A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of INV-8989 in Patients With Advanced Solid Tumors Harboring KRAS G12D Mutations
NCT07610798 · Advance Solid Tumors, Colon and Rectal Cancer,
Non - Small Cell Lung Cancer NSCLC RecruitingThis is a Phase 1 and Phase 2 study to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of INV-8989 in patients with advanced solid tumors harboring KRAS G12D mutations.
PhasePhase 1 / Phase 2
TypeInterventional
Age18 Years
WhereGuangzhou, Guangdong, China
SponsorShenzhen Ionova Life Sciences Co., Ltd.
▾Tap for detailsClick for full details — eligibility, all locations, contacts VMD-928 Monotherapy and in Combination With Pembrolizumab to Treat TrkA Overexpression Driven Solid Tumors or Lymphoma
NCT03556228 · Head and Neck Carcinoma, Adenoid Cystic Carcinoma,
Lung Cancer RecruitingThis is a multicenter, open-label, Phase 1/2 study of orally administered VMD-928 monotherapy and in combination with pembrolizumab in adult subjects with advanced solid tumors or lymphoma that have progressed or are non responsive to available therapies and for which no standard or available curative therapy exists
PhasePhase 1 / Phase 2
TypeInterventional
Age18 Years – 80 Years
WhereSanta Rosa, California, United States + 14 more
SponsorVM Oncology, LLC
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Phase Ib/II Clinical Study of Regorafenib Combined With Toripalimab and Albumin-bound Paclitaxel for the Third-line Treatment of Advanced Pancreatic Cancer
RecruitingThe purpose of this clinical trial is to explore the efficacy and safety of Regorafenib combined with Toripalimab and Paclitaxel-albumin in patients as the third line treatment for patients with unresectable or metastatic pancreatic cancer.The main question it aims to answer is: Phase Ib: Evaluate the maximum tolerated dose (MTD) of regorafenib and/or phase II clinical recommendations Dose (RP2D). Phase II: Evaluation of the efficacy and safety of Regorafenib Combined with Terriptylimab and Albumin Paclitaxel for Late Third Line Treatment for pancreatic cancer patients. Participants will: Phase Ib: Selected patients will receive treatment with Regorafenib at main dose levels of 40, 80, and 120mg/d (po d1-14 Q3W), Toripalimab(240mg, ivgtt, d1, Q3W), and Paclitaxel-albumi(125mg/m2, ivgtt, d1, 8, Q3W) until disease progression or intolerable toxicity occurs. Phase II: Regorafenib: Based on the results of the completed Phase I study, determine the dosage for Phase II (po d1-14 Q3W). Toripalimab (240mg, ivgtt, d1, Q3W) and Paclitaxel-albumi (125mg/m2, ivgtt, d1, 8, Q3W) until disease progression or intolerable toxicity occurs.
PhasePhase 1 / Phase 2
TypeInterventional
Age18 Years – 80 Years
WhereShenzhen, Guangdong, China
SponsorJunjie Hang
▾Tap for detailsClick for full details — eligibility, all locations, contacts Adjuvant Pancreatic Therapy Guided by MRD
NCT06966440 · Pancreatic Adenocarcinoma Resectable
RecruitingPancreatic adenocarcinoma (PAAD) is a leading cause of cancer-related deaths worldwide. Although surgical resection can be curative, the 5-year overall survival (OS) rate after resection alone is approximately 20%. Adjuvant chemotherapy can improve survival outcomes in patients with resected PAAD. This study will explore the application of ctDNA MRD in guiding adjuvant therapy in these patients. This prospective, randomized, interventional trial will evaluate a ct-DNA MRD-guided adjuvant therapy strategy in PAAD patients who have undergone radical resection at our institution. Prior to adjuvant chemotherapy, patients will be randomized (1:1) to either the experimental arm (Arm A) or the control arm (Arm B). Arm A will receive ct-DNA MRD-guided therapy, while Arm B will receive non-ctDNA-driven standard of care post-operative adjuvant therapy. In Arm A, patients will receive a physician-selected, guideline-recommended adjuvant therapy regimen in 12-week cycles. ctDNA MRD will be assessed before the end of first cycle and at weeks 8 and 11. If two consecutive post-treatment MRD tests are negative, therapy will be "de-escalated" (discontinued) with regular follow-up as determined by the clinician. Otherwise, another treatment cycle will be administered, with the same MRD assessment. Following the second cycle, patients without two negative MRD results (only tested at week 8 and week 11 within each cycle) will "escalate" to a longer duration of chemotherapy (comparing to the 6-month standard of care) at the clinician's discretion. Treatment will continue until disease progression, intolerance, or study termination. Arm B will receive standard post-operative adjuvant therapy for a duration recommended by CSCO guidelines (typically 6 months), followed by regular follow-up every 8 weeks. The primary endpoint is to compare the prognosis, tolerability, and treatment completion rates between the two arms.
PhaseNA
TypeInterventional
Age18 Years – 75 Years
WhereShanghai, China
SponsorRuijin Hospital
▾Tap for detailsClick for full details — eligibility, all locations, contacts Panitumumab-IRDye800 in Patients With Pancreatic Cancer Undergoing Surgery
NCT03384238 · Pancreatic Adenocarcinoma
RecruitingThis phase I/II trial studies the side effects and best dose of panitumumab-IRDye800 and to see how well it works in finding cancer in patients with pancreatic cancer who are undergoing surgery. Panitumumab-IRDye800 is a combination of the antibody drug panitumumab and IRDye800CW, an investigational dye that can be seen using a special camera. Panitumumab-IRDye800 may attach to tumor cells and make them more visible during surgery in patients with pancreatic cancer.
PhasePhase 1 / Phase 2
TypeInterventional
Age19 Years
WherePalo Alto, California, United States
SponsorGeorge Poultsides
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study of NT-175 in Adult Participants With Advanced Malignancies That Are Positive for HLA-A*02:01 and the TP53 R175H Mutation
NCT05877599 ·
Non-small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma, Colorectal Carcinoma
RecruitingPhase I Study of NT-175, an autologous T cell therapy product genetically engineered to express an HLA-A\*02:01-restricted T cell receptor (TCR), targeting TP53 R175H mutant malignancies
PhasePhase 1
TypeInterventional
Age18 Years
WhereGilbert, Arizona, United States + 22 more
SponsorAstraZeneca
▾Tap for detailsClick for full details — eligibility, all locations, contacts Effects of Peptamen 1.6 in Malnourished Patients (or at Risk) With Pancreatic Neoplasia Undergoing Cephalic Pancreaticoduodenectomy (CPD): A Mechanistic Study
NCT06852014 ·
Pancreatic Cancer, Adult, Cephalic Duodenopancreatectomy
RecruitingMalnutrition is a common challenge in patients with pancreatic cancer undergoing cephalic pancreaticoduodenectomy (CPD), impacting postoperative recovery and overall prognosis. Nutritional support plays a crucial role in optimising metabolic, inflammatory, and digestive outcomes. This randomised, double-blind, crossover clinical trial aims to evaluate the effects of Peptamen 1.6, a hydrolysed whey protein-based enteral formula, compared to Resource HP/HC, a high-protein and high-calorie polymeric formula, in malnourished or at-risk patients with pancreatic cancer undergoing PD. The study comprises both in vivo and in vitro analyses. The in vivo component will assess the impact of Peptamen 1.6 on digestive tolerance, amino acid absorption, nutritional status, metabolic profile, inflammatory markers, and gut microbiota composition. The in vitro component will utilise human intestinal organoid models to explore how enteral nutrition formulations influence intestinal permeability and metabolism, with a focus on microbiota interactions. Primary outcomes include improvements in metabolic status, assessed through serum biomarkers (albumin, immune markers, intestinal permeability, and myosin profile), inflammatory status via peripheral blood mononuclear cells (PBMCs), and microbiota shifts in faecal samples. Additionally, adherence to treatment, digestive tolerance, and changes in body composition will be monitored using bioelectrical impedance, dynamometry, and functional mobility tests. By elucidating the mechanisms through which different enteral nutrition strategies influence clinical, physiological, and molecular parameters, this study aims to enhance personalised nutritional interventions for patients with pancreatic cancer. The findings could contribute to optimising nutritional support strategies, ultimately improving patient outcomes following CPD.
PhaseNA
TypeInterventional
Age18 Years
WhereMálaga, Málaga, Spain
SponsorFundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
▾Tap for detailsClick for full details — eligibility, all locations, contacts Testing the Safety and Tolerability of the Anti-cancer Drugs Trastuzumab Deruxtecan and Neratinib for Cancers With Changes in the HER2 Gene
NCT05372614 · Metastatic Malignant Solid Neoplasm, Metastatic Pancreatic Adenocarcinoma,
Stage III Pancreatic Cancer AJCC v8 RecruitingThis phase I trial tests the safety, side effects, and best dose of neratinib in combination with trastuzumab deruxtecan in treating patients with solid tumors that have spread from where it first started (primary site) to other places in the body (metastatic) or that cannot be removed by surgery (unresectable), and have changes in a gene called human epidermal growth factor receptor 2 (HER2). Neratinib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals tumor cells to multiply. This helps slow or stop the spread of tumor cells. Trastuzumab deruxtecan is in a class of medications called antibody-drug conjugates. It is composed of a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug, called deruxtecan. Trastuzumab attaches to HER2 positive tumor cells in a targeted way and delivers deruxtecan to kill them. Adding neratinib to trastuzumab deruxtecan may be able to shrink cancer with a change in the HER2 gene.
PhasePhase 1
TypeInterventional
Age18 Years
WhereDuarte, California, United States + 17 more
SponsorNational Cancer Institute (NCI)
▾Tap for detailsClick for full details — eligibility, all locations, contacts The HistoSonics Edison™ System for Treatment of Pancreatic Adenocarcinoma Using Histotripsy
NCT06282809 · Pancreas Cancer, Adenocarcinoma of the Pancreas,
Pancreatic Cancer RecruitingThe purpose of this trial is to evaluate the safety of the HistoSonics Edison System for the destruction of pancreatic adenocarcinomas using histotripsy.
PhaseNA
TypeInterventional
Age18 Years
WhereBarcelona, Spain
SponsorHistoSonics, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts Study of RAS(ON) Inhibitors in Patients With Gastrointestinal Solid Tumors
NCT06445062 ·
Colorectal Cancer, CRC, Pancreatic Ductal Adenocarcinoma
RecruitingThe purpose of this platform study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of novel RAS(ON) inhibitors combined with Standard(s) of Care (SOC) or with novel agents. The current subprotocols include the following: Subprotocol A: RMC-6236 + 5-fluorouracil-based regimens Subprotocol B: RMC-6236 + cetuximab with or without mFOLFOX6 Subprotocol C: RMC-6236 + gemcitabine + nab-paclitaxel Subprotocol D: RMC-9805 with or without RMC-6236 + 5-fluorouracil-based regimens Subprotocol E: RMC-9805 with or without RMC-6236 + cetuximab with or without mFOLFOX6 Subprotocol F: RMC-9805 with or without RMC-6236 + gemcitabine + nab-paclitaxel
PhasePhase 1 / Phase 2
TypeInterventional
Age18 Years
WhereChandler, Arizona, United States + 31 more
SponsorRevolution Medicines, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts PAncreatic Disease Cohort of TOuLouse
NCT05824403 · Pancreatic Diseases
RecruitingThis study is a prospective cohort dedicated to pancreatic diseases excluding cancer. The aim is to develop positive or differential diagnostic tools between benign potentially malignant or malignant pancreatic pathologies. During this study the investigators collect data and biological samples to support research project.
Phase—
TypeObservational
Age18 Years
WhereToulouse, France
SponsorUniversity Hospital, Toulouse
▾Tap for detailsClick for full details — eligibility, all locations, contacts Prospective Screening for Pancreatic Ductal Adenocarcinoma in High-Risk Individuals
NCT06122896 ·
Pancreatic Cancer, Pancreatic Ductal Adenocarcinoma, PDAC
RecruitingThe 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.
PhaseEARLY_Phase 1
TypeInterventional
Age18 Years
WhereBoston, Massachusetts, United States + 1 more
SponsorDana-Farber Cancer Institute
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study of PF-08046054/SGN-PDL1V in Advanced Solid Tumors
NCT05208762 · Carcinoma, Non-Small-Cell Lung, Squamous Cell Carcinoma of the Head and Neck, Esophageal Squamous Cell Carcinoma
RecruitingThis study will test the safety of a drug called PF-08046054/SGN-PDL1V alone and with pembrolizumab in participants with solid tumors. It will also study the side effects of this drug. A side effect is anything a drug does to your body besides treating your disease. Participants will have solid tumor cancer that has spread through the body (metastatic) or cannot be removed with surgery (unresectable). This study will have five parts. Parts A and B of the study will find out how much PF-08046054/SGN- PDL1V should be given to participants. Part C will use the dose found in Parts A and B to find out how safe PF-08046054/SGN-PDL1V is and if it works to treat solid tumor cancers. In Part D and E, participants will be given PF-08046054/SGN-PDL1V with pembrolizumab to find out how safe this combination is and if it works to treat solid tumor cancers.
PhasePhase 1
TypeInterventional
Age18 Years
WhereBirmingham, Alabama, United States + 61 more
SponsorSeagen, a wholly owned subsidiary of Pfizer
▾Tap for detailsClick for full details — eligibility, all locations, contacts Pilot Comparing ctDNA IDV vs. SPV Sample in Pts Undergoing Biopsies for Hepatobiliary and Pancreatic Cancers
NCT05497531 · Hepatobiliary Cancer,
Pancreatic Cancer, Hepatocellular Carcinoma
RecruitingThis is a prospective pilot protocol investigating whether ctDNA detection be improved by sampling the cancer draining vein versus the standard practice of sampling from a peripheral vein in patients who are undergoing biopsies for hepatobiliary and pancreatic cancers.
PhaseNA
TypeInterventional
Age18 Years
WhereOrange, California, United States
SponsorUniversity of California, Irvine
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Phase 1 Study of XL309 (ISM3091) Alone and in Combination in Participants With Advanced Solid Tumors
NCT05932862 · Advanced Solid Tumor
RecruitingThis is a first-in-human (FIH), multicenter, open-label Phase I study to investigate the safety, tolerability, preliminary antitumor activity, as well as pharmacokinetics (PK) and pharmacodynamics of XL309 (previously ISM3091) administered alone or in combination with olaparib in participants with advanced solid tumors.
PhasePhase 1
TypeInterventional
Age18 Years
WhereFountain Valley, California, United States + 15 more
SponsorExelixis
▾Tap for detailsClick for full details — eligibility, all locations, contacts An Open-label, Multicenter, Phase II Clinical Study to Evaluate HRS-7058 in Patients With Pancreatic Cancer
RecruitingThis is a multicenter, open-label, single-arm, phase II cilinical trial designed to evaluate the efficacy and safety of the KRAS G12C selective inhibitor HRS-7058 in patients with KRAS G12C-mutated advanced pancreatic cancer who had failed 1-2 lines of previous systemic therapy.
PhasePhase 2
TypeInterventional
Age18 Years – 75 Years
WhereNanjing, Jiangsu, China + 1 more
SponsorShandong Suncadia Medicine Co., Ltd.
▾Tap for detailsClick for full details — eligibility, all locations, contacts Bio-Repository of High Risk Cohorts for the Early Detection of Pancreas Cancer
NCT03260842 · Pancreatic Cyst, Pancreas Disease
RecruitingBio-repository to collect bio-specimens from patients with 1) pancreatic cysts and 2) patients at high risk, defined by family history and/or genetic mutations, for pancreatic cancer.
Phase—
TypeObservational
Age18 Years
WhereStanford, California, United States
SponsorStanford University
▾Tap for detailsClick for full details — eligibility, all locations, contacts Biospecimen Collection to Identify Gene Mutations for High Risk Pancreatic Cancer in Pediatric Patients, INSPPIRE 2 Study
NCT06651580 · Chronic Pancreatitis, Exocrine Pancreas Carcinoma, Recurrent Acute Pancreatitis
RecruitingThis clinical trial collects blood, saliva, urine, or stool samples to help identify possible genetic mutations that may increase a person's chance at developing pancreatic cancer. Finding genetic markers among pediatric patients with acute recurrent pancreatitis and chronic pancreatitis may help identify patients who are at risk of pancreatic cancer.
Phase—
TypeObservational
Age17 Years
WhereLos Angeles, California, United States + 25 more
SponsorM.D. Anderson Cancer Center
▾Tap for detailsClick for full details — eligibility, all locations, contacts Efficay of Physical Activity Program in PCOS Females With Fatty Pancrease and Thyroid Hypofunction
NCT07591246 · Polycystic Ovary Syndrome, Non-Alcoholic Fatty Pancreatic Disease, Subclinical hypothyroïdism
Recruitingfemales of polycystic ovary syndromes may complain fatty pancreaetic disorder and thyroid hypofunctions (subclinical hypothyroidism)
PhaseNA
TypeInterventional
Age20 Years – 40 Years
WhereGiza, Egypt
SponsorCairo University
▾Tap for detailsClick for full details — eligibility, all locations, contacts This is a Phase 1 Trial of ZM008, an Anti-LLT1 Antibody, Used as Single Agent Followed by Combination Treatment With Toripalimab in Patients With Advanced Solid Tumors
NCT06451497 ·
Non Small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma, Pancreas Adenocarcinoma
RecruitingThis is a phase 1 dose escalation trial of ZM008, an anti-LLT1 antibody as a single agent followed by combination with Toripalimab in patients with advanced solid tumors who have exhausted all standard therapy available or are intolerant of the same.
PhasePhase 1
TypeInterventional
Age18 Years
WhereBoston, Massachusetts, United States + 2 more
SponsorZumutor Biologics Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts