This study involves research, and participation is voluntary. The purpose of the study is to see if a single dose and multiple doses of the study drug, AV 380, are safe and tolerated in cancer participants. This study will also help to look at how AV 380 behaves inside the human body (called pharmacokinetics), how the body responds to AV 380 (called pharmacodynamics), and how the immune system responds to AV 380 (called immunogenicity) when administered along with the standard anticancer treatment that a participant would usually receive if they were not in this study. First, the participant will have some tests to decide if it is safe for to join the study. These tests include blood and urine sampling, electrocardiogram, vital sign measurement, physical examination, cachexia assessment,which checks changes in proteins that affect appetite and computed tomography (CT) scan. If the study doctor thinks a participant is eligible to join, they will be assigned to one of 5 cohorts (a group of people with shared characteristics) (corresponding to 5 dose levels of AV 380) in which then they will receive AV 380 together with the Standard of Care treatment chemotherapy. Participants will need to visit the study site approximately every 1 week for the first 8 weeks and then every 2 weeks. In addition to the above-mentioned tests, then they will be also asked to have exercise tests and complete questionnaires during the study. Participants will also have post study treatment follow up visits 3 times after completion or discontinuation of AV 380. The total duration of the study is up to 7 months (including follow-up visits). Some reasonably foreseeable risks or discomforts with this study include chills, headache, and elevations in an enzyme called creatine phosphokinase which is found mainly in the heart, brain, and skeletal muscle. There is no direct benefit with participating in this study, but the information we get from this study will us improve treatment for people in the future.
They study is for patients that have have been diagnosed with platinum-resistant or platinum-refractory ovarian cancer (PRROC) which includes fallopian tube cancer and peritoneal carcinomatosis (a form of cancer that affects the thin membrane that surrounds your abdominal organs). The investigational drug used in this study is Olvi-Vec. The main purpose of the study is to determine how women diagnosed with PRROC will best respond to receiving Olvi-Vec followed by platinum-doublet chemotherapy (platinum-based chemotherapy such as carboplatin or cisplatin are given with a non-platinum based chemotherapy, including gemcitabine, paclitaxel, docetaxel, nab-paclitaxel, or pegylated liposomal doxorubicin [PLD]) along with bevacizumab, known as the Experimental Arm. Participants can expect to be in this study for up to 36 months.
This research is all about investigating a potential treatment for a specific type of advanced lung cancer. The cancer cells have a protein called c-Met that's acting a bit too excited, driving the cancer to spread and resist treatment. This study focuses on two treatments: one is called Telisotuzumab Vedotin (ABBV-399), which is a smart combination of an antibody and a drug that can stop this protein's activity. The other treatment is called Docetaxel. The researchers have already found in smaller studies that Telisotuzumab Vedotin could be promising for this type of cancer, especially in patients whose previous treatments didn't work well. Now they want to see if it can really make a difference in the long run. They'll be comparing Telisotuzumab Vedotin and Docetaxel to figure out which one is better at helping patients live longer without their cancer getting worse. In this study, participants will be randomly divided into two groups, like flipping a coin. One group will get a new medicine called telisotuzumab vedotin through a vein in their arm every two weeks. The other group will receive a treatment called docetaxel through a vein every three weeks. People in both groups will keep getting their assigned treatment until their doctors say it's time to stop based on certain criteria. Throughout the study, participants will have scans like X-rays or MRIs to see how their tumors are doing. These scans will happen at the beginning and then every few weeks for the first year, and less often as time goes on.Even if someone stops their treatment for a reason other than their cancer getting worse on these scans, the researchers will keep track of them until their cancer gets worse or until they decide they don't want to be in the study anymore.The whole study is expected to last around 38 months, which is a little over 3 years. They'll keep following up with the participants, either by talking to them, checking their medical records, or other appropriate methods, until the participants decide to leave the study or pass away. This study is a big step towards finding better options for people battling this tough form of lung cancer.
The purpose of this study is to evaluate investigational treatments (study drugs) for metastatic esophageal carcinoma to determine if any of these study drugs improve overall survival as compared to standard treatments. The study drugs used in this trial are lenvatinib (E7080/MK‑7902), also called LENVIMA, and pembrolizumab (MK‑3475), also called KEYTRUDA or pembro. Both lenvatinib and pembrolizumab have been approved by the U.S. Food and Drug Administration (FDA) to treat various cancers but may not be approved for your type of cancer. Treatment for this study may be up to 3 years. The procedures include blood and urine samples, questionnaires, infusions, and CT scans. Risks include itchy skin, loose stools, cough, and joint pain. You may or may not receive a direct benefit from participating in this trial, however, information learned from the trial may help other people in the future.
The purpose of this study is to evaluate investigational treatments (study drug) for unresectable metastatic colorectal cancer to determine if any of these study treatments improve overall survival as compared to standard treatments. The goal is to determine the optimal dose level, safety, and tolerability for the study drug ABBV-400 in combination with fluorouracil, folinic acid, and bevacizumab. The study consists of two stages, Stage 1 - Safety Lead-In Dose Escalation and Stage 2- Dose Optimization. ABBV-400 is not FDA approved. Bevacizumab is FDA approved by the U.S. Food and Drug Administration (FDA) to treat various cancers but may not be approved for your type of cancer. Treatment for this study may be up to 3 years. The procedures include blood and urine samples, questionnaires, infusions, and CT scans. Risks include diarrhea, nausea, vomiting, fatigue, and numbness, tingling, or weakness in arms and legs. You may or may not receive a direct benefit from participating in this trial, however, information learned from the trial may help other people in the future.
This project is being conducted in subjects that have been diagnosed with myelodysplastic syndromes (MDS), MDS/myeloproliferative neoplasms (MPN) including chronic myelomonocytic leukemia (CMML), or acute myeloid leukemia (AML) who are candidates to receive treatment with single agent azacitidine based on local country approvals and/or local The study is designed to move efficiently from Phase 1 to Phase 3. This study is testing investigational drug called ASTX030. Investigational means that it is not approved by the Food and Drug Administration (FDA), but it is undergoing testing to find out if it is safe and effective. ASTX030 is a combination of two medicines, azacitidine and cedazuridine, given by mouth. The primary purpose is to test the levels of the investigational drug ASTX030 in your blood, including if food has an effect (Phase 1B only), the safety and tolerability of the drugs, and how subjects respond to the drug. The subject may remain in the study about 3 years. If you benefit from treatment, you may receive study drugs as long as you continue to benefit. If you develop side effects to the study drugs that prevent you from continuing treatment, or if your study doctor believes it is in your best interest to stop the study drug(s), you may be asked to stop the study treatment. After you stop treatment, the Sponsor will continue to collect health information to evaluate long-term effects of the study drugs.
This study is enrolling subjects with advanced solid tumors with the TP53 Y220C alteration in cancer cells. This alteration is a mutation of the tumor that can be found through laboratory tests that use a sample of tissue, blood, or other fluids to check for signs of cancer. This study involves research testing the safety, best dose, side effects and timing of the study drug called PC1486. You will take the study drug, PC14586, in the form of a tablet. If assigned to the combination treatment arm (Part 1), you will also be given pembrolizumab as an intravenous (IV) infusion. Pembrolizumab is a type of immunotherapy that is FDA approved to treat your kind of cancer. The study drug PC1486 is not approved by the Food and Drug Administration (FDA). This study drug targets the TP53 Y220C genetic alteration in tumor cells. During the pre-screening portion, participants will provide either archived tissue or a fresh tumor sample to test for the genetic alteration. If the participants show the genetic tumor alteration in the cancer cells, they may be asked to participate in the trial. Treatment arms are groups or subgroups of participants in a clinical trial. This study will have two arms: one studies PC1486 alone and the second arm studies PC1486 in combination with Pembrolizumab against advanced solid tumors. PC14586 is a small molecule (chemical) that is designed to act on the genetic alteration TP53 Y220C in cancer cells to slow the growth of cancer, and it is taken orally. This study involves blood tests, a possible tumor biopsy, CT, and MRI scans. The study will last approximately 6 months of treatment, followed up by a check-up after the first 3 weeks and every 3 months after. Some common risks (observed in greater than 20% of people) include: Nausea, Vomiting, Abnormal liver tests, Abnormal kidney test (possible kidney damage
The study is for patients that have been diagnosed with carcinoma in situ of the bladder (localized bladder cancer, also called "non-muscle invasive bladder cancer") with or without Ta-T1 papillary disease (Ta means that the cancer is only in the innermost layer of the bladder lining, T1 means that the cancer has started to grow into the connective tissue beneath the bladder lining). The investigational drug used in this study is ONCOFID-P-B. The main purpose of this study is to understand if the study medicine ONCOFID-P-B is effective and safe in treating patients with carcinoma in situ of the bladder who have not received benefit from the standard BCG treatment and are not candidates for radical cystectomy. Participants can expect to be in this study for up to 4 years and will include a screening period of up to 4 weeks followed by up to 33 study visits to the study site.
The purpose of this study is to learn about the effects of an experimental treatment called RO7198457. This study is for patients with Stage II or III colon or rectal cancer, which has been treated surgically and with chemotherapy, and your blood has been found to have ctDNA (circulating tumor DNA) during a ctDNA screening test. RO7198457 (autogene cevumeran) is an immunotherapy that is individualized to a tumor and designed to mount an immune response against it. Treatment includes RO7198457 being injected in the vein, physical exams, blood sample collections, and CT scans for up to a year. Risks include fatigue, fever, and headache. Patients may or may not receive direct benefit while on the study, however, information collected during this study will help people with colon and rectal cancer in the future. RO7198457 is considered "experimental" because it has not been approved by the U.S. Food & Drug Administration (FDA) for the treatment of any disease.
The purpose of this study is to assess the feasibility and safety of modified surgical eyeglasses to view bevonescein intraoperatively and the safety of bevonescein as it shows nerve tissue in the body. Bevonescein is an investigational drug being developed to help doctors identify nerves within the body during surgery.
The drug is administered through a vein in the arm and into the blood stream.t Bevonescein then travels through the blood where it makes nerve tissue fluorescent so that it can then be detected by the modified surgical eyeglasses used in this study by a surgeon. This may help the surgeon (study doctor) to tell the difference between nerve tissue and other tissue during surgery. Bevonescein and the modified surgical eyeglasses that your surgeon will wear (ReVealTM 475) are considered investigational because they are not approved by the Food and Drug Administration (FDA) to help with the visualization of nerves during surgery Alternatives to this study can include to undergo surgery without the study drug.
The duration of this study is about 2 months. The procedures of this study include administration of the study drug once (500 mg), collection of blood and urine samples, and ECGs. Surgery will happened as planned by the study doctor but as part of the research, the surgeon will ear modified surgical eyeglasses to view nerves and may take pictures or video clips. The glasses are FDA cleared but the modified filter and its use in combination with bevonescein is considered experimental.
The most commonly expected risks of fluorescein are nausea, vomiting, and stomach discomfort. Because bevonescein is cleared through the urine, there may be a potential risk to the kidneys and renal (kidney) system. The most serious risks of fluorescein may include severe local tissue damage, anaphylaxis, convulsions, cardiac arrest, and death.