ZL-1310 is a new experimental treatment designed to tackle small cell lung cancer (SCLC), a particularly aggressive form of lung cancer. The drug is an antibody-drug conjugate (ADC) that specifically targets a protein called delta-like protein 3 (DLL3), found in high amounts in SCLC and other neuroendocrine tumors. The study aims to evaluate the safety, effectiveness, and other characteristics of ZL-1310 in patients with SCLC that has relapsed or is resistant to platinum-based treatments. Previous attempts to target DLL3 faced challenges, and ZL-1310 seeks to overcome these issues, providing a potential breakthrough in treating SCLC, where current options are limited, and relapse rates are high. The study hopes to shed light on ZL-1310's potential as a novel and more effective therapy for patients facing few alternatives and poor prognoses.
This study will evaluate possible new treatments for advanced stage head and neck cancer. Patients who have undergone surgery to remove their tumor may qualify if the tissue is positive for a specific type of squamous cell cancer. The purpose of this study is to compare the current standard treatment, radiation therapy along with chemotherapy with a drug called cisplatin, to two other treatments. One experimental treatment is radiation therapy along with two chemotherapy agents, docetaxel and cetuximab, and the other experimental treatment is the standard treatment currently used along with the addition of an immunotherapy drug atezolizumab. Patients who qualify for participation will be randomly assigned to one of the 3 treatment groups (done with a computerized system). In the current standard treatment group, participants will receive radiation therapy 5 days per week for 6 weeks, and cisplatin once a week through a vein for the 6-week treatment period. The group receiving doxetaxel and cetuximab (both FDA approved medications for the treatment of certain cancers) will receive the same 6 weeks of radiation along with cetuximab through a vein 1 week prior to the start of radiation therapy, and then once a week for the 6 weeks of radiation and the doxetaxel will also be given through a vein once a week for the 6 weeks of radiation therapy. The final group will get the current standard treatment with 6 weeks of radiation and 6 weeks of cisplatin, along with atezolizumab through a vein 1 week prior to your starting radiation and then every 3 weeks for a total of 8 doses, There will be twice as many patients in this last group than the other two groups.
Follow-up will be at Month 1 & 3 and then every 3 months for 2 years, and then every 6 months for 3 more years, and then annually for as long as a participant is willing and able. There will be blood tests and CT scans that will occur throughout the study, however they are standard for the type of cancer being treated and how each individual responds to the treatment. The benefit of participation is there may be improved outcomes in this group of patients however the risks involved with receiving new treatments may be more than with the usual standard treatment. Some of the most common side effects that the study doctors know about are infection, nausea, vomiting, diarrhea, pain, tiredness, kidney problems, numbness/tingling in hands and feet. There may be some risks that the study doctors are not aware of at the moment. There will be a total of up to 480 participants across all sites and approximately 24 participants at MUSC.
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.
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 study is for patients who have been diagnosed with non-squamous non-small cell lung cancer (NSCLC). The investigational drug in this study is ivonescimab (AK112). The study drug is an antibody, it blocks two proteins in the body that help cancer cells live, grow and spread. The study drug will be given in addition to pemetrexed and carboplatin. There are two groups that a participant may be assigned to, which group a subject is assigned on will be determined by type of cancer treatments that they have previously received. Treatment Group A will receive the study drug along with pemetrexed and carboplatin. Treatment Group B will receive placebo along with pemetrexed and carboplatin. The drugs will be given via an infusion. There is a 50% chance of being assigned to either group. Participation in the study will last about 36 months. The study consist of a screening visit, treatment visits, and a safety follow up visit.
The purpose of this research is to determine the safety and tolerability, the best dose for future development, as well as antitumor activity of a new antibody drug conjugate (ADC) called MYTX-011. MYTX-011 is a new drug, being studied in humans for the first time for treatment of advanced non-small cell lung cancer. The study team is investigating this drug to help treat lung cancers that are resistant to standard medications. This drug targets a protein called cMET on the cancer cell. MYTX-011 will attach to the cMET and release chemotherapy into the cancer cell.
This research is being done to better understand how anti-cancer drugs affect cells within a tumor. Injecting very small amounts (microdoses) of pembrolizumab alone or in combination with MK-0482 or MK-4830 above may help the developer of these drugs to understand more about how these drugs work and what changes they make on the tumor. Subjects in this study will have their tumor injected with anti-cancer drugs using a CIVO device. The CIVO device delivers microdoses of multiple drugs or drug combinations directly into the tumor. Some of the procedures in this study include ultrasound assisted placement for tumor injection, a mucrodose injection of anti-cancer drugs into the tumor, and surgery to remove the tumor. Participation in the study will take 5 visits over a period if 56 days. The screening portion will be 28 days and the treatment portion will be 28 days from the time of the injection to the time of follow-up contact by the study team.
The study is for patients that have been diagnosed with low-grade non-invasive upper tract urothelial cancer. The investigational drug used in this study is padeliporfin which is injected into a vein. The main purpose of this study is to learn about the effects and safety of an investigational treatment named padeliporfin Vascular Targeted Photodynamic (VTP) Therapy, in treating low-grade non-invasive upper tract urothelial cancer. Participants can expect to be in this study for up to 18 months. The completion of the study will include up to 9 study visits to the study site and 8 phone visits.
This study is for patients that have been diagnosed with Oropharyngeal Squamous Cell Carcinoma. The purpose of this research study is to determine if lower doses of radiation therapy are as effective as the standard higher doses. Participants will have tests and procedures that would be performed as part of regular care. Participants will be assigned to one of three study groups based on your risk for cancer recurrence. Depending on the group assigned, participants receive either standard dose of radiation therapy (RT), a moderately reduced dose of RT, or an extremely reduced dose of RT. During the RT treatment, participants will also receive chemotherapy. Chemotherapy will be given at the same dose used in routine care for everybody in the study. Participants will be in the study for up to 5 years.