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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 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, Placebo-Controlled, Double-Blind, Multicenter, Phase 3 Trial of Quemliclustat and Chemotherapy Versus Placebo and Chemotherapy in Patients With Treatment-Naive Metastatic Pancreatic Ductal Adenocarcinoma

Principal Investigator:

Gulam A. Manji, MD

Contact Number:

212-342-5162

NCT Number:

NCT06608927

Population:

Adult

Phase:

III

The purpose of this research is to determine the safety and efficacy of investigational study drug quemliclustat (also known as AB680) in combination with chemotherapy gemcitabine and nab-paclitaxel (Gem-NP), compared to a placebo (saline solution not containing treatment drug) in combination with chemotherapy gemcitabine and nab-paclitaxel at treating participants with the type of cancer you have. Quemliclustat has not been approved by the Food and Drug Administration (FDA). Gemcitabine and nab-paclitaxel (Gem-NP) is FDA approved but not in combination with quemliclustat. This is a double-...
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...
RASolute 302: A Phase 3 Multicenter, Open-label, Randomized Study of RMC-6236 versus Investigator’s Choice of Standard of Care Therapy in Patients with Previously Treated Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)

Principal Investigator:

Gulam A. Manji, MD

Contact Number:

212-342-5162

NCT Number:

NCT06625320

Population:

Adult

Phase:

III

The purpose of this study is to test an experimental drug called RMC-6236. RMC-6236 is an experimental drug, which means that it is not approved by the United States (US) Food and Drug Administration (FDA). RMC-6236 is currently being investigated in other ongoing studies, and this is the first study investigating RMC-6236 in only pancreatic cancer. You will be randomly assigned to receive either RMC-6236 or a chemotherapy regimen chosen by the study doctor (in the form of combinations of approved drugs 5-fluorouracil, leucovorin, oxaliplatin, irinotecan, and liposomal irinotecan or...
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.
Chemo4METPANC - A Phase 2 study with combination Chemotherapy (Gemcitabine and Nab-Paclitaxel), chemokine (C-X-C) motif receptor 4 inhibitor (BL-8040), and immune checkpoint blockade (Cemiplimab) in METastatic treatment naïve PANCreas adenocarcinoma.

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...
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 -...
Phase I trial of ZEN003694 (ZEN-3694) in combination with capecitabine in patients with solid tumors

Principal Investigator:

Ryan H. Moy, MD, PhD

Contact Number:

212-342-5162

NCT Number:

NCT05803382

Population:

Adult

Phase:

I

The purpose of this study is to test the safety of a drug called ZEN003694 (ZEN-3694), in combination with the usual approach of capecitabine. This study tests different doses of ZEN003694 in combination with capecitabine to see which dose is safer for people. There will be between 21 and 30 people taking part in this study. This drug combination is not approved by the FDA for treatment of the disease being studied. Are you Eligible? (Inclusion Criteria) Are you 18 years of age or older? Have you been diagnosed with metastatic or unresectable cancer, which progressed while you were treated...

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