Clinical Research Directory

AGEN1423 and Botensilimab w/ or w/o Chemo in PDAC

The goal of this research study is to asses the safety and efficacy of the combination of AGEN1423 and Botensilimab with or without chemotherapies, gemcitabine and nab-paclitaxel, for the treatment of advanced pancreatic ductal adenocarcinoma (PDAC) which has progressed after at least one previous line of cancer therapy. The names of the study drugs involved in this study are: * AGEN1423 * Botensilimab Participants will receive study treatment for about 2 years and will be followed for 1 year after.

Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-M05D1 in Subjects With Solid Tumors

The objective of this study is to evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-M05D1 in Subjects with Advanced or Metastatic Solid Tumors.

A First-in-human Study of BGB-53038, a Pan-KRAS Inhibitor, Alone or in Combinations in Participants With Advanced or Metastatic Solid Tumors With KRAS Mutations or Amplification

This is a first-in-human (FIH), open-label, multicenter, dose escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of BGB-53038 as monotherapy in participants with advanced or metastatic solid tumors harboring KRAS mutations or amplification, as well as when used in combination with tislelizumab (also known as BGB-A317) in participants with nonsquamous non-small cell lung cancer (NSCLC) and used in combination with cetuximab in participants with colorectal cancer (CRC). The study consists of 2 phases: Phase 1a Dose Escalation and Safety Expansion and Phase 1b Dose Expansion.

Nano-Megestrol Acetate for Cancer Cachexia in Advanced Pancreatic Cancer

Cancer anorexia-cachexia syndrome is a common and severe complication in patients with advanced cancer, with a particularly high prevalence in pancreatic cancer. It is associated with systemic inflammation, metabolic disturbances, and dysregulation of central appetite control, leading to reduced quality of life, poor tolerance to anticancer therapy, and shortened survival. Anticancer treatments, including chemotherapy and immunotherapy, may further exacerbate the development and progression of cachexia. Megestrol acetate is recommended as a first-line treatment for cancer-related anorexia-cachexia syndrome by multiple international and national guidelines, based on its proven effects on appetite stimulation, weight gain, and quality of life improvement. The nanocrystalline formulation of megestrol acetate significantly enhances bioavailability and achieves effective plasma concentrations even in the fasting state, making it particularly suitable for patients with cancer cachexia. This randomized, controlled, prospective study aims to evaluate the efficacy and safety of nanocrystalline megestrol acetate in patients with advanced pancreatic cancer complicated by cancer anorexia-cachexia syndrome. The study will assess improvements in appetite, body weight, nutritional status, and quality of life, and explore the clinical value of early anti-cachexia intervention in the era of immuno-chemotherapy, providing evidence to optimize comprehensive treatment strategies for advanced pancreatic cancer.

ATRA and SDK002 in Combination With Chemotherapy and Anti-PD-1 Inhibitor in Patients With Advanced Pancreatic Ductal Adenocarcinoma.

This study is testing whether adding three drugs, All-Trans Retinoic Acid (ATRA), SDK002 (also called Arsenic Trioxide or ATO), and tislelizumab, to standard chemotherapy is safe for people with advanced pancreatic cancer. Advanced pancreatic cancer means the cancer has spread or cannot be removed with surgery. The study will also look at whether this treatment combination may help people live longer. Participants will receive standard chemotherapy drugs, gemcitabine and nab-paclitaxel, together with ATRA, SDK002, and tislelizumab. ATRA is related to vitamin A and may affect how cancer cells grow. SDK002 is a drug used to treat sine cancers and may help other treatments work better. Tislelizumab is an immunotherapy drug, which helps the immune system recognize and attack cancer cells. This is a phase 1 study, which means the main goal is to test safety and side effects. All participants receive the same treatment, and both the study doctors and participants know which drugs are being given.

Study Of Gemcitabine, Nab-paclitaxel, PEGPH20 and Rivaroxaban for Advanced Pancreatic Adenocarcinoma

The purpose of this study is to test any good and bad effects of the study drug called PEGPH20. PEGPH20 alone is considered investigational. The Food and Drug Administration (FDA) has not approved the marketing or sale of PEGPH20, but have authorized its use in research studies with humans. PEGPH20 could shrink the cancer but it also can cause side effects. PEGPH20 is an enzyme that breaks down a specific tissue component called hyaluronan produced by some tumors. Pancreatic tumors often have a large amount of hyaluronan. The removal of hyaluronan from tumors may decrease tumor growth.

Lenvatinib and Pembrolizumab Maintenance Therapy for the Treatment of Patients of Advanced Unresectable Pancreatic Cancer

This phase II trial studies the effects of lenvatinib and pembrolizumab maintenance therapy in treating patients with pancreatic cancer that has spread to other places in the body (advanced) and cannot be removed by surgery (unresectable). Lenvatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving lenvatinib and pembrolizumab may be effective as a maintenance therapy in patients with pancreatic cancer.

Icaritin in Combination With AG in Patients With Previously Untreated Advanced Pancreatic Ductal Adenocarcinoma

Icaritin is a drug that has been approved by the National Medical Products Administration (NMPA) based on a multicenter, randomized, double-blind, parallel-controlled Phase III clinical trial - SNG1705 ICR-1. It is used for patients with unresectable hepatocellular carcinoma who are not suitable for or refuse standard treatment and have not previously received systemic therapy. According to numerous studies, in tumor cells, Icaritin can downregulate the expression of TNF-α, IL-6, PD-L1 and exert anti-tumor effects. At the same time, it regulates the tumor immune microenvironment by reducing the secretion of TNFa and IL-6 as well as inhibiting PD-L1 expression through decreasing MDSC cell proportion. Importantly, Icaritin has excellent safety profile and greatly ensure patients' quality of life clinically. Rare grade 3-4 TRAEs were observed in clinical trials which is uncommon among existing standard drugs. Good safety is a prerequisite for combination therapy; therefore, further exploration of optimal drug combinations is worth considering. Thus,we investigated the efficacy and safety of Icaritin administered in conjunction with AG in patients newly diagnosed with advanced pancreatic ductal adenocarcinoma, compare with AG only.