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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...
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 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.
A Phase I/IIa Randomized Clinical trial to Evaluate the Efficacy of EGFR-targeted, PNU159682-packaged Nanocells and Glycolipid-Packaged Nanocells in combination withGemcitabine and Nab-paclitaxel in Metastatic Pancreatic Ductal Adenocarcinoma

Principal Investigator:

Linda Y. Wu, MD

Contact Number:

212-342-5162

NCT Number:

NCT07049055

Population:

Adult

Phase:

I/II

The purpose of this study is to test a new experimental treatment for people with pancreatic cancer that has spread (metastatic PDAC). The experimental treatment being evaluated is called EGFR-targeted EnGeneIC Dream Vector™ (EDV™), carrying a drug called PNU-159682, or E-EDV-D682, referred to as the “study drug.” The study drug is investigational and has not been approved by the United States Food and Drug Administration (FDA). The study drug is a type of chemotherapy packaged inside a delivery vehicle (manufactured from a non–disease- causing salmonella...
Chemo4METPANC - A Phase 2 study with combination Chemotherapy (Gemcitabine and Nab-Paclitaxel), chemokine (C-X-C) motif receptor 4 inhibitor (Motixafortide), and immune checkpoint blockade (Cemiplimab) in METastatic treatment naïve PANCreas

Principal Investigator:

Gulam A. Manji, MD

Contact Number:

212-342-5162

NCT Number:

NCT04543071

Population:

Adult

Phase:

II

You are being invited to take part in this research study because you have been diagnosed with pancreas cancer that has spread to other parts of the body. The purpose of this study is to determine if combination treatment with cemiplimab, motixafortide, gemcitabine, and nab-paclitaxel is effective in decreasing tumor size and prolonging life in patients with advanced pancreas cancer. The treatment consists of both immunotherapy (cemiplimab and motixafortide) and chemotherapy (gemcitabine and nab-paclitaxel). Gemcitabine and nab-paclitaxel are approved by the Food and Drug Administration (FDA...
RASolute 304: A Phase 3 Multicenter, Open-label, Randomized,2-Arm Study of Adjuvant Daraxonrasib versus Standard of CareObservation Following Completion of Neoadjuvant and/orAdjuvant Chemotherapy in Patients with Resected PancreaticDuctal Adenocarcinoma

Principal Investigator:

Gulam A. Manji, MD

Contact Number:

212-342-5162

NCT Number:

NCT07252232

Population:

Adult

Phase:

III

The purpose of this study is to test an experimental drug called Daraxonrasib (RMC-6236) compared to standard of care observation after finishinged chemotherapy given either before surgery to shrink the tumor (neoadjuvant chemotherapy) or after surgery to kill remaining cancer cells in patients with resected PDAC. Daraxonsrasib (RMC-6236) is not approved by the United States Food and Drug Administration (FDA). People who usually have this type of cancer typically receive surgery followed by chemotherapy, and then are monitored without additional treatment. This study is different because it...
A Platform Study of RAS(ON) Inhibitors in Patients with Gastrointestinal Solid Tumors

Principal Investigator:

Gulam A. Manji, MD

Contact Number:

212-342-5162

NCT Number:

NCT06445062

Population:

Adult

Phase:

I/II

The purpose of this study is to test the safety of an experimental drug called RMC-6236 in combination with several chemotherapy medicines in patients with gastrointestinal cancers. The study will test the safety of RMC-6236 at different doses in combination with a fixed, standard dose of combination anti-cancer therapy, and how your body processes this combination. RMC-6236 is an investigational (experimental) drug, which means that it has not been approved by the United States (US) Food and Drug Administration (FDA). Are you Eligible? (Inclusion Criteria) Must be 18 years old or older -...
A Multicenter Study Evaluating the Safety, Efficacy, and Pharmacokinetics of IDE892 asMonotherapy and Combination Therapy in Participants With MTAP-Deleted Advanced Solid Tumors

Principal Investigator:

Benjamin Herzberg, MD

Contact Number:

212-342-5162

NCT Number:

NCT07277413

Phase:

I

The purpose of this study is to determine the ideal dose of the study drugs, IDE892 by itself and IDE892 in combination with IDE397, and to find out what effect, good and/or bad, these study drugs may have on your cancer. This will be first human study for IDE892. Both IDE892 and IDE397 has not been approved by the United States (US) Food and Drug Administration (FDA). Are you Eligible? (Inclusion Criteria) Must be 18 years old or older - Must be willing and able to provide blood/tumor tissue samples for biomarker testing - Must be able to swallow and retain the study drug
An Open Label, Phase 1, Treatment Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of IDE397 (MAT2A Inhibitor) In Adult Participants with Advanced Solid Tumors

Principal Investigator:

Benjamin Herzberg, MD

Contact Number:

212-342-5162

NCT Number:

NCT04794699

Population:

Adult

Phase:

I

IDE397 is an investigational drug, which has not been approved by health authorities for the treatment of people with your medical condition. It is currently not “on the market” (available for you to receive a prescription for and/or to buy) in any country. In this study, different dose levels of IDE397 will be tested. About 40 patients are expected to participate at approximately 6-8 study centers within the US. At a minimum, 2 patients will be enrolled in each dose level. There will be about 10 dose levels tested (starting at 5 mg). Every time a dose level is found to be safe, a...

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