetics (PK) of \[225Ac\]-FPI-2068, \[111In\]-FPI-2107, and FPI-2053 in metastatic and/or recurrent solid tumors (HNSCC, NSCLC, mCRC, PDAC, GC, RCC).

A Study of the Pan-KRAS Inhibitor LY4066434 in Participants With KRAS Mutant Solid Tumors

The main purpose of the study is to assess whether the study drug, LY4066434, is safe and tolerable when administered to participants with locally advanced or metastatic solid tumors with certain KRAS mutations. LY4066434 will be given alone or in combination with other treatments. The study will have 2 parts: monotherapy dose escalation and dose optimization. The study is expected to last up to approximately 5 years.

PHL Treatment in Pancreatic Cancer

This proposal will investigate the effect of paricalcitol, hydroxychloroquine, and losartan (PHL) combination of 3 stroma-modifying drugs on pancreatic adenocarcinoma and its stroma.

Fecal Microbial Transplants for the Treatment of Pancreatic Cancer

This early phase I trial examines the safety and effects of fecal microbial transplants in treating patients with pancreatic cancer. scheduled for surgery to remove tumors. Fecal microbial transplant contains the normal microbes found in fecal (stool) material. Giving fecal microbial transplant may help control the disease.

PTM-101 in Pancreatic Ductal Adenocarcinoma (PDAC)

This is a multi-center, non-randomized, single-arm, open-label, phase Ib, dose escalation/dose expansion study of PTM-101 when combined with neoadjuvant chemotherapy for the treatment of treatment-naïve subjects with borderline resectable and locally advanced pancreatic ductal adenocarcinoma (PDAC).

Study for AZD4360 in Participants With Advanced Solid Tumours

The purpose of this study is to evaluate the safety, tolerability, PK, immunogenicity, pharmacodynamics, and preliminary efficacy of AZD4360 in adult participants with locally advanced or metastatic solid tumours selected for expression of CLDN18.2.

iExosomes in Treating Participants With Metastatic Pancreas Cancer With KrasG12D Mutation

This phase I trial studies the best dose and side effects of mesenchymal stromal cells-derived exosomes with KrasG12D siRNA (iExosomes) in treating participants with pancreatic cancer with KrasG12D mutation that has spread to other places in the body. iExosomes may work better at treating pancreatic cancer.

A Study to Assess IPN01194 When Administered Alone in Adults With Advanced Solid Tumours

The purpose of this study is to determine the appropriate dosage, safety and effectiveness of the study drug, IPN01194 in adults with advanced solid tumours. The participants in this study will have advanced solid tumours. 'Advanced solid tumours' refers to cancers that can occur in several places, including cancers in organs or tissues that have spread from their original site to nearby tissues or other parts of the body. In this study, all participants will receive the study drug, which will be taken by mouth (orally).

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

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.

18F-Fibroblast Activation Protein Inhibitor ([18F]FAPI-74) PET Imaging for Cancer Detection

Background: Fibroblast-activation protein (FAP) is an enzyme that appears in high numbers in cancer-associated fibroblasts of certain cancer types. \[18F\]FAPI-74 is a new PET (positron emission tomography) tracer, a substance that is injected into a person s body before an imaging scan. Researchers believe that \[18F\]FAPI-74 PET imaging may be able to visualize cancer more effectively than the approved tracers. If so, the new tracer would make it easier to find FAP-positive tumors in the body. Objective: To see if \[18F\]FAPI-74 PET scan is as good or better than other imaging methods for detecting certain cancers. Eligibility: People aged 18 years or older with one of these cancer types: pancreatic ductal adenocarcinoma (PDAC), cholangiocarcinoma, hepatocellular carcinoma (HCC), gastric cancer, bladder cancer, ovarian cancer, pheochromocytoma/paraganglioma (PPGL), small cell lung cancer (SCLC) or extrapulmonary neuroendocrine cancer (EP-NEC), mesothelioma or sarcoma. Participants must be scheduled or intended to receive treatment for cancer. Design: Participants will have 2 baseline scans: an \[18F\]FAPI-74, and the approved tracer \[18F\]-FDG. The \[18F\]FAPI-74 will be infused through a needle inserted into a vein. About 1 hour later, the participant will undergo imaging. Within 1 week, participants will undergo the same scanning procedures with the approved tracer. If the baseline scan with \[18F\]FAPI-74 shows the tumor(s), scans with this tracer will be repeated when their regular treatment regimen calls for scans again. If the scan with the regular FDG also show tumors, this scan will be repeated within the same week as the repeated \[18F\]FAPI-74 scan. If \[18F\]-FAPi PET scan shows no tumor(s), scans will not be repeated. If the participant's cancer progresses within 2 years, scans may be repeated. Follow-up calls will continue for 2 years.

A Study of ELI-002 7P in Subjects With KRAS/NRAS Mutated Solid Tumors

This is a Phase 1/2 study to assess the safety and efficacy of ELI-002 7P immunotherapy (a lipid-conjugated immune-stimulatory oligonucleotide \[Amph-CpG-7909\] plus a mixture of lipid-conjugated peptide-based antigens \[Amph-Peptides 7P\]) as adjuvant treatment in subjects with solid tumors with mutated KRAS/NRAS. This study builds on the experience obtained with related product ELI-002 2P, which was studied in protocol ELI-002-001 under IND 26909.

Dose Escalation/Expansion Study of Mavrostobart (PT199), an Anti-CD73 mAb, Administered Alone and in Combination With a PD-1 Inhibitor or Chemotherapy (the MORNINGSTAR Study)

This is a first-in-human, Phase 1/2, open-label, study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of Mavrostobart (PT199) alone and in combination with a PD-1 inhibitor or chemotherapy.

A Study to Find a Suitable Dose of ASP5834 in Adults With Solid Tumors

Genes contain genetic code which tell the body which proteins to make. Many types of cancer are caused by changes, or mutations, in a gene called KRAS. Researchers are looking for ways to stop the actions of abnormal proteins made from the mutated KRAS gene. ASP5834 is being studied in people with solid tumors who have certain KRAS gene mutations. Some people with solid tumors of the colon or rectum (colorectal cancer), will be given ASP5834 with panitumumab. Panitumumab is a treatment for colorectal cancer. In this study, the researchers will learn how ASP5834 is processed by and acts upon the body. This information will help find a suitable dose of ASP5834 and check for any potential medical problems from the treatment. The main aims of this study are to check the safety of ASP5834 given by itself or given with panitumumab, and how well it is tolerated; and to find a suitable dose of ASP5834 given by itself or given with panitumumab. People in this study will be adults with locally advanced, unresectable, or metastatic solid tumors with certain KRAS gene mutations. Locally advanced means the cancer has spread to nearby tissue. Unresectable means the cancer cannot be removed by surgery. Metastatic means the cancer has spread to other parts of the body. They either haven't responded to standard treatment or couldn't be given standard treatment. The key reasons people cannot take part are if they have specific uncontrollable cancers such as symptomatic or untreated cancers in nervous system, have specific heart conditions, swelling and irritation of lung tissues (pneumonitis or interstitial lung disease, also called ILD), infections, or have recently had a stroke or a bleed on the brain. In this study, ASP5834 is being given to humans for the first time. This is an open-label study. This means that people in this study and clinic staff will know that they will receive ASP5834 by itself or ASP5834 with panitumumab. This study will be in 2 parts: Part 1 is called Dose Escalation. Different small groups of people will receive lower to higher doses of either: ASP5834 by itself or ASP5834 with panitumumab. Only people who have colorectal cancer will receive ASP5834 with panitumumab. People with any type of solid tumor will receive ASP5834 by itself. For each dose, all medical problems will be recorded. A medical expert panel will check the results and decide if the next group can receive a higher dose of ASP5834. The panel will do this until the planned maximum number of people are treated or until suitable doses have been selected for Part 2. Part 2 is called Dose Expansion. Other different small groups of people will receive ASP5834 or ASP5834 with panitumumab. They will receive the most suitable doses worked out from Part 1. In both parts of the study, the study treatments ASP5834 and panitumumab will be given through a vein. This is called an infusion. Each study treatment cycle is either 21 days or 28 days long. People will continue study treatment until: they have medical problems from the study treatment they can't tolerate; their cancer gets worse; they start other cancer treatment; or they ask to stop study treatment. People will visit the clinic on certain days during their study treatment, with extra visits during the first 2 cycles of study treatment. The study doctors will check for any medical problems from ASP5834. Also, people in the study will have a health check. On some visits they will also have scans to check for any changes in their cancer. Tumor samples will be taken at certain visits during study treatment with the option of a tumor sample being taken if people's cancer gets worse or the cancer comes back. People will visit the clinic shortly after stopping treatment for a health check. After this, people will have health checks every couple of months to check the condition of their cancer. The number of visits and checks done will depend on the health of each person and whether they completed their study treatment or not. It is expected that people will be in this study for about 1 year.

Perioperative or Adjuvant mFOLFIRINOX for Resectable Pancreatic Cancer

The PREOPANC-3 study is a randomized, multicenter, phase 3 trial. Patients with resectable pancreatic cancer will be randomly assigned (1:1) to 8 cycles of neoadjuvant mFOLFIRINOX followed by surgery and 4 cycles of adjuvant mFOLFIRINOX (arm 1) or to upfront surgery followed by 12 cycles of adjuvant mFOLFIRINOX (arm 2). The primary objective of the trial is to determine whether perioperative mFOLFIRINOX improves overall survival compared with adjuvant mFOLFIRINOX in patients with resectable pancreatic cancer.

Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma

The purpose of this study is to evaluate the safety and efficacy of atebimetinib in combination with modified GnP compared with SOC GnP alone.

Dose Escalation and Dose Expansion Study of RMC-6291 Monotherapy in Subjects With Advanced KRASG12C Mutant Solid Tumors

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of escalating doses of RMC-6291 (KRAS G12C(ON) inhibitor) monotherapy in adult subjects with advanced solid tumors and to identify the maximum tolerated dose (MTD), and the recommended Phase 2 dose.

Anti-CD38 Antibody With KRAS Vaccine and Anti-PD-1 Antibody in Subjects With Pancreatic Ductal Adenocarcinoma and Refractory Non-Small Cell Lung Cancer

The goal of this clinical trial is to test the safety and tolerability of anti-CD38 monoclonal antibody (mAb), daratumumab, in combination with KRAS vaccine (Targovax TG-01/Stimulon QS-21) when given with anti-PD-1 (programmed cell death protein 1) mAb (nivolumab) in patients with advanced non-small cell lung cancer (NSCLC) or pancreatic ductal adenocarcinoma (PDAC). The main questions it aims to answer are: * How well does daratumumab and nivolumab, when given with a vaccine, control or stop these types of cancer? * How well does participants bodies handle these study drugs? * Does this combination of study drugs help participants live longer? Participants will receive daratumumab, nivolumab with KRAS vaccine and have regular tests and procedures to follow how the participants are doing on these study drugs.

Study to Evaluate the Diagnostic Performance of GEH300079 (68Ga) Injection PET/CT for Detection of PC in Patients With Colorectal, Gastric, Ovarian, or Pancreatic Cancers (PERISCOPE)

This study is a Phase 2/3, prospective, multicenter, open-label, non-randomized clinical trial, in which GEH300079 (68Ga) PET/CT images will be acquired in patients with primary colorectal, gastric, ovarian, or Pancreatic Ductal Adenocarcinoma (PDAC) cancers and known or suspected Peritoneal Carcinomatosis (PC) before or after institutional Standard of Care (SoC) imaging. The primary objective is to evaluate the diagnostic performance of GEH300079 (68Ga) PET/CT for the detection of PC in patients with colorectal, gastric, or ovarian primary cancers, using a composite standard of truth (SoT), in a region-based analysis. The detection of PC in patients with primary PDAC will be explored in the Phase 2 part of the study. The study is comprised of 2 distinct parts: Phase 2 aims to confirm the statistical and scientific assumptions for the Phase 3 part, and to confirm the optimal dose and timing of acquisition of GEH300079 (68Ga) PET/CT in the PC indication. Phase 2 includes 2 cohorts: Cohort A (participants with colorectal, ovarian and gastric primary cancer), and Cohort B (participants with primary PDAC), where analysis of Cohort B is descriptive only. Phase 3 aims to demonstrate the safety and efficacy of GEH300079 (68Ga) PET/CT for the detection of PC in patients with confirmed colorectal, gastric or ovarian primary cancers.

Safety of RAD301 in Healthy Human Volunteers and Patients With Pancreatic Cancer or Other Solid Tumors

This is a Phase 1a, open label, single dose, extended study of safety and biokinetics of RAD301 in healthy human volunteers and individuals with PDAC or Other Solid Tumors