Jason S. Starr, D.O.

The overall objective of this project is to combine robust clinical data (e.g. prior chemotherapy or radiation exposure, cumulative radiotheranostic dose) with geneticclonal abnormalities (blood-based CHIP panel) in studying the predisposing risk factors for developing hematological toxicity including t-MN in radiotheranostic treated solid tumor patients.

The purpose of this study is to find a suitable dose of BI 764532 that people with advanced cancer can tolerate when taken alone. Two different doses of BI 764532 are tested in this study.  

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and preliminary effectiveness of [ 212Pb]VMT-α-NET, an alpha particle radiation delivering agent targeted to somatostatin receptor type 2 (SSTR2).

The main objective of this study is to compare effectiveness of bemarituzumab combined with oxaliplatin and 5-fluorouracil (5-FU) (mFOLFOX6) to placebo plus mFOLFOX6 as assessed by overall survival (OS).

The primary objective of this study is to evaluate the safety and tolerability of bemarituzumab plus mFOLFOX6 and nivolumab to treat previously-untreated advanced gastric and gastroesophageal junction cancer.

This is a multicenter, randomized, open-label, 3-arm Phase 3 study to evaluate encorafenib + cetuximab plus or minus binimetinib versus Investigator's choice of either irinotecan/cetuximab or FOLFIRI/cetuximab, as controls, in patients with BRAFV600E mCRC whose disease has progressed after 1 or 2 prior regimens in the metastatic setting. The study contains a Safety Lead-in Phase in which the safety and tolerability of encorafenib + binimetinib + cetuximab will be assessed prior to the Phase 3 portion of the study.

The purpose of this study is to determine how well nivolumab, with or without ipilimumab, works in treating patients with anal canal cancer that has not responded to previous treatment (refractory) and has spread to other places in the body (metastatic). 

The purpose of this study is to determine the safety and tolerability profile of XmAb18087 in subjects with advanced, well-differentiated neuroendocrine tumors (NET) of pancreatic, gastrointestinal, lung, and undetermined origin, and subjects with advanced gastrointestinal stromal tumors (GIST), and to  identify the maximum tolerated dose (MTD) and/or recommended dose (RD) and schedule of XmAb18087 administered by intravenous (IV) dosing on Days 1, 8, 15, and 22 of each 28-day cycle in subjects with advanced NET and advanced GIST, separately.

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and clinical activity of AB308 in combination with zimberelimab (AB122) in participants with advanced malignancies.

The purpose of this study is to evaluate dose escalation and expansion of MT-5111 (a recombinant fusion protein) in subjects with HER2-positive solid tumors.

The purpose of this study is to establish the safety and dose level of AMXT 1501 dicaprate combined with IV DFMO to treat cancer patients.

The purpose of this study is to evaluate the effectiveness and safety of pemigatinib in participants with previously-treated, locally advanced/metastatic or surgically unresectable solid tumor malignancies harboring activating FGFR mutations or translocations.

The purpose of this study is to assess the effectiveness of 2 different doses of onvansertib in combination with FOLFIRI and bevacizumab for the treatment of confirmed metastatic and/or unresectable CRC in patients with a KRAS or NRAS mutation who have progressed on an oxaliplatin/fluoropyrimidinebased regimen in the first-line setting.

The purpose of this study is to evaluate the safety and to determine the recommended phase 2 dose (RP2D) of Lutetium Lu 177 Dotatate in combination with triapine.

The purpose of this study is to assess the safety, tolerability, movement (pharmcokinetics, "PK"), biological response (pharmacodynamics, "PD"), ability of the drug to provoke an immune response (immunogenicity) and anti-tumor activity of MCLA-128 in patients with solid tumors harboring an NRG1 fusion.

This randomized phase II trial studies how well veliparib works with combination chemotherapy and radiation therapy in treating patients with rectal cancer that has spread from where it started to nearby tissue or lymph nodes (locally advanced). Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as modified (m)FOLFOX6 regimen, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Giving veliparib with combination chemotherapy and radiation therapy may kill more tumor cells and giving it before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

This Phase 2, open-label, parallel, 3-cohort, multicenter study will evaluate the safety and efficacy of various combinations of the anti-T-cell immunoglobulin and ITM domain (TIGIT) monoclonal antibody domvanalimab, the anti-programmed cell death protein 1 (PD-1) monoclonal antibody zimberelimab, and multiagent chemotherapy in the first--line setting, and of various combinations of domvanalimab, zimberelimab, the cluster of differentiation 73 (CD73) inhibitor quemliclustat, and chemotherapy in the second-line (2L) or greater setting in participants with locally advanced unresectable or metastatic gastric, gastroesophageal junction (GEJ), and esophageal adenocarcinoma.

The purpose of this study is to test the safety and tolerability of a drug called BAY 1895344 in combination with irinotecan or topotecan at different doses. 

Irinotecan has already been approved by the FDA to treat pancreatic cancer while topotecan has already been approved by the FDA to treat small cell lung cancer.

Another purpose of the study is to check the level of the study drugs in your blood called pharmacokinetics or PK and to see if there are changes in levels of circulating tumor cells in your blood. To assess what effect the study drugs have on damaging the DNA of your cancer, pharmacodynamic or PD studies will be performed from the on-treatment tumor biopsies for patients in the expansion group.  In addition, another objective of the study is for future biobanking studies related to your tumor and blood samples such as a biomarker study.

The purpose of this study is to determine whether Nivolumab in combination with other therapies is more effective than Nivolumab in combination with Ipilimumab in treating patients/subjects with advanced gastric cancer.

This study aims to assess the efficacy of onvansertib in combination with nanoliposomal irinotecan (nal-IRI), leucovorin, and fluorouracil (5-FU) for treatment of participants with histologically confirmed metastatic pancreatic ductal adenocarcinoma (PDAC).

The purpose of this study is to characterize the safety and tolerability of DKN-01 in combination with tislelizumab ± CAPOX (capecitabine + oxaliplatin) in patients with inoperable, locally advanced or metastatic G/GEJ adenocarcinoma.

Advanced Accelerator Applications is currently pursuing marketing approval for 177Lu-DOTA0-Tyr3-Octreotate (Lutathera). This expanded access therapeutic protocol aims to allow patients suffering from inoperable, somatostatin receptor positive, neuroendocrine tumors, progressive under somatostatin analogue therapy to access the investigational product, 177Lu-DOTA0-Tyr3-Octreotate (Lutathera), prior to its commercial availability.

The purpose of this study is to compare the effectiveness and safety of CAM2029 to octreotide LAR or lanreotide ATG in patients with advanced, well-differentiated Gastroenteropancreatic-Neuroendocrine Tumors (GEP-NET). Patients who experience progressive disease in the randomized part of the study may proceed to an open-label extension part with intensified treatment with CAM2029.

The purpose of this study is to evaluate the effectiveness and safety of Folfirinox (FFX) versus CPI-613 + Modified Folfirinox (mFFX) in patients with metastatic adenocarcinoma of the pancreas.

The purpose of this study is to determine the safety and preliminary effectiveness of APR-246 in combination with pembrolizumab in subjects with solid tumor malignancies. The study will include a safety lead-in portion followed by a phase 2 expansion portion in specific disease groups.

The purpose of this study is to determine the safety, pharmacokinetics (PK) and recommended Phase 3 dose (RP3D) of RYZ101 in Part 1, and the safety, effectiveness, and PK of RYZ101 compared with investigator-selected standard of care (SoC) therapy in Part 2 in subjects with inoperable, advanced, well-differentiated, somatostatin receptor expressing (SSTR+) gastroenteropancreatic neuroendocrine tumors (GEP-NETs) that have progressed following treatment with Lutetium 177-labelled somatostatin analogue (177Lu-SSA) therapy, such as 177Lu-DOTATATE or 177Lu-DOTATOC (177Lu-DOTATATE/TOC), or 177Lu-high affinity [HA]-DOTATATE.

The purpose of this study is to evaluate the treatment of patients with HER2-positive Gastric cancer (GC) or Gastroesophageal Junction (GEJ) cancer to determine the effectiveness of margetuximab combined with INCMGA00012 (also known as MGA012) (Cohort A) and margetuximab combined with INCMGA00012 or MGD013 and chemotherapy compared to trastuzumab combined with chemotherapy (Cohort B).

The purpose of this study is to compare capecitabine and temozolomide to lutetium Lu 177 dotatate for the treatment of pancreatic neuroendocrine tumors that have spread to other parts of the body (advanced) or are not able to be removed by surgery (unresectable). Chemotherapy drugs, such as capecitabine and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radioactive drugs, such as lutetium Lu 177 dotatate, may carry radiation directly to tumor cells and may reduce harm to normal cells. The purpose of this study is to find out whether capecitabine and temozolomide or lutetium Lu 177 dotatate may kill more tumor cells in patients with advanced pancreatic neuroendocrine tumors.

The purpose of this study is to compare, in a non-inferiority fashion, the progression-free survival (PFS) in patients with metastatic refractory gastric/Gastroesophageal Junction (GEJ) adenocarcinoma receiving the combination of ramucirumab with TAS-102 vs. paclitaxel and ramucirumab.

The purpose of this study is to see how well cabozantinib S-malate works compared with placebo in treating patients with neuroendocrine tumors previously treated with everolimus that have spread to nearby tissues or lymph nodes, have spread to other places in the body, or cannot be removed by surgery. Cabozantinib S-malate is a chemotherapy drug known as a tyrosine kinase inhibitor, and it targets specific tyrosine kinase receptors, that when blocked, may slow tumor growth.

The purpose of this study is to determine the safety and effectiveness of Onvansertib, in combination with FOLFIRI + Avastin, as second-line treatment in adult patients who have metastatic colorectal cancer with a Kras mutation. Participants must have histologically confirmed metastatic and unresectable disease, and previously failed treatment or be intolerant to fluoropyrimidine and oxaliplatin with or without bevacizumab.