A Dose Escalation Study of SHP2 Inhibitor in Patients With Solid Tumors Harboring KRAS of EGFR Mutations...
Non Small Cell Lung CancerColorectal Cancer5 moreA Phase 1 dose escalation study in patients with advanced solid tumors harboring KRAS or EGFR mutations to determine the maximum tolerated dose and recommended Phase II dose of HBI-2376 and characterize its pharmacokinetic profile.
Tislelizumab With Anlotinib and Chemotherapy for Second-line Treatment of Pancreatic Cancer
Pancreatic NeoplasmsThis is a prospective, one-arm, phase II clinical study of Tislelizumab Combined With Anlotinib and Chemotherapy for Second-line Treatment of Advanced or Metastatic Pancreatic Cancer
Phase II Study on Sequential AG and FOLFIRINOX as Neoadjuvant Therapy in Patients With Resectable...
Resectable Pancreatic CancerBased on the safety and benefit of neoadjuvant therapy for patients with pancreatic cancer in the available evidence, as well as the principle of sequential chemotherapy with different regimens and the existing preliminary investigation , the aim of this study was to further explore the efficacy and safety of neoadjuvant therapy with AG regimen followed by FOLFIRINOX regimen in patients with resectable pancreatic cancer, and to assess the impact of neoadjuvant therapy on the health-related quality of life of patients, in order to bring new treatment options for neoadjuvant therapy of pancreatic cancer.
Study of Avutometinib (VS-6766) +Defactinib With Gemcitabine and Nab-paclitaxel in Patients With...
KRAS Activating MutationMetastatic Cancer3 moreThis study will assess the safety and efficacy of avutometinib (VS-6766) and defactinib in combination with gemcitabine and nab-paclitaxel in patients with Pancreatic Ductal Adenocarcinoma (PDAC) who have been previously untreated.
Initial Feasibility Study to Treat Borderline Resectable Pancreatic Cancer With a Planar LDR Source...
Pancreatic CancerInitial study to evaluate local control and the preferred method of attachment of the CivaSheet in the setting of suspected close or positive margins at the time of surgical tumor removal.
CPI-613 (Devimistat) in Combination With Hydroxychloroquine and 5-fluorouracil or Gemcitabine in...
Advanced Biliary Tract CarcinomaAdvanced Colorectal Carcinoma31 moreThis phase II trial tests how well CPI-613 (devimistat) in combination with hydroxychloroquine (HCQ) and 5-fluorouracil (5-FU) or gemcitabine works in patients with solid tumors that may have spread from where they first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that have not responded to chemotherapy medications (chemorefractory). Metabolism is how the cells in the body use molecules (carbohydrates, fats, and proteins) from food to get the energy they need to grow, reproduce and stay healthy. Tumor cells, however, do this process differently as they use more molecules (glucose, a type of carbohydrate) to make the energy they need to grow and spread. CPI-613 works by blocking the creation of the energy that tumor cells need to survive, grow in the body and make more tumor cells. When the energy production they need is blocked, the tumor cells can no longer survive. Hydroxychloroquine is a drug used to treat malaria and rheumatoid arthritis and may also improve the immune system in a way that tumors may be better controlled. Fluorouracil is in a class of medications called antimetabolites. It works by killing fast-growing abnormal cells. Gemcitabine is a chemotherapy drug that blocks the cells from making DNA and may kill tumor cells. CPI-613 (devimistat) in combination with hydroxychloroquine and 5-fluorouracil or gemcitabine may work to better treat advanced solid tumors.
A Study of Docetaxel for Injection (Albumin-bound) in Patients With Pancreatic Cancer
Pancreatic CancerThis trial is a single-arm, multicenter clinical study to evaluate the efficacy and safety of Docetaxel for Injection (Albumin-bound) in patients with pancreatic cancer.
Testing the Addition of Sunitinib Malate to Lutetium Lu 177 Dotatate (Lutathera) in Pancreatic Neuroendocrine...
Metastatic Pancreatic Neuroendocrine TumorPancreatic Neoplasm3 moreThis phase I trial tests the safety, side effects, and best dose of sunitinib malate in combination with lutetium Lu 177 dotatate in treating patients with pancreatic neuroendocrine tumors. Sunitinib malate is in a class of medications called kinase inhibitors and a form of targeted therapy that blocks the action of abnormal proteins called VEGFRs that signal tumor cells to multiply. This helps stop or slow the spread of tumor cells. Radioactive drugs, such as lutetium Lu 177 dotatate, may carry radiation directly to tumor cells and not harm normal cells. It is also a form of targeted therapy because it works by attaching itself to specific molecules (receptors) on the surface of tumor cells, known as somatostatin receptors, so that radiation can be delivered directly to the tumor cells and kill them. Giving sunitinib malate and lutetium Lu 177 dotatate in combination may be safer and more effective in treating pancreatic neuroendocrine tumors than giving either drug alone.
Tg01 Vaccine / Qs-21 Stimulon™ With Or Without Balstilimab As Maintenance Therapy Following Adjuvant...
Pancreas CancerResearchers want to discover if the new drug "TG01" will work with participants' bodies to help their immune system attack any cancer cells that might still be in the blood stream after surgery for pancreatic cancer. The researchers will also investigate whether or not "TG01" combined with the other study drug, "Balstilimab", will show even greater efficacy. TG01 and Balstilimab are both experimental treatments and are not approved by the US Food and Drug Administration (FDA) as treatment in the United States, or elsewhere, for pancreatic cancer or any other type of cancer. Balstilimab has been studied in other cancers and has shown signs of efficacy. Another drug will be used in this study called "QS-21". It is not intended to treat any disease but is used in this study to improve the action of the study drug TG01. QS-21 has been approved by the US Food and Drug Administration (FDA) to be mixed with a vaccine used to prevent shingles. It has not been approved to be mixed with the study drug, TG01. Participants will undergo eligibility screening, weekly visits during treatment when receiving the study drug or study drug combination, two safety follow-up visits, at about 30 and 90 days after the last dose of study treatment, and long term follow up for about 12 months after the last dose of study treatment.
A Trial of Cobicistat and Gemcitabine and Nab-Paclitaxel in Patients With Advanced Stage or Metastatic...
CYP3A InhibitorAdvanced Stage or Metastatic Pancreatic Ductal Adenocarcinoma3 moreTo explore the possibility to overcome CYP3A-mediated resistance to anticancer drugs in pancreatic cancer, we will investigate the pharmacokinetics, safety, tolerability, and efficacy of nanoparticle albumin-bound paclitaxel (nab-paclitaxel) in combination with gemcitabine and the CYP3A inhibitor cobicistat in a phase I proof-of-concept trial to determine the safety profile, the recommended dose of nab-paclitaxel in combination with gemcitabine and cobicistat, and to determine whether there is an early efficacy signal warranting a larger scale trial. The present trial is an open-label trial consisting of a dose-escalation part and an expansion part. The dose escalation part is designed to determine the safety, tolerability, and pharmacokinetics of nab-paclitaxel in combination with gemcitabine and cobicistat and will guide the dosing in the expansion part of the trial. The trial enrolls patients with unresectable locally advanced or metastatic pancreatic adenocarcinoma and adequate performance score (ECOG PS 0-2) who would usually receive gemcitabine and nab-paclitaxel according to standard of care. Primary endpoint for the phase I trial is the safety of the combination. Overall survival (OS), disease control rate (DCR), overall response rate (ORR), duration of response (DoR) and progression free survival (PFS) are secondary efficacy endpoints. Further secondary endpoints are tolerability, pharmacokinetics, pharmacodynamics, and pharmacogenomics.