Clinical Studies for Gastrointestinal

Title: A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 193 in Combination With other Therapies in Subjects With Advanced Gastrointestinal, Biliary Tract, or Pancreatic Cancers With Homozygous MTAP-deletion Master Protocol
Brief Title: A Study Evaluating AMG 193 in Combination With Other Therapies in Participants With Advanced Gastrointestinal, Biliary Tract, or Pancreatic Cancers With Homozygous Methylthioadenosine Phosphorylase (MTAP)-Deletion (MTAPESTRY 103)
Brief Summary: The study aims to determine maximum tolerated dose (MTD) or recommended combination dose of the MTA-cooperative PRMT5 inhibitor AMG 193 administered in combination with other therapies in adult participants with metastatic or locally advanced methylthioadenosine phosphorylase (MTAP)-deleted gastrointestinal, biliary tract, or pancreatic cancers. The study also aims to determine the safety profile of AMG 193 administered in combination with other therapies in adult participants with metastatic or locally advanced MTAP-deleted gastrointestinal, biliary tract, or pancreatic cancers.
For info regarding 24-424 please contact Cancer Clinical Trials at 617-975-7403 or cancerclinicaltrialsinfo@bidmc.harvard.edu
 
Title: 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 adenocarcinoma.
Brief Title: Chemo4METPANC Combination Chemokine Inhibitor, Immunotherapy, and Chemotherapy in Pancreatic Adenocarcinoma
Brief Summary: The purpose of this study is to determine if combination treatment with cemiplimab, motixafortide, gemcitabine, and nab-paclitaxel is effective in decreasing the size of the tumor(s), if it will prolong life in patients, and if it's safe. The treatment consists of standard chemotherapy (gemcitabine and nab-paclitaxel) which is FDA approved and is standard treatment for patients with pancreatic adenocarcinoma. Participants will receive immunotherapy (cemiplimab) which activates the body's immune system to attack cancer cells. Cemiplimab is FDA approved for treatment of skin cancer but not for pancreas cancer. Participants will also receive Motixafortide, a new medication which has shown in the laboratory to help immunotherapy work better. Motixafortide has been tested together with immunotherapy (Pembrolizumab), and chemotherapy (5-Fluorouracil and liposomal Irinotecan) and was deemed safe to test additional patients. Motixafortide has not been tested with the specific immunotherapy (Cemiplimab) and chemotherapy (gemcitabine and nab-paclitaxel) which participants will receive and is being tested in this clinical trial.
For info regarding 24-417 please contact Cancer Clinical Trials at 617-975-7403 or cancerclinicaltrialsinfo@bidmc.harvard.edu
 
Title: A PHASE II, OPEN-LABEL, MULTI-COHORT, MULTICENTER STUDY IN PATIENTS WITH UNRESECTABLE HEPATOCELLULAR CARCINOMA AND CHILD-PUGH B7 AND B8 CIRRHOSIS
Brief Title: A Study Evaluating Atezolizumab, With or Without Bevacizumab, in Participants With Unresectable Hepatocellular Carcinoma and Child-Pugh B7 and B8 Cirrhosis
Brief Summary: The purpose of this study is to assess the safety of atezolizumab and bevacizumab, or atezolizumab alone, as first-line treatment in participants with unresectable, locally advanced or metastatic hepatocellular carcinoma (HCC) with Child-Pugh B7 or B8 cirrhosis.
For info regarding 24-268 please contact Cancer Clinical Trials at 617-975-7403 or cancerclinicaltrialsinfo@bidmc.harvard.edu
 
Title: An Open-Label, International, Multicenter, Phase 1b/2a Study to Assess the Safety, Tolerability, and Efficacy of IDX-1197 in Combination with Xelox (Capecitabine and Oxaliplatin) or Irinotecan in Patients with Advanced Gastric Cancer
Brief Title: Study to Assess the Safety, Tolerability, and Efficacy of IDX-1197 in Combination with XELOX or Irinotecan in Patients with Advanced Gastric Cancer
Brief Summary: This is an open-label, Phase 1b/2a study to evaluate the safety and tolerability of IDX-1197 and determine the MTD and RP2D in combination with XELOX or irinotecan in patients with advanced gastric cancer.
For info regarding 23-709 please contact Cancer Clinical Trials at 617-975-7403 or cancerclinicaltrialsinfo@bidmc.harvard.edu
 
Title: A Phase 1 Study of ASP3082 in Participants with Locally Advanced or Metastatic Solid Tumor Malignancies with KRAS G12D Mutation
Brief Title: A Study of ASP3082 in Adults With Advanced Solid Tumors
Brief Summary: This is an open-label study. This means that people in this study and clinic staff will know that they will receive ASP3082. The study aims to check how safe and well-tolerated ASP3082 is for people with advanced solid tumors that have a specific mutation called KRAS G12D. This study will be in 2 parts. In Part 1, different small groups of people will receive lower to higher doses of ASP3082 by itself, or together with cetuximab. Any medical problems will be recorded at each dose. This is done to find suitable doses of ASP3082, by itself or together with cetuximab, to use in Part 2 of the study. The first group will receive the lowest dose of ASP3082. A medical expert panel will check the results from this group and decide if the next group can receive a higher dose of ASP3082. The panel will do this for each group until all groups have received ASP3082 (by itself or together with cetuximab) or until suitable doses have been selected for Part 2. In Part 2, ASP3082 will be given in by itself, or in combination with the other study treatments. Study treatments will be given through a vein. This is called an infusion. Each treatment cycle is 21 or 28 days long. They will continue treatment until: they have medical problems from the treatment they can't tolerate; their cancer gets worse; they start other cancer treatment; or they ask to stop treatment.
For info regarding 22-574 please contact Cancer Clinical Trials at 617-975-7403 or cancerclinicaltrialsinfo@bidmc.harvard.edu
 
Title: A Phase 1 Neoadjuvant Trial of Selective Internal Yttrium-90 Radioembolization (SIRT) with Tremelimumab and Durvalumab (MEDI4736) for Resectable Hepatocellular Carcinoma
Brief Title: SIRT With Tremelimumab and Durvalumab for Resectable HCC
Brief Summary: The goal of this research study is to evaluate the safety and tolerability of tremelimumab and durvalumab with or without Selective Internal Yttrium-90 Radioembolization (SIRT) in participants with resectable hepatocellular carcinoma (HCC) who will undergo liver surgery. The names of the interventions involved in this study are: - Durvalumab (a type of immunotherapy) - Tremelimumab (a type of immunotherapy) - Selective Internal Yttrium-90 Radioembolization (SIRT) (a type of radiation microsphere bead)
For info regarding 22-401 please contact Cancer Clinical Trials at 617-975-7403 or cancerclinicaltrialsinfo@bidmc.harvard.edu
 
Title: A Single Arm Phase 2 Study of Y-90 SIRT in combination with durvalumab (MEDI 4736) and gemcitabine/cisplatin in locally advanced, unresectable or metastatic biliary tract cancer
Brief Title: Y-90 With Durvalumab/Gem/Cis in Intrahepatic Cholangio
Brief Summary: This trial is designed to study a combination of interventions (chemotherapy, immunotherapy, and radiation) as a potential new treatment for bile duct cancer that cannot be removed with surgery. The specific names of the interventions that will be used are: - Y-90 (a type of radiation microsphere bead) - Durvalumab (a type of immunotherapy) - Gemcitabine (a type of chemotherapy) - Cisplatin (a type of chemotherapy)
For info regarding 21-541 please contact Cancer Clinical Trials at 617-975-7403 or cancerclinicaltrialsinfo@bidmc.harvard.edu
 
Title: Phase IB Study of Atezolizumab and Bevacizumab with SBRT for Unresectable Hepatocellular Carcinoma
Brief Title: Atezolizumab+Bevacizumab+SBRT in Unresectable HCC
Brief Summary: This research study is evaluating the safety and tolerability of the drugs atezolizumab and bevacizumab with stereotactic body radiation therapy (SBRT) for treating unresectable hepatocellular carcinoma. This study involves the following interventions: - Atezolizumab - Bevacizumab - Stereotactic body radiation therapy (SBRT)
For info regarding 21-286 please contact Cancer Clinical Trials at 617-975-7403 or cancerclinicaltrialsinfo@bidmc.harvard.edu
 
Title: A prospective and longitudinal study of financial toxicity in patients with advanced pancreatic cancer
Brief Title: Financial toxicity in advanced pancreatic cancer
For info regarding 21-140 please contact Cancer Clinical Trials at 617-975-7403 or cancerclinicaltrialsinfo@bidmc.harvard.edu