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Phase II, Neoadjuvant study of parasympathetic stimulation with bethanechol in combination with gemcitabine and nab-paclitaxel in borderline resectable pancreatic adenocarcinoma

Principal Investigator:

Susan E. Bates, MD

Contact Number:

212-342-5162

NCT Number:

NCT05241249

Population:

Adult

Phase:

II

of this study is to determine whether the drug, bethanechol, could potentially be used in combination with chemotherapy regimen gemcitabine and nab-paclitaxel and surgery to decrease the chance of the cancer coming back after it is removed. Animal models have shown that treatment with bethanechol can inhibit cancer growth and spread. The chemotherapy regimen nab-paclitaxel for use in combination with gemcitabine to treat patients with metastatic pancreatic cancer is FDA approved. Although bethanechol is FDA approved, in this study its use is experimental. The aim of the study is to show that...
Phase 1, window of opportunity study of parasympathetic stimulation with bethanechol in localized pancreatic adenocarcinoma prior to surgery.

Principal Investigator:

Susan E. Bates, MD

Contact Number:

212-342-5162

NCT Number:

NCT03572283

Population:

Adult

Phase:

I

1. Are you 18 years of age or greater? 2. Do you have recurrent glioblastoma? 3. Is this the first or second time your glioblastoma reoccurred? 4. Did your first treatment include radiotherapy and temozolomide? Are you Eligible? (Inclusion Criteria) The purpose of this study is to determine whether the drug, bethanechol, could potentially be used in combination with surgery to decrease the chance of the cancer coming back after it is removed. Bethanechol is a medication that regulates the parasympathetic nervous system and is often used to manage the side effects of chemotherapy drugs and to...
Targeted (Intra)arterial Gemcitabine vs. Continuation of IV Gemcitabine plus Nab-Paclitaxel following Induction with Sequential IV Gemcitabine plus Nab-Paclitaxel and Radiotherapy for Unresectable Locally Advanced Pancreatic Cancer (TIGeR-PaC)

Principal Investigator:

Susan E. Bates, MD

Contact Number:

212-342-5162

NCT Number:

NCT03257033

Population:

Adult

Phase:

III

The purpose of this research study is to find out whether using a newer method of targeted local delivery of the chemotherapy directly into an artery close to the pancreas tumor after treatment with standard chemotherapy that is delivered by vein is more effective at preventing the tumor from growing as compared with just receiving standard chemotherapy into a vein that goes throughout the body. This study will compare how IA and IV medication affects the time that patients survive and their quality of life. Are you Eligible? (Inclusion Criteria) Age ≥ 18 years Histologically or...
A Phase 1 Study to Evaluate the Safety and Tolerability of AB680 Combination Therapy in Participants with Gastrointestinal Malignancies

Principal Investigator:

Gulam A. Manji, MD

Contact Number:

212-342-5162

NCT Number:

NCT04104672

Population:

Adult

Phase:

I

This study is being done to see if potential new drugs, AB680 and AB122, can be safely given in combination with chemotherapy to study patients with pancreatic cancer. The standard chemotherapy treatments that will be given in combination with AB680 and AB122 are nab-paclitaxel and gemcitabine. AB680 and AB122 are are not approved by the United States Food and Drug Administration (U.S. FDA). Are you Eligible? (Inclusion Criteria) Are you at least 18 years old? Do you have histologically or cytologically confirmed metastatic pancreatic adenocarcinoma? Are you naïve to any prior treatment...
A Phase 1/1b Study of ASP2138 as Monotherapy and in Combination with Pembrolizumab and mFOLFOX6 or Ramucirumab and Paclitaxel in Participants with Metastatic or Locally Advanced Unresectable Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma and in

Principal Investigator:

Ryan H. Moy, MD, PhD

Contact Number:

212-342-5162

NCT Number:

NCT05365581

Population:

Adult

Phase:

I

The goal of this study is to see if a study drug called ASP2138 is safe and effective for people diagnosed with tumors known to have Claudin (CLDN) 18.2 expression. CLDN is a group of proteins seen in gastric-specific, gastroesophageal junction (GEJ) or pancreatic cancer types. The study will also see how ASP2138 is processed in the blood. Each participant will complete a number of procedures and blood collections in order to find the best dose of ASP2138. When this dosage is identified, it will be used to evaluate if ASP2138 causes tumors to shrink. ASP2138 will be assessed continuously...
A Phase I, open-label, multi-center study to evaluate the safety, tolerability, dosimetry andpreliminary activity of [177Lu]Lu-FF58 in patients with selected advanced solid tumors

Principal Investigator:

Ryan H. Moy, MD, PhD

Contact Number:

212-342-5162

NCT Number:

NCT05977322

Population:

Adult

Phase:

I

The purpose of the study is to test the safety and dosing of the study drug, [ 177Lu]Lu-FF58, a radioligand therapy for patients with various types of cancers. The study will also test the ability to identify tumor lesions using the new imaging agent, [68Ga]Ga-FF58, a radioligand imaging agent, and to see if it is safe. Radioligands are a type of cancer medicine in which a radioactive particle is attached to a compound (FF58 in this study). The compound circulates through the bloodstream, binds to proteins found on tumor lesions, and exposes those tumor lesions to radiation. FF58 can be...
A PHASE II RANDOMIZED, OPEN-LABEL, TRIAL OF NAB-PACLITAXEL + GEMCITABINE WITH OR WITHOUT BOTENSILIMAB (AGEN1181) IN PATIENTS WITH METASTATIC PANCREATIC CANCER WHO HAVE PROGRESSED ON PRIOR 5FU + LEUCOVORIN + IRINOTECAN + OXALIPLATIN (FOLFIRINOX)

Principal Investigator:

Gulam A. Manji, MD

Contact Number:

212-342-5162

NCT Number:

NCT05630183

Population:

Adult

Phase:

II

The purpose of this study is to find out if study drug, botensilimab, when given in combination with chemotherapy consisting of nab-paclitaxel + gemcitabine, can help patients with metastatic pancreatic cancer. Botensilimab has not been approved by US Food and Drug Administration (FDA). Nab-paclitaxel + gemcitabine is an approved chemotherapy combination for pancreatic cancer, but they are not FDA approved to treat pancreatic cancer that has progressed after receiving initial treatment. This trial consists of two parts (Part 1 and Part 2). All visits and procedures are the same in both parts...
A Randomized, Double-Blind, Placebo-Controlled Study of Nab-Paclitaxel and Gemcitabine With Or Without SBP-101 in Subjects Previously Untreated for Metastatic Pancreatic Ductal Adenocarcinoma

Principal Investigator:

Gulam A. Manji, MD

Contact Number:

212-342-5162

NCT Number:

NCT05254171

Population:

Adult

Phase:

II/III

The purpose of this study is to investigate how well SBP-101, the study drug, or a placebo works in combination with nap-paclixatel and gemcitabine to treat adenocarcinoma in study participants who have never received treatment for their cancer.A placebo is an inert substance that does not contain any study drug and has no therapeutic value. Placebos are used in studies to help the study team determine if any progress occurs due to the study treatment or due to another outside factor that is not being studied in this research. Participants will be randomized (randomly assigned by a computer)...
A PHASE II, OPEN-LABEL, MULTICENTER, RANDOMIZED STUDY OF THE EFFICACY AND SAFETY OF ADJUVANT AUTOGENE CEVUMERAN PLUS ATEZOLIZUMAB AND mFOLFIRINOX VERSUS mFOLFIRINOX ALONE IN PATIENTS WITH RESECTED PANCREATIC DUCTAL ADENOCARCINOMA

Principal Investigator:

Gulam A. Manji, MD

Contact Number:

212-342-5162

NCT Number:

NCT05968326

Population:

Adult

Phase:

II

The purpose of this study is to compare the effects, good or bad, of autogene cevumeran plus atezolizumab and mFOLFIRINOX compared with mFOLFIRINOX (standard of care chemotherapy) alone on patients with resected pancreatic ductal adenocarcinoma (PDAC). In this study, the participant will get either the combination of autogene cevumeran plus atezolizumab and mFOLFIRINOX or mFOLFIRINOX alone. Autogene cevumeran is a personalized drug product that will be made specifically for the participant and is designed to activate and train your immune system to find and kill cancer cells. Autogene...
A Phase 2, Open-Label, Multicenter, Randomized Study Evaluating neoadjuvant therapy targeting the Adenosine immunosuppressive pathway in combination with Immune checkpoint blockade and Radiation Therapy in Patients with advanced PANCreatic Ductal

Principal Investigator:

Gulam A. Manji, MD

Contact Number:

212-342-5162

NCT Number:

NCT06048484

Population:

Adult

Phase:

II

The main goal of this study is to find out if treatment with zimberelimab and stereotactic body radiation therapy alone or in combination with quemliclustat, with or without etrumadenant, given before surgery is safe and if it can further increase the immune response against the tumor. Are you Eligible? (Inclusion Criteria) You must have been diagnosed with advanced pancreatic adenocarcinoma. -You must be comfortable receiving study drug through a vein in your arm (intravenously). -You must be willing to undergo surgery.

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