The goal of this clinical trial is to characterize the safety, tolerability, dose-limiting toxicities (DLT), and maximum tolerated dose (MTD) or maximum administered dose of MGC028 (if no MTD is defined). The study will enroll adult participants with relapsed or refractory, unresectable, locally advanced of metastatic solid tumors known to express ADAM9.
The main question the study aims to answer is:
* What types of side effects will participants experience when receiving MGC028?
* Can MGC028 cause cancer to shrink, remain stable, or able to control disease progression of participants with advanced solid tumors?
Participants will
* Undergo screening procedures to determine eligibility
* Receive study treatments initially every 3 weeks.
* Have blood samples taken for routine and research tests
* Have other examinations to check heart and lung function, and general health status
* Be asked about any side effects that may be happening or other medications you are taking. The study doctor will provide treatment for side effects, if necessary.
* Have the study doctor assess your tumor status at regular intervals to determine how you are responding to treatment.
This is an open label, single center, single arm phase 1 study to evaluate the safety , tolerability, pharmacokinetics and efficacy and immunogenicity of LCAR-C182A cells targeting Claudin18.2 in the treatment of patients with advanced gastric cancer and Pancreatic Ductal Adenocarcinoma.
RATIONALE: Radiation therapy uses high-energy x-rays and other sources to damage tumor cells. Giving radiation therapy in different ways may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of indium In 111 pentetreotide in treating patients who have refractory cancer.
RATIONALE: Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells an help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of pancreatic cancer by blocking blood flow to the tumor. Giving gemcitabine hydrochloride together with bevacizumab after surgery may kill any remaining tumor cells.
PURPOSE: This phase II trial is studying gemcitabine hydrochloride and bevacizumab to see how well they work compared to gemcitabine hydrochloride alone in treating patients who are undergoing surgery for pancreatic cancer.
Pancreatic cancer is difficult to diagnose early. By the time people have been diagnosed, the cancer has usually spread to other parts of the body (metastatic). The standard treatment is chemotherapy, but other treatments are needed to improve outcomes in people with pancreatic cancer.
In this study, zolbetuximab will be given together with chemotherapy to people with pancreatic cancer. Zolbetuximab attaches to a protein called CLDN18.2 found at high levels on the surface of the cancer tumor. This switches on the immune system to attack the tumor.
Adults 18 years or older with metastatic pancreatic cancer who have not previously had chemotherapy can take part in the study.
There are 2 main aims of this study:
* To check the safety of zolbetuximab, when given with chemotherapy in people with metastatic pancreatic cancer
* To check if people could cope with (tolerate) any medical problems during the study This is an open-label study. This means people in the study and the study doctors will know that people will receive zolbetuximab with chemotherapy. Different small groups will receive lower to higher doses of zolbetuximab with chemotherapy.
Zolbetuximab and chemotherapy will be given through a vein. This is called an infusion. People will receive zolbetuximab on the first day they receive chemotherapy. This will happen every 14 days in a 28-day cycle.
People will receive zolbetuximab and chemotherapy in the study clinic and at home. Also, doctors will check for any medical problems. People will also have a health check including blood tests. On some visits they will also have scans to check for any changes in their cancer.
People will visit the study clinic about 7 days after they stop treatment. They will be asked about any medical problems and will have a health check including blood tests.
After this, people will have several more visits to the study clinic for health checks. The number of visits and checks done at each visit will depend on the health of each person and whether they complete their treatment or not.
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the tumor growth by blocking blood flow to the tumor. Radiation therapy uses high-energy x-rays to kill tumor cells. Gemcitabine and bevacizumab may make tumor cells more sensitive to radiation therapy. Giving gemcitabine together with bevacizumab and radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving gemcitabine together with bevacizumab and abdominal radiation therapy works in treating patients with localized pancreatic cancer.
This is a single arm study evaluating the tolerability and markers of pancreatic cancer with a specially designed medical food restricted in specific amino acids for the dietary management of subjects with locally advanced and unresectable or metastatic pancreatic adenocarcinoma. Subjects who are eligible to receive two FDA approved first line drug therapies, gemcitabine and nab-paclitaxel (gem+nabP), routinely prescribed in combination for pancreatic cancer may be included in this study.
The focus on treatment of COVID19 patients during the Sars-CoV-2 outbreak has most likely implications for the extent and quality of diagnosis and treatment of non-COVID19 patients. Medical care of cancer patients is a particularly sensitive area. To draw holistic conclusions, it is necessary to analyze the provision of healthcare as broadly as possible with regard to the dimensions of access, processes and outcome during the Sars-CoV-2 pandemic. This will be implemented exemplarily for the early detection, diagnosis and treatment of colorectal cancer (CRC) and pancreatic cancer (PaCa) in Saxony. Patients with diagnosis, treatment or early detection measures for type 2 diabetes (T2D), coronary heart disease (CHD) and multiple sclerosis (MS) serve as comparison groups.
* Inclusion
1. Subjects who are males or females ≥ 19 years of age
2. Subjects who have the following history of first-line gemcitabine and nab-paclitaxel among patients with cytologically or histologically proven metastatic pancreatic ductal adenocarcinoma
3. Subjects who can give written informed consent for participation in this trial after receiving explanations of this trial
4. Subjects who have the following laboratory test values:
* bilirubin ≤ 1.5 x ULN (upper limit of normal)
* aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5 x ULN
* serum creatinine ≤ 1.5 x ULNor estimated creatinine clearance ≥ 40 mL/min (Cockcroft-Gault)
* partial thromboplastin time (aPTT) ≤ 1.5 x ULN
* absolute neutrophil count (ANC) ≥ 1,500 cells/µL
* platelet count ≥ 100,000/µL
* hemoglobin ≥ 9.0 g/dL
5. Subjects who have at least a 12-week life expectancy at the Investigator's discretion
6. Subjects who have Eastern Cooperative Oncology Group (ECOG)Performance Status 0-1
* Exclusion
1. Subjects who were treated with surgery, radiotherapy, chemotherapy or investigational therapy within 2 weeks (note: placement of biliary stent is allowed)
2. Subjects who have uncontrolled CNS metastases (patients who require steroids should be on a stable or decreasing dose for at least 2 weeks)
3. Subjects who have any contraindications for 5-FU, leucovorin, or oxaliplatin
4. Subjects who have moderate or severe cardiovascular disease
* Subjects who have myocardial infarction, unstable angina pectoris, New York Heart Association (NYHA) Class III/IV congestive heart failure, or uncontrolled hypertension within 6 months before screening
* Subjects who have major abnormalities at the Investigator's discretion based on electrocardiogram (ECG)and Doppler ECHO results at screening or within 14 days before screening
* Subjects who have increase in brain natriuretic peptide(BNP) or increase in troponin (over 99th percentile upper reference limit) at Screening (based on the normal range of relevant study center)
* Subjects who have risk factors for ascending aortic aneurysm such as genetic disorder and trauma and risk factors for aortic stenosis
* Subjects who have a history of heart or aorta surgery
5. Subjects who have clinically significant gastrointestinal bleeding within 4 weeks before screening
6. Subjects who have a known history or suspected hypersensitivity to any excipients of the investigational product or combination drug(s)
7. Subjects who have received prior treatment targeting the signaling pathway of TGF-β
8. Subjects who have a disease or condition that affects the mechanism of the investigational product, or are currently using or planning to use:
* Drugs that are exclusively or primarily eliminated by cytochrome P-450 isozyme (CYP) including CYP1A2, CYP2B6, or CYP3A4
* Drugs that are exclusively or primarily eliminated by UDP glucuronyltransferase (UGT) 1A1 (UGT1A1)
* Drugs that are substrates for the drug transporter multidrug resistance protein 1 (MDR1) have a narrow therapeutic window or are strong inhibitors of drug transporter MDR1
* Drugs that are strong inhibitors or inducers of CYP2D6 or CYP3A4
9. Subjects who are unable to swallow tablets
10. Subjects who have a history of or are suspected of drug abuse
11. Female subjects of child-bearing potential who have a positive result on a pregnancy test at screening or are unable to agree to use an effective barrier method of birth control to avoid pregnancy during the study period (e.g., sterilization, intrauterine contraceptive device, combination of oral contraception and barrier contraception, combination of other hormone delivery systems and barrier contraception, contraceptive cream, combination of cream, jelly, or form and diaphragm or condom)
12. Subjects, in the opinion of the Investigator, who are unsuitable to participate in the study
13. Subjects who were treated with other investigational products within 28 days before screening or within a period shorter than 5-timesthe half-life of the investigational product
Evaluate the safety and efficacy of mesothelin-targeting UCAR-T cells in the treatment of mesothelin-positive advanced pancreatic cancer
