Chattanooga

Researchers are evaluating BGB-16673, an orally administered Bruton Tyrosine Kinase targeted protein degrader, in adults with various B-cell malignancies including relapsed or refractory forms of marginal zone lymphoma, follicular lymphoma, mantle cell lymphoma, chronic lymphocytic leukemia/small lymphocytic lymphoma, Waldenstrf6m macroglobulinemia, diffuse large B-cell lymphoma, and Richter's transformation. The study aims to find the recommended dose and assess the safety, tolerability, and response rates in this population through a phase 1/2 open-label trial. The trial includes several parts: a phase 1 monotherapy dose finding with dose escalation and safety expansion, followed by phase 2 expansion cohorts. Participants receive BGB-16673 orally at various dose levels to determine the maximum tolerated dose and the recommended dose for further study. Specific groups include Japanese participants and those who have not previously received a Bruton Tyrosine Kinase inhibitor. Dose escalation and safety data are collected to guide dosing recommendations, with some cohorts focused on particular lymphoma subtypes and treatment histories. Participants will be monitored from the first dose of BGB-16673 until 30 days after the last dose or before starting new anticancer therapies, for up to 47 weeks in phase 1 and approximately three years in phase 2. Assessments include adverse event tracking, response rates, pharmacokinetics, and quality of life questionnaires. Various measures such as plasma drug concentration, protein degradation, and progression-free survival are evaluated periodically. Safety and efficacy data support long-term monitoring and dose adjustments throughout the study period.

Researchers are evaluating the effectiveness and safety of two treatments, rilvegostomig and pembrolizumab, each combined with platinum-based doublet chemotherapy, as first-line therapy for patients with metastatic non-squamous non-small cell lung cancer (mNSCLC) whose tumors express PD-L1. The study is a Phase III, randomized, double-blind trial conducted globally at multiple centers. It focuses on patients with tumors expressing PD-L1 at 1% or higher and aims to compare these treatment combinations in this specific lung cancer population. Participants will be randomly assigned to one of two groups. One group receives rilvegostomig intravenously on Day 1 of each 21-day cycle, combined with platinum-based chemotherapy (carboplatin or cisplatin) and pemetrexed, followed by maintenance rilvegostomig plus pemetrexed monotherapy. The other group receives pembrolizumab intravenously on the same schedule with the same chemotherapy drugs, followed by pembrolizumab plus pemetrexed maintenance. Chemotherapy is given for up to four cycles. During the study, participants will be monitored for overall survival and progression-free survival for up to approximately five years. Researchers will also assess response rates, duration of response, pharmacokinetics, immunogenicity, and patient-reported physical function and quality of life. Safety will be carefully tracked throughout the study. The trial began in late 2024 and is expected to conclude around March 2030.

Researchers are evaluating the efficacy and safety of rilvegostomig combined with platinum-based chemotherapy compared to pembrolizumab combined with the same chemotherapy for first-line treatment of patients with metastatic squamous non-small cell lung cancer (mNSCLC) whose tumors express programmed death-ligand 1 (PD-L1) at 1% or higher. This Phase III, randomized, double-blind, global study focuses on patients with squamous mNSCLC without actionable genomic mutations and assesses these treatments over approximately five years. Participants receive either rilvegostomig or pembrolizumab intravenously on Day 1 of each 21-day cycle, combined with carboplatin and paclitaxel or nab-paclitaxel chemotherapy. Chemotherapy is given up to 4 cycles, with nab-paclitaxel administered on Days 1, 8, and 15 of each cycle. After chemotherapy, patients continue with the assigned immunotherapy drug. The study compares these two treatment regimens as first-line therapy. During the study, participants undergo regular assessments including imaging to measure tumor response, survival, and disease progression up to about five years. Researchers also monitor physical functioning, quality of life, lung cancer symptoms, and drug pharmacokinetics and immunogenicity. Safety is closely followed, and overall survival and progression-free survival are the primary outcomes measured to evaluate the treatments' impact.

Researchers are evaluating the safety and effectiveness of combining durvalumab with domvanalimab compared to durvalumab with a placebo in adults who have locally advanced (Stage III), unresectable non-small cell lung cancer (NSCLC) that has not worsened after platinum-based concurrent chemoradiotherapy. This Phase III, randomized, double-blind, placebo-controlled international study aims to understand if adding domvanalimab improves outcomes in this patient group. Participants will receive either durvalumab plus domvanalimab or durvalumab plus placebo as intravenous infusions every four weeks, starting on Day 1, for up to 12 months. The study includes two groups: one receiving the experimental combination and the other receiving durvalumab with placebo. The treatment phase spans a maximum of one year. During the study, participants will be closely monitored through various assessments including tumor tissue analysis and performance status evaluations. Researchers will measure progression-free survival up to 8 years after randomization as the main outcome. Additional outcomes include overall survival, response rates, duration of response, and safety markers. The study involves long-term follow-up to assess durability of outcomes and treatment effects.

Researchers are evaluating whether two drugs, retatrutide and tirzepatide, can prevent serious liver problems in adults with metabolic dysfunction-associated steatotic liver disease (MASLD) who are at high risk based on non-invasive tests. This Phase 3 randomized clinical trial plans to enroll about 4,500 adults and will last approximately 224 weeks, including up to 25 to 30 clinic visits to monitor health and liver disease progression. The study is sponsored by Eli Lilly and Company. Participants will be randomly assigned to receive either retatrutide, tirzepatide, or a placebo, all given by subcutaneous injection. After completing the main study, eligible participants may join a 2-year extension where everyone receives either retatrutide or tirzepatide, regardless of their original group. This Master Protocol evaluates multiple pharmacologic agents under controlled conditions. Throughout the study, participants will undergo various assessments including liver function tests, imaging to measure liver stiffness and fat content, and body weight measurements. Researchers will track the time to major adverse liver outcomes and cardiovascular events. Safety and disease progression will be closely monitored, and the study includes evaluations at baseline, week 104, and up to study completion.

Researchers are evaluating the safety, tolerability, and effect on albuminuria of the drug MZE829 in adults with proteinuric chronic kidney disease who carry the APOL1 high risk genotype. This open-label Phase 2 study focuses on participants with proteinuria and the specific genetic risk factors G1/G1, G2/G2, or G1/G2. The study aims to better understand how MZE829 impacts kidney disease in this targeted group. Participants will receive MZE829 capsules taken orally. The study includes two groups: one with chronic kidney disease and concurrent diabetes, and another with chronic kidney disease without diabetes. The treatment period lasts 12 weeks, during which safety and tolerability will be closely monitored along with the drug's effect on albuminuria. This design allows researchers to assess the drug’s impact across different patient profiles. During the study, participants will be monitored from Day 1 through Week 12 with regular assessments for adverse events and measurement of albuminuria reduction. Researchers will also track plasma drug concentrations to understand how the body processes MZE829. Safety and tolerability will be evaluated based on the incidence of any adverse events throughout the 12-week treatment period. The total duration involves close observation and follow-up during this timeframe to evaluate the study outcomes.

Researchers are evaluating the safety and effectiveness of belzupacap sarotalocan (bel-sar) compared to a sham control in adults with primary indeterminate lesions or small choroidal melanoma. This phase 3 trial aims to establish whether bel-sar, administered via a specialized eye injection, can better manage these eye tumors. The study is carefully designed to keep participants and assessors unaware of the treatment given to ensure unbiased results. Participants receive either a high or low dose of bel-sar through a suprachoroidal microinjector followed by activation with an infrared laser, or they receive sham injections and sham laser treatments as a control. The treatment uses a special device to deliver the drug in the space around the eye, and the laser helps activate the drug. Three study groups are compared: high dose bel-sar with laser, low dose bel-sar with laser, and sham procedures. During the trial, participants will be monitored for up to 65 weeks to assess tumor progression and other outcomes. Researchers will evaluate the time it takes for tumors to progress and other combined measures related to the disease. Safety and treatment effects will be closely observed throughout the study period. The study started in December 2023 and is expected to end in August 2028, with participants involved in scheduled assessments and monitoring visits.

Researchers are evaluating petosemtamab compared with investigator's choice monotherapy in patients with incurable, metastatic or recurrent head and neck squamous cell carcinoma (HNSCC) who have previously received treatment. This phase 3 open-label, randomized, controlled, multicenter study focuses on patients whose disease progressed after anti-PD-1 and platinum-containing therapies. The study aims to assess treatment options for second- and third-line therapy in this challenging condition. Participants will be randomly assigned to receive either petosemtamab or one of several investigator-chosen monotherapies, including cetuximab, methotrexate, or docetaxel. The study compares these treatment approaches without masking, allowing patients and researchers to know the assigned therapies. Treatments will be provided according to the study protocol, with follow-up to monitor effects and safety. During the study, participants will undergo assessments including radiologic evaluations to measure tumor response, laboratory tests to monitor organ function, and quality of life questionnaires. The main outcome is overall survival tracked for up to about three years, with additional measures such as response rate, progression-free survival, and treatment-related side effects observed for up to two years. Safety will be closely monitored, including adverse events and antibody responses, ensuring comprehensive evaluation throughout the study period.

Researchers are investigating the effectiveness and safety of combining petosemtamab with pembrolizumab compared to pembrolizumab alone as first-line treatment for recurrent or metastatic PD-L1 positive head and neck squamous cell carcinoma (HNSCC). This Phase 3 randomized, open-label study focuses on patients who have not received previous systemic therapy for incurable recurrent or metastatic disease and aims to improve treatment outcomes in this population. Participants will be randomly assigned to receive either the combination of petosemtamab plus pembrolizumab or pembrolizumab alone. The study excludes patients previously treated with anti PD-(L)1 or anti-EGFR therapies, with some exceptions for local treatments like cetuximab under specific conditions. The treatments will be administered as part of the trial, with researchers comparing the two approaches over the treatment period. During the study, participants will undergo regular evaluations including tumor assessments based on RECIST v1.1 criteria, health-related quality of life questionnaires, and safety monitoring for adverse events. The main outcomes measured include overall survival and objective response rate up to approximately three years. Additional assessments include progression-free survival, duration of response, and pharmacokinetics. These activities aim to provide comprehensive data on how well the treatments work and their safety profiles throughout the study period.

Researchers are evaluating changes in bone mineral density in premenopausal women with heavy menstrual bleeding caused by uterine fibroids or moderate-to-severe pain from endometriosis. This Phase 3B, open-label study looks at the effects of continuous treatment with a relugolix combination tablet for up to 48 months (4 years), followed by a 1-year period to monitor bone health after stopping treatment. Participants will take a daily oral relugolix combination tablet containing relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg for 4 years. Bone mineral density will be measured every 6 months using dual-energy X-ray absorptiometry (DXA). Some women who have completed a previous related study may join to complete 3 years of treatment. After treatment ends, bone density will be checked again at 6 months and 12 months during the follow-up year. Women in the study will have regular visits for bone density scans and health assessments, including physical and gynecological exams, lab tests, and vital signs. Researchers will track changes in bone density at the spine, hip, and femoral neck throughout treatment and follow-up. They will also monitor for any fractures or adverse events during the 4 years of treatment and the 1-year post-treatment period. Total participation can last up to 5 years including the follow-up.