This study will evaluate the safety and efficacy of intravesical administration of EG-70 in
the bladder and its effect on bladder tumors in patients with NMIBC.

This study study consists of two phases; a Phase 1 dose-escalation to establish safety and
recommended the phase 2 dose, followed by a Phase 2 study to establish how effective the
treatment is.

The Study will include patients with NMIBC with Cis for whom BCG therapy is unresponsive and
patients with NMIBC with Cis who are BCG-nave or inadequately treated.

Genes contain genetic code which tell the body which proteins to make. Many types of cancer
are caused by changes, or mutations, in a gene called KRAS. Researchers are looking for ways
to stop the actions of abnormal proteins made from the mutated KRAS gene. The so-called G12D
mutation in the KRAS gene is common in people with some solid tumors.

ASP3082 is a potential new treatment for certain solid tumors in people who have the G12D
mutation in their KRAS gene. Before ASP3082 is available as a treatment, the researchers need
to understand how it is processed by and acts upon the body. This information will help find
a suitable dose and to check for potential medical problems from the treatment.

People in this study will be adults with locally advanced, unresectable or metastatic solid
tumors with the G12D mutation in their KRAS gene (G12D mutation). Locally advanced means the
cancer has spread to nearby tissue. Unresectable means the cancer cannot be removed by
surgery. Metastatic means the cancer has spread to other parts of the body. They will have
been previously treated with standard therapies or refused to receive those treatments. In
the European Union (EU) and South Korea, people who have refused to receive treatment with
standard therapies cannot take part.

The main aims of the study are: to check the safety of ASP3082 by itself and together with
cetuximab (a common cancer medicine), how well it is tolerated, and to find a suitable dose
of ASP3082 by itself and together with cetuximab.

This is an open-label study. This means that people in this study and clinic staff will know
that they will receive ASP3082.

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. Only people with
colorectal cancer will receive ASP3082 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, other different small groups of people will receive ASP3082 by itself or together
with cetuximab, with the most suitable doses worked out from Part 1. This will help find a
more accurate dose of ASP3082 to use in future studies.

ASP3082, and cetuximab (if used), will be given through a vein. This is called an infusion.
Each treatment cycle is 21 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; they ask to stop treatment; they do not come back for treatment.

People will visit the clinic on certain days during their treatment, with extra visits during
the first 2 cycles of treatment. During these visits, the study doctors will check for any
medical problems from ASP3082 by itself or together with cetuximab. At some visits, other
checks will include a medical examination, echocardiogram (ECHO) or multigated acquisition
(MUGA) scan, blood and urine tests and vital signs. Vital signs include temperature, pulse,
breathing rate, and blood pressure. (Blood oxygen levels will also be checked for people
treated with ASP3082 together with cetuximab.) Tumor samples will be taken during certain
visits during treatment and when treatment has finished.

People will visit the clinic within 7 days after stopping treatment. The study doctors will
check for any medical problems from ASP3082 by itself or together with cetuximab. Other
checks will include a medical examination, echocardiogram (ECHO) or multigated acquisition
(MUGA) scan, urine and blood tests and vital signs. After this, people will continue to visit
the clinic every 9 weeks. This is to check the condition of their cancer. They will do this
until 45 weeks after treatment stopped, or if their cancer is worse, they start other cancer
treatment, they ask to stop treatment, or they do not come back for treatment.

Also, people may visit the clinic at 30 days and 90 days after stopping treatment. At the
30-day visit, the study doctors will check for any medical problems from ASP3082 by itself or
together with cetuximab. People will have their vital signs checked and have some bloo

This phase II trial investigates how well sacituzumab govitecan and atezolizumab work in preventing triple negative breast cancer from coming back (recurrence). Atezolizumab is a protein that affects the immune system by blocking the PD-L1 pathway. The PD-L1 pathway controls the bodys natural immune response, but for some types of cancer the immune system does not work as it should and is prevented from attacking tumors. Atezolizumab works by blocking the PD-L1 pathway, which may help the immune system identify and catch tumor cells. Sacituzumab govitecan is a monoclonal antibody, called sacituzumab, linked to a chemotherapy drug, called SN-38. Sacituzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as TROP2 receptors, and delivers SN-38 to kill them. Giving sacituzumab govitecan and atezolizumab may work as a treatment for residual cancer in the breast or lymph nodes.

This phase III trial investigates the best dose of vinblastine in combination with selumetinib and the benefit of adding vinblastine to selumetinib compared to selumetinib alone in treating children and young adults with low-grade glioma (a common type of brain cancer) that has come back after prior treatment (recurrent) or does not respond to therapy (progressive). Selumetinib is a drug that works by blocking a protein that lets tumor cells grow without stopping. Vinblastine blocks cell growth by stopping cell division and may kill cancer cells. Giving selumetinib in combination with vinblastine may work better than selumetinib alone in treating recurrent or progressive low-grade glioma.

This phase II trial studies how well inotuzumab ozogamicin works in treating younger patients with B-lymphoblastic lymphoma or CD22 positive B acute lymphoblastic leukemia that has come back (relapsed) or does not respond to treatment (refractory). Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a toxic agent called ozogamicin. Inotuzumab attaches to CD22 positive cancer cells in a targeted way and delivers ozogamicin to kill them.

This phase II trial tests how well neratinib prior to the primary treatment (neoadjuvant) works in treating patients with stage I-III HER2 mutated lobular breast cancers. Neratinib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps slow or stop the spread of cancer cells. Giving neratinib in addition to normal therapy may work better in treating cancer than the endocrine therapy patients would normally receive.

This phase I/II trial studies the side effects and best dose of M3814 and to see how well it works when given together with radiation therapy in treating patients with pancreatic cancer that cannot be removed by surgery and has not spread to other parts of the body (localized). M3814 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Giving M3814 and hypofractionated radiation therapy together may work better than radiation therapy alone in the treatment of patients with localized pancreatic cancer.

This pilot trial compares drug exposure levels using a new method for dosing vincristine in infants and young children compared to the standard dosing method based on body surface area (BSA) in older children. Vincristine is an anticancer drug used to a variety of childhood cancers. The doses anticancer drugs in children must be adjusted based on the size of the child because children vary significantly in size (height, weight, and BSA) and ability to metabolize drugs from infancy to adolescence. The dose of most anticancer drugs is adjusted to BSA, which is calculated from a patients weight and height. However, infants and young children have more severe side effects if the BSA is used to calculate their dose, so new dosing models have to be made to safely give anticancer drugs to the youngest patients. This new method uses a BSA-banded approach to determine the dose. Collecting blood samples before and after a dose of the drug will help researchers determine whether this new vincristine dosing method results in equivalent drug levels in the blood over time in infants and young children compared to older children.

This phase II trial studies the effect of panitumumab-IRDye800 in detecting head and neck cancer during surgery in patients head and neck cancer. Doctors who perform surgery for head and neck cancer are well-trained in removing all of the cancer that can be seen during the operation; however, there are times when there is cancer that is so small that it cannot be seen by the surgeon. Panitumumab-IRDye800 is a combination of panitumumab and IRDye800CW. Panitumumab works by attaching to the cancer cell in a unique way that allows the drug to get into the cancer tissue. IRDye800CW is an investigational dye that, when tested in the laboratory, helps various characteristics of human tissue show up better when using a special camera. Panitumumab-IRDye800 is a combination of the drug and the dye that attaches to cancer cells and appears to make them visible to the doctor when he or she uses the special camera during the surgery. Giving panitumumab-IRDye800 may help doctors better identify cancer in the operating room.

This trial tests the use of a disposable perfusion phantom (P4) to decrease errors in calculating the blood flow of a tissue with DCE-MRI. DCE-MRI is used calculate blood flow of various tissues including tumors. Blood flow often serves as a critical indicator showing a disease status. For example, a pancreatic tumor has typically low blood flow, so it can be used as an indicator to identify the presence of a pancreatic tumor. In addition, an effective therapy may result in the increase of blood flow in a pancreatic tumor during the early period of treatment. Therefore, DCE-MRI may be used to determine whether the undergoing therapy is effective or not by measuring the change of blood flow in the pancreatic tumor and may help doctors decide whether to continue the therapy or try a different one. Unfortunately, the measurement of blood flow using DCE-MRI is not accurate. The use of an artificial tissue, named "phantom" or P4, together with a patient may help to reduce errors in DCE-MRI because errors will affect the images of both the patient and the phantom. Because it is known how the blood flow of the phantom appears when no errors are present, the phantom may be used to detect what kinds of errors are present in the image, how many errors are present in the image, and how to remove errors from the image.