Santa Fe

Researchers are evaluating tulisokibart as a potential treatment for radiographic axial spondyloarthritis (r-axSpA), a type of arthritis causing pain, stiffness, and inflammation in the spine and pelvis joints, visible on X-rays. This Phase 2b study aims to determine if different doses of tulisokibart improve symptoms better than a placebo, which looks like the study medicine but contains no active drug. The study has two main parts: a 16-week placebo-controlled period where participants receive either tulisokibart or placebo through subcutaneous injections, followed by a 124-week long-term extension divided into a 40-week main extension and an 84-week optional extension. This allows researchers to assess both the short-term and longer-term effects and safety of tulisokibart. Participants will be monitored for their response using the Assessment of Spondyloarthritis International Society (ASAS) 40 response at week 16 as the primary outcome. Throughout the study, researchers will evaluate disease activity and safety while tracking symptoms and any side effects. The total involvement spans up to 140 weeks, including both initial treatment and extension phases.

Researchers are conducting a Phase 1/2a study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of XER-001, an amifostine drug delivered nasoduodenally, combined with stereotactic body radiotherapy (SBRT) in patients with locally advanced pancreatic adenocarcinoma. The study aims to identify the best dose of XER-001 for future research and assess the safety and effectiveness of the combination treatment with increasingly relaxed duodenal radiation dose limits. Participants receive XER-001 administered through the nasoduodenal route alongside SBRT. The study includes a dose escalation phase to test safety and tolerability over 18 months, followed by a dose expansion phase lasting up to 40 months to further assess safety and efficacy. Radiation dose constraints are gradually liberalized during the Phase 2a component to evaluate treatment effects. Throughout the study, patients undergo safety assessments including clinical evaluations, laboratory tests, and electrocardiograms. Researchers monitor treatment tolerability, medication adherence, and adverse events. Participants must complete medically indicated first-line systemic therapy before enrollment and comply with study procedures. The total study duration includes an 18-month dose escalation period and a 40-month combined dose escalation and expansion period, with ongoing safety evaluations.

This trial investigates the safety and effectiveness of rilvegostomig combined with fluoropyrimidine and trastuzumab deruxtecan (T-DXd) compared to trastuzumab, chemotherapy, and pembrolizumab in adults with HER2-positive locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 with a combined positive score of 1 or higher. Additionally, rilvegostomig combined with trastuzumab and chemotherapy is studied separately to understand each component's contribution. This Phase 2, randomized, open-label, global study is conducted at 200-250 sites in about 25 countries. Participants are randomly assigned to one of three arms: Arm A receives rilvegostomig, fluoropyrimidine, and T-DXd; Arm B receives trastuzumab, chemotherapy, and pembrolizumab; Arm C receives rilvegostomig, trastuzumab, and chemotherapy. Treatments are administered mostly by intravenous infusion every three weeks, with capecitabine given orally twice daily. The study compares these treatment regimens to evaluate their effects on the cancer. Throughout the study, participants undergo assessments including tumor measurements, organ function tests, and heart function evaluation to ensure safety and monitor disease progression. The main outcomes measured are progression-free survival and overall survival for up to approximately six years. Researchers will also monitor adverse events and overall health status during and after treatment.

Researchers are investigating the safety and effectiveness of efruxifermin in people with non-cirrhotic nonalcoholic steatohepatitis (NASH) or metabolic dysfunction-associated steatohepatitis (MASH) who have moderate to advanced liver fibrosis (stage 2 or 3). This Phase 3 study is randomized, double-blind, and placebo-controlled, enrolling a total of 1650 participants in two groups to evaluate treatment outcomes. Participants will receive either efruxifermin or a placebo by subcutaneous injection. The study involves two cohorts, with Cohort 1 including patients who have biopsy-confirmed NASH or MASH and specific liver fibrosis and activity scores. The treatment period and detailed dosing schedules are not provided but the study compares the effects of the active drug against placebo. During the study, participants will be monitored for improvement in liver disease status, including resolution of NASH/MASH and at least a one-stage improvement in liver fibrosis after 52 weeks for Cohort 1. Long-term outcomes such as event-free survival will be observed over 240 weeks. Safety and efficacy assessments will be conducted throughout the study period, including evaluations of liver histology and metabolic health.

Researchers are evaluating the safety and effectiveness of combining the drugs glofitamab, gemcitabine, and oxaliplatin in adults in the United States who have relapsed or refractory diffuse large B-cell lymphoma (DLBCL). The study especially includes under-represented racial and ethnic groups. This phase 1 study aims to better understand how these treatments work together and their impact on this type of lymphoma. Participants will receive intravenous glofitamab for up to 12 cycles, with each cycle lasting 21 days. They will also receive intravenous gemcitabine and oxaliplatin for up to 8 cycles, each cycle also lasting 21 days. Before starting these treatments, participants will get intravenous obinutuzumab. If needed, intravenous tocilizumab will be given to manage cytokine release syndrome, a potential side effect. During the study, participants will be closely monitored for any adverse events and their response to treatment will be assessed for up to 3 years. Researchers will collect data on side effects and measure the complete response rate to treatment. Patients will undergo regular evaluations, including scans and laboratory tests, to track the progress of their lymphoma and any treatment effects over time.

Researchers are evaluating the effectiveness of camizestrant compared to standard endocrine therapy in patients with early breast cancer that is estrogen receptor positive (ER+) and human epidermal growth factor receptor 2 negative (HER2-). These patients have an intermediate or high risk of cancer recurrence and have already completed local treatments such as surgery and possibly chemotherapy, alongside at least 2 years and up to 5 years of standard adjuvant endocrine therapy. The study is a Phase III, open-label trial designed to assess outcomes over a long term. Participants will be randomly assigned to receive either camizestrant, an oral selective estrogen receptor degrader, or one of several standard endocrine therapies including tamoxifen, anastrozole, letrozole, or exemestane, administered according to local approved guidelines. The treatment duration for both groups is planned to last 60 months. Eligible patients may have previously used CDK4/6 inhibitors, and the study will specifically include those with intermediate or high risk of recurrence as determined by clinical and biological markers. During the study, participants will be monitored for up to 10 years from the last patient's randomization to evaluate invasive breast cancer-free survival. Additional outcomes include invasive disease-free survival, distant relapse-free survival, overall survival, safety, and clinical outcome assessments. The study involves ongoing assessments of health status, treatment effects, and safety to determine the long-term benefits and risks of camizestrant compared to standard therapies.

Researchers are evaluating the safety and initial effectiveness of CHS-114 combined with toripalimab and/or other standard treatments in adults with advanced or metastatic solid tumors. This phase 1B study focuses on participants with various advanced cancers, including gastric, gastro-esophageal junction, esophageal adenocarcinoma, esophageal squamous cell carcinoma, and colorectal carcinoma. The trial aims to understand how well this combination works and its safety profile in these patient groups. Participants will receive CHS-114 and toripalimab as infusions, sometimes alongside other drugs such as 5 fluorouracil or cisplatin, depending on their specific cancer type and cohort. The study includes different cohorts based on cancer type and prior treatments, with detailed requirements for tumor characteristics and prior therapy history. Tumor tissue samples are collected before and during treatment to support the research. During the study, participants will be closely monitored for any treatment-related side effects from the first dose until 90 days after the last dose, covering up to about 2.25 years. Assessments will include evaluations of tumor response and safety through physical exams, lab tests, and other clinical monitoring. The study collects detailed information to assess both the safety and early effectiveness of the treatment combinations in these advanced cancer patients.

Researchers are investigating the effectiveness and safety of rilvegostomig combined with gemcitabine plus cisplatin compared to durvalumab combined with gemcitabine plus cisplatin as first-line treatments for patients with advanced biliary tract cancer, including cholangiocarcinoma and gallbladder carcinoma. This is a global, phase III, randomized, open-label study focused on patients with unresectable locally advanced or metastatic disease who have not previously received treatment for advanced cancer. The study includes patients with known PD-L1 status and measurable tumors suitable for repeated evaluation. Participants will receive either rilvegostomig intravenously every three weeks along with gemcitabine and cisplatin given intravenously on days 1 and 8 of each 21-day cycle, or durvalumab intravenously every three weeks for up to eight cycles, followed by dosing every four weeks, along with the same chemotherapy regimen. Treatment is designed to evaluate first-line therapy effects, comparing these two immunotherapy combinations alongside standard chemotherapy. Throughout the study, patients will be closely monitored for overall survival, especially in those with PD-L1 expression of 1% or higher, over approximately four years. Assessments will include tumor measurements by CT or MRI using RECIST 1.1 criteria, performance status evaluations, and ongoing safety monitoring. The study aims to understand the impact of these treatments on survival and disease progression in advanced biliary tract cancer patients.

Researchers are evaluating treatments for people with newly diagnosed multiple myeloma who are not candidates for or do not plan to have autologous stem cell transplant as initial therapy. The study compares the effectiveness of two new combination treatments: teclistamab with daratumumab and lenalidomide (Tec-DR), and talquetamab with daratumumab and lenalidomide (Tal-DR), against the standard treatment of daratumumab, lenalidomide, and dexamethasone (DRd). This is a Phase 3 randomized study designed to assess which treatment better controls the disease. Teclistamab, talquetamab, and daratumumab are given as subcutaneous injections, while lenalidomide is taken orally. Dexamethasone can be given either orally or by intravenous injection. Participants receive one of the three treatment combinations as assigned by the study. The treatments are administered regularly over the study period, with close monitoring and follow-up to evaluate outcomes. The study includes up to 9 years of follow-up to track disease progression and survival. Participants will undergo regular assessments including monitoring for disease progression and treatment response. Key measures include progression-free survival from the time of randomization and the presence of minimal residual disease-negative complete response at 12 months. Safety and tolerability are also tracked throughout the study. Total participation time includes treatment and extended observation to assess long-term outcomes and side effects.

Researchers are conducting a phase 1, multicenter, nonrandomized, open-label, first-in-human study to evaluate YL201 in patients with advanced solid tumors. The study is taking place in China and the United States and consists of two parts: a dose escalation phase to determine the maximum tolerated dose and recommended dose, followed by a dose expansion phase to further assess safety and efficacy. This study targets patients whose tumors are unresponsive to current therapies or who have no standard treatment options available. Participants will receive YL201 through intravenous infusion once every three weeks as a treatment cycle. In some groups, YL201 is administered alone, while in others it is combined with atezolizumab on the first day of each 21-day cycle. The dose escalation phase involves careful monitoring to identify dose-limiting toxicities. The dose expansion phase will enroll patients at the established dose to better define safety and evaluate responses, including in prostate cancer and other solid tumors. Throughout the study, participants will undergo regular assessments including laboratory tests, evaluation of tumor response using RECIST criteria, and monitoring of adverse events. Researchers will track the occurrence of dose-limiting toxicities during the first treatment cycle and overall safety up to approximately 36 months. They will also measure prostate-specific antigen response rates in prostate cancer patients and objective response rates in other solid tumors. Participants must comply with scheduled visits and procedures during the study period.