Heidelberg

Researchers are evaluating the safety, effectiveness, optimal dose, and behavior of an investigational drug called BNT326, alone or combined with other immunotherapy agents, in adults with advanced solid tumors. This study includes patients with tumors that have either spread metastatic, returned after treatment, or progressed despite previous therapies, across various cancer types such as melanoma, lung cancer, breast cancer, gastric cancer, colorectal cancer, and cervical cancer. Participants are divided into two parts Part 1 tests BNT326 alone in different tumor-specific groups, some with dose randomization to find optimal dosing. Part 2 evaluates BNT326 alone or combined with another investigational drug called pumitamig in several cancer types, with some groups receiving randomized doses and others non-randomized treatments. Treatments are given via intravenous infusion, with some oral medications combined in Part 1. The study includes dose escalation and randomization phases, and treatment can continue for up to 24 months or until disease progression or other reasons. During the study, participants undergo screening, treatment, safety follow-up, efficacy follow-up, and long-term survival monitoring phases. Researchers assess adverse events, treatment responses, disease progression, and drug behavior in the body using clinical evaluations and laboratory tests. Follow-up assessments occur up to approximately 38 months for Part 1 and 48 months for Part 2, with continued treatment possible for those benefiting from the therapy. The study aims to gather comprehensive data on safety, dosing, and effectiveness in this patient population.

Researchers are evaluating the efficacy and safety of trontinemab in people with early symptomatic Alzheimers disease, ranging from mild cognitive impairment to mild dementia due to Alzheimers. This Phase III trial aims to understand how trontinemab affects cognitive decline and disease progression in this population. Participants are randomly assigned to receive either intravenous trontinemab or a placebo in a parallel-group design. Treatment is administered by IV infusion, and the effects are compared over a period of 72 weeks. The study includes comprehensive safety and efficacy assessments throughout this period. During the 72 weeks of the study, participants will undergo various evaluations including cognitive tests such as the Clinical Dementia Rating-Sum of Boxes CDR-SB, Alzheimers Disease Assessment Scales, brain imaging with PET and MRI scans, and biomarker measurements in cerebrospinal fluid and blood. Safety monitoring includes tracking adverse events, infusion reactions, and antibody development. The study requires participants to have a study partner and to complete all study procedures over this time.

Researchers are studying the safety and effects of VHB937 in people with early Alzheimers disease, including those with Mild Cognitive Impairment due to Alzheimers or mild Alzheimers itself. This randomized, double-blind, placebo-controlled Phase II trial aims to evaluate whether VHB937 can benefit memory, thinking abilities, daily functioning, and brain changes. The study also looks at how the body processes VHB937 and responds to it. Participants receive intravenous infusions of either a low dose or high dose of VHB937, or a placebo, over a 72-week double-blind period. After this, an extension phase follows for further observation. The treatments are given through infusions, and participants are randomly assigned to one of the three groups in parallel. Throughout the study, participants and their study partners attend regular visits for assessments including clinical dementia rating scales, cognitive tests, daily living activities evaluation, and brain imaging biomarkers. Safety is monitored by tracking adverse events and serious adverse events. Blood samples are collected to measure VHB937 levels and immune responses. The total study duration includes the 72-week treatment period plus additional time in the extension phase.

Researchers are evaluating the safety and optimal dose of BNT329, an investigational drug, in people with advanced solid tumors that express the tumor marker CA19-9. The study also aims to assess how well BNT329 works by measuring participant responses and how long the tumor remains stable without growth or spread. Additionally, the study will examine how BNT329 moves through and affects the body. The trial includes up to four parts. Parts A and B focus on increasing doses to study safety and tolerability in participants with various advanced cancers expressing CA19-9 who have not responded well to previous treatments. Part C may be added if safety or effectiveness concerns arise, involving pre-dosing with a CA19-9 targeting antibody before BNT329. Part D tests two selected dose levels in participants with pancreatic ductal adenocarcinoma PDAC who have received prior treatment. Treatment is given as intravenous infusions every 2 or 3 weeks depending on the study part. Participants undergo screening, followed by treatment for up to two years, an end-of-treatment visit, two safety follow-ups, and a survival follow-up until death, withdrawal, or study end. Throughout the study, researchers monitor side effects, dose adjustments, tumor response, and survival. Blood samples will be collected to study drug levels and immune responses. Safety and effectiveness will be assessed up to 36 months from first dose.

Researchers are evaluating BGB-16673, an oral drug, in adults with various types of B-cell malignancies such as marginal zone lymphoma, follicular lymphoma, mantle cell lymphoma, chronic lymphocytic leukemia, Waldenstrm macroglobulinemia, diffuse large B-cell lymphoma, and Richters transformation. This study includes Phase 1 dose finding and safety expansion, followed by Phase 2 expansion cohorts to determine recommended doses and further assess safety and efficacy. The study is divided into several parts, starting with Phase 1 dose escalation to find safe dosage levels, including monotherapy dose escalation and safety expansion in selected doses. Phase 2 involves expansion cohorts where participants receive the recommended doses identified in Phase 1 for further safety and efficacy evaluation. Some cohorts include participants who have not received prior BTK inhibitors, and Japanese participants are also enrolled to assess safety. Treatments are orally administered. Participants will undergo regular assessments including monitoring for adverse events, disease response, and drug concentration levels in the blood at various time points. Researchers will measure outcomes such as overall response rate and progression-free survival over approximately three years. Safety and tolerability will be closely tracked, and quality of life questionnaires will be completed at scheduled intervals. Participation may last several years, including follow-up periods to monitor long-term effects.

Researchers are evaluating BDC-4182, an immune stimulating antibody conjugate, in people with advanced gastric and gastroesophageal cancers. This first-in-human dose escalation study aims to assess the safety and tolerability of BDC-4182 and to find the recommended dose for Phase 2. Participants have cancers that are metastatic or unresectable and have usually undergone prior standard treatments or are intolerant to them. Participants receive escalating doses of BDC-4182 until the maximum tolerated dose is found. Additional participants may join backfill cohorts at cleared dose levels to collect more safety data, followed by an expansion phase at the recommended dose. BDC-4182 consists of an anti-claudin 18.2 monoclonal antibody linked to a TLR 78 dual agonist, given as a single agent. During the study, participants have safety assessments including adverse event monitoring for about two years, with dose-limiting toxicities evaluated within 21 days of treatment. Effectiveness measures like tumor response rates, duration of response, disease control, progression-free and overall survival, and pharmacokinetics of the drug are tracked for up to four years. Biopsies or archival tumor samples are collected, and organ function is monitored. Participation lasts through dose escalation and expansion phases with ongoing safety and outcome evaluations.

Researchers are studying people with idiopathic pulmonary fibrosis IPF or progressive pulmonary fibrosis PPF who have previously taken nerandomilast in another study. The aim is to assess how well patients tolerate long-term treatment with nerandomilast and to evaluate whether it improves lung function and delays worsening symptoms, hospital visits, or death. This open-label extension trial is sponsored by Boehringer Ingelheim and focuses on treatment over an extended period. Participants take nerandomilast tablets for up to 1 year and 10 months while continuing their usual pulmonary fibrosis treatments. The study involves a single treatment group receiving the drug, and no placebo or comparison groups. Regular visits with doctors help monitor health and collect data during this extended treatment phase. Throughout the study, participants undergo regular lung function tests and health assessments to track any adverse events and changes in lung capacity. The main outcome measured is the occurrence of any adverse events for up to about 99 weeks. Secondary outcomes include changes in forced vital capacity and time to worsening of disease symptoms or hospitalization. The study includes ongoing safety monitoring with a total participation time of up to nearly two years.

This research aims to gather long-term safety and effectiveness information for people treated with ibrutinib, a medicine taken by mouth that blocks a specific enzyme called brutons tyrosine kinase. The study focuses on participants who previously took part in ibrutinib studies that have finished and are still receiving ibrutinib treatment, continuing to benefit from it. It is an open-label study, meaning both participants and researchers know the treatment being given. Participants will continue taking ibrutinib capsules daily at the dose they were given in their prior study until the doctor decides the treatment is no longer helpful due to disease progression or side effects, the participant chooses to stop, other treatment options become available, or the study ends. Safety will be monitored throughout, and effectiveness data may be combined with previous study results. No formal testing of hypotheses is planned in this extension. During the study, participants will be regularly monitored for safety and disease status. The main outcome is the number of participants experiencing side effects within 30 days after the last ibrutinib dose or before starting another cancer therapy. Participants may continue treatment until alternative access to ibrutinib is arranged or the study ends, which is planned for December 2029. Researchers will collect ongoing data to understand the long-term effects of ibrutinib treatment.

Researchers are evaluating whether retatrutide and tirzepatide can prevent major adverse liver outcomes in adults with metabolic dysfunction-associated steatotic liver disease MASLD who are at high risk based on non-invasive tests. This Phase 3 randomized controlled trial aims to assess these treatments compared to placebo in about 4,500 adults over approximately 224 weeks. The study is sponsored by Eli Lilly and Company and focuses on liver disease progression and related health measures. Participants will be randomly assigned to receive retatrutide, tirzepatide, or placebo, all administered by subcutaneous injection. The trial includes two placebo groups corresponding to each experimental drug. After completing the main study, eligible participants may join a 2-year extension where all will receive either retatrutide or tirzepatide regardless of their initial assignment. During the study, participants may attend around 25 to 30 clinic visits for health monitoring, study procedures, and assessments of liver function and disease status. Researchers will measure the time to major adverse liver outcomes, changes in liver fibrosis scores, liver stiffness, liver fat content, liver enzyme levels, body weight, and cardiovascular events. Monitoring will continue from baseline through study completion, with detailed evaluations at multiple timepoints including week 104.

Researchers are evaluating the effects of ALN-APP on disease progression in adults with sporadic Cerebral Amyloid Angiopathy sCAA and Dutch-type Cerebral Amyloid Angiopathy D-CAA. This Phase 2 study aims to assess the safety, tolerability, and pharmacodynamics of ALN-APP in these patient groups. The study is sponsored by Alnylam Pharmaceuticals and includes a randomized, double-blind, placebo-controlled design. Participants will receive multiple doses of ALN-APP or placebo administered intrathecally during a 24-month double-blind treatment period. Those who continue into an optional 18-month open-label extension will receive ALN-APP. The study involves two main periods the initial double-blind treatment phase followed by an optional open-label extension. During the study, participants will undergo brain MRIs to measure new cerebral microbleeds and other brain changes. Researchers will also assess cerebrovascular vasoreactivity using functional MRI and measure amyloid precursor protein levels in cerebrospinal fluid. Safety and adverse events will be monitored throughout the up to 50 months of participation, which includes screening, treatment, and safety follow-up.