Clinical Research Directory

Study of Zoldonrasib + Chemo of Investigator's Choice vs Placebo + Chemo of Investigator's Choice as First-line Treatment in Metastatic KRAS G12D-mutated Pancreatic Adenocarcinoma ( RASolute 305 )

The purpose of this study is to evaluate the efficacy of an investigational RAS(ON) inhibitor administered in combination with chemotherapy compared to placebo in combination with chemotherapy.

SBRT Followed by Ipilimumab N01, Sintilimab, Nab-Paclitaxel and Gemcitabine for Locally Advanced Pancreatic Cancer

This is a Phase II, prospective, single-arm exploratory clinical trial designed to evaluate the efficacy and safety of stereotactic body radiotherapy followed by ipilimumab N01 plus sintilimab in combination with nab-paclitaxel and gemcitabine in patients with locally advanced pancreatic cancer. Eligible patients will receive SBRT followed by sequential systemic therapy. The primary endpoint is progression-free survival, and secondary endpoints include overall survival, disease control rate, duration of response, objective response rate, and safety.

Vascular Resection in Robotic Pancreaticoduodenectomy for Pancreatic Cancer

Data for this propensity score-matched (PSM) comparative study were obtained from a prospectively maintained database comprising 679 cases of robotic pancreaticoduodenectomy (RPD). This study aimed to evaluate the feasibility and justification of vascular resection (VR) in RPD for pancreatic cancer. The primary study endpoint was to compare the surgical outcomes between patients undergoing VR (+) and VR (-) in RPD using PSM to minimize selection bias and allow for balanced comparisons. The secondary study endpoint was to assess the impact of VR on oncological outcomes and overall survival in patients with pancreatic cancer undergoing RPD.

Stereotactic Body Radiotherapy and NALIRIFOX for Locally Advanced Pancreatic Cancer

This prospective, multicenter clinical study evaluates the efficacy and safety of NALIRIFOX in combination with Stereotactic Body Radiation Therapy (SBRT) for patients with locally advanced unresectable pancreatic cancer. The primary endpoint is progression-free survival (PFS), with secondary endpoints including objective response rate (ORR), disease control rate (DCR), overall survival (OS), and safety assessment. The study involves two cohorts: Cohort 1 (early SBRT after 1 cycle of NALIRIFOX) and Cohort 2 (late SBRT after 6-8 cycles of NALIRIFOX). A total of 42 participants are expected to be enrolled, with a follow-up period of at least 24 months. This trial aims to provide a novel therapeutic option for this patient population.

A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors

The purpose of the study is to explore the safety and effects of the study drug (PF-08046876) in people diagnosed with advanced cancer of the bladder, lung, head and neck, esophagus, or pancreas. PF-08046876 is an investigational anticancer therapy called an 'antibody drug conjugate' or 'ADC'. ADCs are anticancer drugs designed to stick to cancer cells and kill them. The study drug will be given to participants through a needle in a vein (intravenous infusion). This study includes multiple parts. In the first part of the study, there will be different groups of people receiving different doses of the study drug. The study may also test different schedules. In the second part of the study, groups of people will receive the study drug in dosing regimens deemed to be safe in Part 1. In the third part of the study, people will receive the study drug together with other anti-cancer medicines.

Platform Study of Neoadjuvant and Adjuvant Immunotherapy for Patients With Resectable Adenocarcinoma of the Pancreas

This platform trial will evaluate various immunotherapy combinations given in the neo-adjuvant and adjuvant setting in patients with surgically resectable pancreatic ductal adenocarcinoma.

Tumor Cell and DNA Detection in the Blood, Urine, and Bone Marrow

Patients with resectable solid primary cancers and even limited number of metastases are potentially curable. However, most patients develop recurrences despite surgery. Also, early detection of lung cancer with low dose CT screening may cure patients at an early stage. Circulating and disseminated tumor cell (CTC/DTC) and circulating cell-free (cf) DNA isolation from the blood, urine and bone marrow will increase understanding of cancer spread and advance knowledge to develop individualized therapies and improve screening.

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.

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).

Trial of First-line Gemcitabine and Nab-paclitaxel With or Without L-glutamine in Advanced Pancreatic Cancer

This is a multi-institution, open-label, two-arm, prospective randomized controlled phase I trial with the purpose to investigate the clinical efficacy of combination gemcitabine, nab-paclitaxel, and L-glutamine compared to gemcitabine and nab-paclitaxel alone in treatment-naïve, unresectable or metastatic pancreatic cancer. This study hypothesizes that combining L-glutamine with gemcitabine and nab-paclitaxel represents a superior therapeutic strategy over gemcitabine and nab-paclitaxel alone in the first-line treatment of advanced PDAC based on the positive results of the phase I GlutaPanc trial that demonstrated the feasibility and preliminary efficacy of combining glutamine supplementation with gemcitabine and nab-paclitaxel in the first-line treatment of advanced PDAC. This study also plans to characterize the safety and secondary endpoints of efficacy (ORR and PFS) of the combination in this cohort. Additionally, the study will characterize the anti-cachexia effects of the study combination compared to control through standard measures such as weight gain, weight stability, and body composition assessments. Lastly, this study will conduct correlative studies on study treatment impact on tumor metabolism, the gut microbiome composition and bacterial metabolism, the plasma and fecal metabolome, and inflammatory signaling, relative to control, to identify potential biomarkers to guide selection of candidates ideal for L-glutamine-based combination therapy.

A Neoadjuvant Study of Tislelizumab and SX-682 for Resectable Pancreas Cancer

The purpose of this study is to evaluate the safety and clinical activity of tislelizumab (an anti-PD-1 antibody) in combination with SX-682 (a CXCR1/2 inhibitor) in subjects with newly diagnosed and surgically resectable pancreatic adenocarcinoma.

Mutant KRAS -Targeted Long Peptide Vaccine for Patients at High Risk of Developing Pancreatic Cancer

This Phase 1 study will evaluate safety and the immune response to pooled mutant-KRAS peptide vaccine with poly-ICLC adjuvant for patients who have been identified to be at risk of developing pancreatic cancer.

A Clinical Trial of KVA12123 [TBS-2025] Treatment Alone and in Combination With Pembrolizumab In Advanced Solid Tumors (VISTA-101)

This clinical trial evaluated the safety and efficacy of KVA12123, subsequently designated TBS-2025, alone or combined with pembrolizumab in patients with advanced solid tumors. The study included dose escalation and planned dose expansion phases. Only the dose escalation phases were conducted. The planned dose expansion phase were not initiated following a business decision to discontinue development in solid tumors. This decision was unrelated to any identified safety concern. The study sought to assess the safety of KVA12123 \[TBS-2025\] given alone or with pembrolizumab and to identify appropriate doses for future clinical trials. Participants in the doses for future clinical trials. Participants in the dose escalation phases visited study sites for treatment and safety assessments. These assessments included blood samples, imaging scans, physical examinations, and heart function tests.

Developing New Educational Materials About Genetic Testing for a Diverse Group of Cancer Patients

Genetic testing is a type of test that detects changes to the genes-the DNA instructions that are passed on from the mother and father. The results of a genetic test can confirm whether the participant has a genetic disorder, which is a disease caused in whole or in part by changes to the genes. Genetic testing can also help determine a person's chance of getting or passing on a genetic disorder. Genetic tests use a sample of blood, hair, skin, or other tissue, and they can look at one gene or multiple genes at the same time. Genetic testing may change the options for treating people with certain types of cancer. For example, some medications are more helpful for the treatment of cancer in people with certain gene changes (mutations). The researchers are doing this study to develop new educational materials about genetic testing for people who speak different languages and have diverse cultural and educational backgrounds. During the study, the staff will interview participants with diverse cultural and educational backgrounds and ask them to review a sample of the educational materials that have been developed so far. Participants will give their opinions on these materials, and the researchers will use participants' feedback to improve the materials.

A Multicenter Study of IBI343 Monotherapy Versus Placebo in Subjects With Previously Treated, Claudin (CLDN) 18.2-positive, Pancreatic Cancer(G-HOPE-002)

This is a study of a Multicenter, Randomized, Double-Blind, Phase III Study of IBI343 Monotherapy Plus Best Supportive Care Versus Placebo Plus Best Supportive Care in Participants with Claudin (CLDN) 18.2-Positive, Locally Advanced Unresectable or Metastatic Pancreatic Cancer Who Received at least 2 Prior Lines of Therapy. The primary objective of this study is to determine Overall Survival (OS) of IBI343 plus best supportive care (BSC) compared with placebo plus BSC.

Clinical Study Evaluating the Effect of Losartan

The pancreas is two organs packaged into one. The islets of Langerhans serve critical endocrine functions, and the exocrine portion is a major source of enzymes that are essential for digestion. Pancreatic cancer (PC) is more commonly referred to as pancreatic infiltrating ductal adenocarcinoma in addition to being the second leading cause of cancer death in the United States, after lung cancer in 2020. Whereas pancreatic cancer is the seventh cause of death from cancer in Asia in 2020. Although it is substantially less common than the other malignancies, pancreatic carcinoma is near the top of the list of killers because it is a highly aggressive carry.

Study of Daraxonrasib and Daraxonrasib + GnP as First-line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma

The purpose of this study is to evaluate the safety and efficacy of an investigational RAS(ON) inhibitor administered as monotherapy or in combination with chemotherapy, compared with standard of care (SOC) chemotherapy alone.

Distance-Based Exercise to Preserve Function and Prevent Disability

This clinical trial studies whether an exercise program can be successfully delivered to patients receiving treatment for cancer through virtual sessions and allow patients to exercise in their own home. Treatments for cancer can cause side effects such as fatigue and loss of strength. These side effects can make it difficult to work, take care of family, and do other things the patient wants to do. Preliminary research shows that exercise can help prevent some of these side effects, but it can be more difficult to start an exercise program when a patient is receiving cancer treatment. The exercise program in this study is delivered through telehealth (TH) video calls. The TH sessions are delivered by trained staff that supervise resistance exercises. The trained staff also provide guidance to the patient on completing unsupervised aerobic sessions on their own. This may be a successful way to deliver an exercise program and make it easier for cancer patients to exercise in their own home during treatment.

Phase 1/2 Study of BHB810 in Advanced Gastric and GEJ Adenocarcinoma

This study is looking at how safe BHB810 is in adults with gastric and gastroesophageal adenocarcinoma (GEJ). The purpose of this study is also to look at: how well the study drug works, how the study drug moves into, through, and out of the body, and how your body reacts to the study drug. Participants will get an IV infusion of BHB810 every 2 weeks while on study treatment.

A Phase II Study of GFH375 Combined With GFS202A or GFH276 Versus GFH375 in Patients With Previously Treated Locally Advanced Unresectable or Metastatic Pancreatic Cancer Harboring KRAS G12D Mutation

This is a phase 2 study. All subjects are patients with locally advanced unresectable or metastatic pancreatic cancer harboring KRAS G12D mutation who have received at least one prior line of systemic therapy. The purpose of this study is to evaluate the anti-tumor efficacy of GFH375 plus GFH276 versus GFH375 monotherapy, and to assess the impact of GFH375 plus GFS202A versus GFH375 monotherapy on patient body weight.

A Study of LY4052031 in Participants With Advanced or Metastatic Urothelial Cancer or Other Solid Tumors

The purpose of this study is to find out whether the study drug, LY4052031, is safe, tolerable and effective in participants with advanced, or metastatic solid tumors including urothelial cancer. The study is conducted in two parts - phase Ia (dose-escalation, dose-optimization) and phase Ib (dose-expansion). The study will last up to approximately 4 years.

Tissue Adhesive Glue Modified Cyanoacrylate (Glubran® 2) in Soft Pancreas

This is a single-center, randomized controlled trial comparing the efficacy of pancreaticojejunostomy with modified N-butyl-2-cyanoacrylate(Glubran® 2) versus standard pancreaticojejunostomy without cyanoacrylate in preventing postoperative pancreatic fistula (POPF) in patients undergoing pancreaticoduodenectomy with soft pancreatic texture. The primary endpoint is the incidence of postoperative pancreatic fistula at 30 days post-surgery, as defined by the International Study Group on Pancreatic Fistula (ISGPF) criteria.Secondary outcomes include surgical complications and length of hospital stay. The study will enroll approximately 194 patients at a single center.

Safety and Pharmacokinetics of SM04755 in Subjects With Advanced Colorectal, Gastric, Hepatic, or Pancreatic Cancer

This is an open-label, multi-center, dose escalation study in adult subjects with advanced colorectal, gastric, hepatic or pancreatic cancer. The study will evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of SM04755 administered orally. Upon determination of the maximum tolerated dose (MTD), expansion cohorts may be enrolled.

A Trial to Evaluate Safety and Tolerability of TST001 in Advanced or Metastatic Solid Tumors

This is an open label Phase I/IIa, First in Human trial of TST001, a recombinant humanized anti-Claudin 18.2 (CLDN18.2) IgG1 monoclonal antibody as monotherapy or in combination with nivolumab or standard of care. It is being tested against advanced and/or metastatic solid tumors including gastric, gastroesophageal junction, pancreatic cancers.