Mineola

Researchers are investigating whether sacituzumab tirumotecan alone or combined with other treatments can treat certain advanced or unresectable gastrointestinal cancers, including colorectal cancer, pancreatic ductal adenocarcinoma, and biliary tract cancer. The study aims to understand the safety and tolerability of sacituzumab tirumotecan and how well the cancer responds to these treatments. Participants will receive sacituzumab tirumotecan in different dose levels either combined with chemotherapy every two weeks in a 4-week cycle, alone every two weeks in a 4-week cycle, or combined with cisplatin and pembrolizumab in a 3-week cycle. Treatment continues until the cancer worsens or participants cannot tolerate it. Cisplatin is given up to approximately six months, and pembrolizumab is administered for up to about two years in the combination group. During the study, participants will have regular assessments to monitor safety, side effects, and how the cancer responds via imaging and clinical evaluation. Researchers will track dose-limiting toxicities, adverse events, treatment discontinuations due to side effects, and objective response rates. Additional measures include duration of response, progression-free survival, and overall survival, with monitoring lasting up to approximately 63 months.

Researchers are evaluating the effectiveness and safety of an investigational drug called BNT323 also known as DB-1303 compared with standard chemotherapy in women with recurrent endometrial cancer. The study includes two groups based on the level of HER2 protein in the tumor Cohort 1 with HER2 levels 1 or 2 who have been previously treated with immune checkpoint inhibitors, and Cohort 2 with HER2 level 3. The study aims to understand how well BNT323 or chemotherapy controls cancer progression and how the drug affects patients immune response and quality of life. Participants in Cohort 1 will be randomly assigned to receive either BNT323 or chemotherapy drugs such as doxorubicin, paclitaxel, or docetaxel. In Cohort 2, participants will receive BNT323 alone. Treatments are given intravenously and continue until the cancer progresses, unacceptable side effects occur, or consent is withdrawn. The study includes screening, treatment, safety follow-up, efficacy follow-up, and a long-term survival follow-up lasting up to about 53 months. During the study, participants will undergo regular assessments including tumor evaluations, safety monitoring, and quality of life questionnaires. Researchers will measure progression-free survival in Cohort 1 and tumor response rate in Cohort 2. Safety is monitored by tracking adverse effects and drug levels in the body. Participants can expect to be followed for up to 53 months after treatment to assess long-term outcomes and survival.

Researchers are evaluating treatments for germinal center B-cell-like diffuse large B-cell lymphoma GCB DLBCL, a fast-growing blood cancer affecting immature B-cells. The study compares two treatment combinations to see if more people respond to zilovertamab vedotin MK-2140 plus R-CHP versus polatuzumab vedotin plus R-CHP. This Phase 2 trial aims to assess the effectiveness and safety of these regimens in participants with newly diagnosed GCB DLBCL. Participants receive either zilovertamab vedotin along with rituximab, cyclophosphamide, doxorubicin, and prednisone R-CHP, or polatuzumab vedotin combined with R-CHP. Treatments are given by intravenous infusion on Day 1 of each 3-week cycle for up to 6 cycles, approximately 4 months, with prednisone or prednisolone taken orally for 5 days of each cycle. For participants with high-risk DLBCL, up to 2 additional cycles of rituximab or biosimilar are given. During the study, participants are monitored for response to treatment using Lugano Response Criteria, with follow-up lasting up to about 31 months for the primary outcome. Secondary outcomes include progression-free survival, overall survival, event-free survival, duration of complete response, adverse events, and quality of life assessments. Safety and health status are regularly checked through exams, lab tests, and questionnaires over several years, with total study participation extending up to 7 years.

The trial investigates the use of EscharEx, a proteolytic enzyme gel, compared to a placebo gel in treating venous leg ulcers VLU in adults. The goal is to evaluate how well EscharEx works and how safe it is for removing dead tissue debridement and preparing the wound bed for healing. This study involves adult patients who have VLUs with specific size and duration criteria. Participants will be randomly assigned to receive either EscharEx EX-03 5% formulation or a placebo gel. The treatment involves applying a gel made by mixing a sterile powder with water to the wound area. The study lasts up to 29 weeks and includes several phases a screening period, up to 8 daily visits for debridement within 2 weeks, weekly wound management visits for up to 12 weeks including wound closure confirmation, and monthly visits over 12 weeks to monitor wound closure durability. During the study, patients will undergo regular clinical assessments of the wound, including visual checks for complete debridement and wound closure, as well as evaluations of healthy tissue growth. The study measures the time taken for complete wound closure and the presence of healthy tissue. Safety and wound healing progress are closely monitored throughout the treatment and follow-up periods, ensuring adherence to the protocol and proper wound management.

Researchers are studying MEN2312, a lysine acetyltransferase 6 KAT6 inhibitor, in adults with advanced breast cancer that is not curable. This first-in-human, phase 1 study evaluates MEN2312 alone and in combination with elacestrant to understand its safety and determine the best dose. Participants have specific genetic alterations in their tumors and have received prior endocrine therapy and cyclin-dependent kinase 4 and 6 inhibitor treatment. Participants will be randomly assigned to receive either MEN2312 by itself or MEN2312 combined with elacestrant, both given as oral tablets. The study follows a sequential design and aims to identify dose-limiting toxicities and recommend the phase 2 dose over several months of treatment. This includes monitoring drug levels in the body and how the body processes the medications. During the study, participants will have regular assessments to monitor side effects, tumor response, and overall health. These include evaluating the number of dose-limiting toxicities within the first 28 days and tracking response rates, progression-free survival, and overall survival for up to nine months after treatment ends. Researchers will also measure drug concentration and excretion to better understand the treatment effects and safety over time.

This research investigates ASTX030, a combination of azacitidine and cedazuridine, given alone or with venetoclax for people with myeloid neoplasms and acute myeloid leukemia AML. The study includes multiple phases, from early dose-finding stages to larger randomized trials, evaluating the safety, pharmacokinetics, and effectiveness of ASTX030 compared to standard subcutaneous azacitidine. It aims to understand how these treatments work in participants with myelodysplastic syndromes MDS, chronic myelomonocytic leukemia CMML, and AML over approximately eight years. The study involves several treatment arms early phases focus on dose escalation and expansion of oral ASTX030 later phases compare oral ASTX030 to subcutaneous azacitidine in randomized crossover designs. Combination therapy arms test ASTX030 plus venetoclax against azacitidine plus venetoclax with specific dosing schedules over 28-day cycles. Participants may switch treatments after initial cycles. Treatments include oral tablets, capsules, and injections, with some doses taken in a fasted or fed state. Participants will undergo regular cycles of treatment with detailed monitoring including blood tests to measure drug levels and responses, assessments of side effects, and evaluations of disease status. Researchers will track outcomes like drug exposure, response rates, survival, and safety over months to years. This includes measuring DNA methylation changes, transfusion independence, and adverse events. The study is open to adults and includes ongoing safety and effectiveness follow-up.

Researchers are following participants with pediatric-onset hypophosphatasia HPP, a rare bone disease that begins in childhood, to understand how the treatment asfotase alfa works over time. This observational sub-study will track patients at various sites in the United States and possibly other countries for at least five years, focusing on how the body responds to the treatment and any immune-related issues that may affect its effectiveness. All participants will receive asfotase alfa given under standard care, typically as subcutaneous injections. Younger children under 2 years old are recommended to have clinic visits about every three months until they turn two, then about every six months afterward. The study monitors biochemical, clinical, imaging if needed, and quality of life outcomes related to HPP to understand the long-term effects of treatment. Participants will be regularly evaluated over a minimum five-year period, including assessments by their treating physicians to detect any loss of treatment effectiveness or serious immune-related side effects. Data collection will include clinical exams, laboratory tests, functional assessments, and quality of life questionnaires. The study aims to gather detailed information about treatment outcomes and safety in real-world settings over time.

This trial focuses on patients with stage IV pressure ulcers complicated by osteomyelitis. It aims to evaluate the safety, tolerability, and the difference in effects between a new treatment called STIMULAN VG combined with debridement and systemic antibiotics, versus the standard care involving debridement and systemic antibiotics alone. The study is a phase II, open-label, randomized, multi-center trial designed to compare these approaches in treating this condition. Participants are randomly assigned to one of two groups one receives ulcer bursectomy, debridement, insertion of STIMULAN VG into the ulcer cavity, followed by flap or primary closure and peri-operative antibiotics the other group receives the standard care consisting of ulcer bursectomy, debridement, flap or primary closure, and peri-operative antibiotics without STIMULAN VG. The trial evaluates treatment over an 8-week period post-operation. During the study, participants will undergo assessments to determine individual patient success and clinical outcomes at the 8-week follow-up visit. Researchers will monitor safety and tolerability throughout the trial, with evaluations including imaging to confirm osteomyelitis and clinical status related to wound healing. Participants are expected to comply with scheduled visits, treatment plans, and study procedures for the duration of the trial.

Researchers are evaluating the safety and effectiveness of a drug called EIK1001 given intravenously alongside pembrolizumab and standard chemotherapy for patients with stage 4 non-small cell lung cancer NSCLC. This study includes participants with either squamous or non-squamous NSCLC who have not had prior systemic therapy for advanced disease. The study is a global, multicenter, double-blind, placebo-controlled, randomized adaptive Phase 23 trial conducted in two phases and analyzed in three parts including dose optimization, dose expansion, and confirmatory testing. Participants are randomly assigned to one of three groups a placebo combined with standard care, or one of two doses of EIK1001 combined with standard care. Standard care chemotherapy varies by cancer type and may include combinations like pemetrexed with carboplatin or cisplatin for non-squamous NSCLC, or carboplatin with paclitaxel or nab-paclitaxel for squamous NSCLC. The study drugs are given intravenously and participants receive these treatments along with pembrolizumab. The trial aims to monitor several outcomes over multiple years. Throughout the study, participants undergo regular assessments to track progression-free survival, overall survival, and response to treatment for up to 6 to 10 years. Investigators also monitor adverse events for safety up to 2.5 years. Participants will have tumor tissue tested for PD-L1 expression and meet other health and eligibility criteria before starting treatment. The study includes close monitoring of disease progression and treatment effects through evaluations and follow-up visits during and after treatment.

Researchers are evaluating how well JNJ-79635322 works compared with an anti-B-cell maturation antigen BCMAxCD3 bispecific antibody in adults with relapsed or refractory multiple myeloma. This phase 3 study includes participants who have received at least three prior therapies and have progressive disease or insufficient response to their last treatment. The study aims to assess treatment outcomes including overall response and progression-free survival over a period of up to 5 years and 7 months. Participants are randomly assigned to receive either JNJ-79635322 or teclistamab, both given as subcutaneous injections. Treatment continues until disease progression or intolerable side effects occur. These two groups allow comparison of the effects of each drug on disease control and patient well-being during the study. During the study, participants undergo regular assessments to monitor their response to treatment, including laboratory tests to measure disease markers and evaluations of symptoms, functioning, and quality of life. Researchers will track adverse events, immune responses to the drugs, and long-term outcomes such as duration of response and overall survival. The total participation time can extend up to nearly 6 years, with ongoing monitoring of symptoms and quality of life throughout this period.