Benowa

This trial is designed for adults diagnosed with metastatic pancreatic ductal adenocarcinoma PDAC who have not yet received systemic treatment for their advanced cancer and have a good performance status. The study evaluates pumitamig, an investigational drug, in combination with chemotherapy to assess its safety and effectiveness. This phase II trial plans to explore different chemotherapy regimens combined with pumitamig to understand their impact on the disease.

Researchers are evaluating IBI343 in people with locally advanced unresectable or metastatic solid tumors in a Phase IaIb, multicenter, open-label, first-in-human study. The trial aims to assess the safety, tolerability, how the drug moves through the body, and its effectiveness. The study includes participants from China, Australia, and the US and involves various stages to find the best dose and combination therapies. IBI343 is given intravenously and the study is divided into multiple parts. Phase Ia includes dose escalation, dose expansion, and dose optimization for monotherapy, with doses adjusted to balance benefits and risks. Phase Ib includes combination therapy with chemotherapy drugs like FOLFIRINOX or mFOLFOX, given every two to three weeks, with randomized groups to determine the optimal dose and safety. Participants will have regular visits for treatment and monitoring, including physical exams, laboratory tests, and imaging to measure tumor response using RECIST criteria. Safety is closely followed through adverse event tracking up to two years, along with assessments of drug levels in the body and immune response. The study also evaluates how tumor markers relate to treatment response, with total participation lasting up to two years.

Researchers are evaluating an experimental drug called REGN7945 combined with another experimental drug, linvoseltamab, in adults with relapsed or refractory multiple myeloma. This is the first time REGN7945 is tested in humans, while linvoseltamab has been studied alone in similar patients. The study aims to assess the safety, tolerability, and effectiveness of REGN7945 with linvoseltamab compared to linvoseltamab alone. It also investigates side effects, the level of drug in the blood, immune response to the drugs, and impacts on pain, symptoms, function, and quality of life. Participants receive either REGN7945 plus linvoseltamab or linvoseltamab alone, administered according to the study protocol. The study includes Phase 1 and Phase 2 periods to evaluate initial safety and anti-tumor activity. Treatment and follow-up may continue for up to 5 years, allowing detailed monitoring of drug effects and participant outcomes. The trial uses a parallel design to compare the two treatment groups without random assignment. During the study, participants undergo regular assessments including blood tests to measure drug levels and immune responses, evaluations of disease status using international criteria, and questionnaires to assess quality of life and symptom changes. Researchers monitor side effects and overall response to treatment over time. The primary outcomes focus on treatment safety and tumor response within the first 12 weeks, while secondary outcomes include long-term safety, drug concentrations, immune reactions, symptom changes, and survival outcomes. Participation may last several years to fully capture these effects.

Researchers are evaluating the safety, how the body processes and reacts to, and the early effects of ATG-037 alone and combined with Pembrolizumab in adults with locally advanced or metastatic solid tumors. This Phase I study aims to find the best dose and understand treatment impacts on patients whose cancer has progressed despite prior immune checkpoint inhibitor therapy. The trial is open-label, meaning both researchers and participants know the treatments being given, and it includes multiple centers to gather diverse data. The study has two main parts Part I involves dose escalation of ATG-037 given orally once daily initially, then twice daily in cycles of 21 days, followed by combination therapy with Pembrolizumab administered every three weeks for up to about two years. Part II explores ATG-037 given twice daily from the start in combination with Pembrolizumab. Pembrolizumab is given as a fixed 200 mg dose every three weeks. The study includes dose escalation and expansion phases to evaluate different dosing and combinations. Participants will undergo regular monitoring including safety evaluations for adverse events up to one year after the last dose. Researchers will measure drug levels in plasma, immune activity markers, and tumor responses using standard criteria. The study assesses outcomes like dose-limiting toxicities, maximum tolerated dose, and response rates to understand treatment effects. Participants are expected to provide informed consent, meet specific health criteria, and participate in scheduled visits and assessments throughout the treatment and follow-up periods.

Researchers are evaluating an experimental drug called odronextamab combined with chemotherapy in adults with Diffuse Large B-cell Lymphoma DLBCL, including those who have not been treated before as well as those with relapsed or refractory disease. The study aims to assess the safety, tolerability, and dosing schedule of odronextamab with chemotherapy, and to compare its effectiveness against the current standard treatment of rituximab combined with chemotherapy. Additional goals include understanding side effects, drug levels in the blood, immune responses to the drug, and impact on quality of life and daily activities. The study consists of three parts Part 1A involves dose escalation to find a safe dose, Part 1B explores two dosing regimens of odronextamab combined with chemotherapy, and Part 2 randomly assigns participants to receive either odronextamab plus chemotherapy Odro-CHOP or rituximab plus chemotherapy R-CHOP. Odronextamab and rituximab are given by intravenous infusion, with chemotherapy drugs including cyclophosphamide, doxorubicin, vincristine, and prednisone or prednisolone administered as part of the treatment regimen. Participants will be closely monitored throughout the study for side effects, disease progression, and response to treatment. Assessments include measuring dose limiting toxicities, treatment-emergent adverse events, progression free survival, quality of life questionnaires, and blood tests for drug levels and antibodies. The study follows participants for up to 5 years to track long-term outcomes and safety, with regular visits and evaluations scheduled during and after treatment.

Researchers are evaluating the safety and effectiveness of different doses of IMG-007 compared to placebo in adults with moderate-to-severe active atopic dermatitis. This Phase 2b, multicenter, randomized, double-blind, placebo-controlled study aims to understand how well IMG-007 works and its safety profile over a period of up to 48 weeks. Participants will receive subcutaneous injections of IMG-007 or placebo according to the study protocol. The study includes multiple dose regimens of IMG-007 and placebo groups, with some placebo participants crossing over to receive IMG-007 later. Treatments follow a parallel group design where different groups receive different doses or placebo. During the study, participants will undergo assessments including Eczema Area and Severity Index EASI scoring and Investigator Global Assessment for Atopic Dermatitis vIGA-AD at baseline and Week 24. Researchers will monitor treatment-emergent adverse events throughout the study. Participants will be followed for up to 48 weeks to evaluate changes in skin condition and safety outcomes during and after treatment.

Researchers are evaluating the safety and effectiveness of BGB-16673 compared to pirtobrutinib in adults with relapsed or refractory chronic lymphocytic leukemia CLL or small lymphocytic lymphoma SLL who have previously been treated with a covalent Bruton tyrosine kinase inhibitor cBTKi. The study is a phase 3, open-label, randomized trial sponsored by BeOne Medicines, aiming to assess treatment options for these patients. Participants are randomly assigned to receive either BGB-16673 or pirtobrutinib, both taken orally. This parallel assignment design compares these two drugs directly. The treatments continue with monitoring up to approximately three years to observe progression-free survival and other outcomes. The study began in September 2025 and is expected to complete in April 2028. During the trial, participants will undergo regular assessments including imaging scans to measure disease status, quality of life questionnaires, and monitoring for adverse events. Outcomes such as overall survival, response rates, duration of response, and time to next treatment are tracked. Safety and quality of life will be evaluated throughout the study period, which may last up to about three years for each participant.

Researchers are evaluating the combination of elranatamab, daratumumab, and lenalidomide compared with the combination of daratumumab, bortezomib, lenalidomide, and dexamethasone in adults with newly diagnosed multiple myeloma who are not candidates for transplant. This phase 3 study aims to determine whether the new combination offers better clinical benefits by assessing safety, tolerability, minimal residual disease negative complete response rates, and progression-free survival. The study has two parts. Part 1 focuses on characterizing the safety and tolerability of elranatamab combined with daratumumab and lenalidomide or with lenalidomide alone, and determining the best dose. Part 2 compares the effectiveness of elranatamab plus daratumumab and lenalidomide against the standard combination of daratumumab, bortezomib, lenalidomide, and dexamethasone in participants with newly diagnosed multiple myeloma. Participants receive study drugs according to their assigned group, and dosing and combinations vary by part and arm. Participants will undergo regular assessments including monitoring of disease status, progression, and response using criteria such as minimal residual disease and progression-free survival. Safety will be monitored through adverse event reporting and laboratory tests. Quality of life will also be evaluated using questionnaires. The study may last up to several years, with follow-up extending up to 97 months to assess long-term outcomes and survival.

Researchers are studying multiple myeloma, a type of blood cancer, to see if the drug elranatamab, alone or combined with daratumumab, can offer more benefits compared to a combination therapy of daratumumab, pomalidomide, and dexamethasone. This Phase 3 clinical trial focuses on people who have already been treated for multiple myeloma, including with lenalidomide. The study also evaluates the safety and activity of elranatamab with daratumumab and assesses infection protection measures for participants. The trial has three parts. Part 1 tests different doses of elranatamab combined with daratumumab to check safety and activity. In Part 2, participants are randomly assigned to one of three groups elranatamab alone, elranatamab plus daratumumab, or the combination of daratumumab, pomalidomide, and dexamethasone. Part 3 examines how increased infection prevention affects those treated with elranatamab alone or with daratumumab. Treatments are given until the disease worsens, side effects become unacceptable, or participants choose to stop. Participants will be monitored for side effects, disease progression, and overall response using standardized criteria from the International Myeloma Working Group. Safety is closely watched, especially in early treatment phases, and quality of life is assessed with questionnaires. Outcome measures include progression-free survival, response rates, adverse events, and lab results. Participant involvement may last up to 51 months with regular evaluations during the study.

Researchers are evaluating an experimental drug called odronextamab combined with lenalidomide in adults who have relapsed or refractory follicular lymphoma FL or marginal zone lymphoma MZL, which are subtypes of Non-Hodgkins lymphoma. The study aims to assess the safety, tolerability, and proper dosing of this new combination and compare its effectiveness to the current standard treatment of rituximab combined with lenalidomide. The research also explores side effects, drug levels in the blood, immune responses to the drug, and impacts on quality of life and daily functioning. The study has two parts Part 1 is a safety phase where all participants receive odronextamab plus lenalidomide to determine the appropriate dose. Part 2 is randomized and compares two groupsone receiving odronextamab with lenalidomide, and the other receiving rituximab with lenalidomide followed by lenalidomide alone. Participants receive these treatments according to the study protocol during these phases. Throughout the study, participants will undergo various assessments including safety monitoring for side effects, measurement of drug concentrations and immune responses, imaging scans to evaluate disease status, and quality-of-life questionnaires. The primary outcomes include tracking dose-limiting toxicities up to 35 days and treatment-emergent adverse events up to 2 years. Longer-term outcomes such as progression-free survival and overall survival will be followed for up to 5 years, with ongoing evaluations to understand the treatments impact over time.