Benowa

Researchers are evaluating IBI343, a new investigational drug, in a Phase Ia/Ib, multicenter, open-label study involving participants with locally advanced unresectable or metastatic solid tumors. The study aims to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of IBI343. Participants include those with various solid tumors who have failed or are intolerant to standard therapies, and the study is conducted across multiple countries including China, Australia, and the US. The study includes several parts, including dose escalation, dose expansion, dose optimization, and combination therapy cohorts. IBI343 is administered intravenously every 21 days or every 14 days depending on the study part. Combination therapies with chemotherapy regimens such as FOLFIRINOX/mFOLFIRINOX and mFOLFOX are included in certain cohorts. The study has an initial safety lead-in phase to confirm tolerability, followed by randomized dose optimization stages to determine the recommended Phase 3 dose. Treatments are given in cycles, with specific dosing schedules for each drug involved. Participants will undergo regular assessments including physical exams, vital sign monitoring, laboratory tests, and imaging to measure tumor response based on RECIST criteria. Researchers will track adverse events, dose-limiting toxicities, and treatment-emergent side effects up to 90 days after the last administration, with some outcome measures followed for up to 2 years. The study focuses on determining the objective response rate and safety profile of IBI343 while monitoring participant health and treatment effects throughout the study duration.

Researchers are studying the safety, tolerability, and effectiveness of 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 being tested in humans, while linvoseltamab has been previously studied alone in similar patients. The study aims to compare the combination treatment to linvoseltamab alone and explore side effects, treatment benefits, drug levels in the blood, immune responses, symptom changes, and quality of life. Participants receive either REGN7945 combined with linvoseltamab or linvoseltamab alone, given according to the study protocol. The study involves multiple treatment cycles, with careful monitoring of how the drugs are administered and how patients respond. The research includes both Phase 1 and Phase 2 components to assess initial safety and preliminary anti-tumor activity. During the study, participants undergo regular assessments including safety evaluations, response measurements using established criteria for multiple myeloma, and monitoring for side effects over up to five years. Researchers collect data on how well patients respond to treatment within 12 weeks of starting, track adverse events, and observe longer-term outcomes. The study also looks at patients' pain, function, and overall quality of life throughout their participation.

Researchers are investigating ATG-037 alone and in combination with Pembrolizumab for patients with locally advanced or metastatic solid tumors. This Phase I, multi-center, open-label, dose-finding study aims to evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of these treatments. The study includes patients with unresectable Stage III or IV melanoma who have progressed after prior immune checkpoint inhibitor therapy, excluding mucosal and uveal melanoma types. The study consists of two parts: Part I involves oral administration of ATG-037 once daily on day -2, followed by twice daily from cycle 1 day 1, with a 21-day treatment cycle. After two cycles of ATG-037 monotherapy, eligible participants receive combination therapy with ATG-037 and Pembrolizumab 200 mg every three weeks for up to approximately two years. In Part II, ATG-037 and Pembrolizumab are administered starting from cycle 1. The study plans to enroll 39-51 subjects for dose escalation in Part 1, up to 18 subjects in Part 2 dose escalation, and 24-34 subjects per dose expansion cohort. Participants will be monitored for adverse events, dose-limiting toxicities, maximum tolerated dose, and recommended phase 2 dose over up to 21 days and one year after the last dose. Assessments include safety monitoring, pharmacokinetic and pharmacodynamic testing, and preliminary efficacy evaluations. The study requires participants to have adequate organ function and an ECOG performance status of 0 or 1, with contraceptive measures for females and barrier contraception for males during and after treatment.

Researchers are evaluating the combination of Elranatamab, Daratumumab, and Lenalidomide compared to Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone in people with newly diagnosed multiple myeloma who are not eligible for transplant. Elranatamab is a bispecific antibody that targets T-cells and multiple myeloma cells to trigger targeted immune cell killing. The study has two parts: Part 1 focuses on safety, tolerability, and optimal dosing of Elranatamab combinations, while Part 2 compares clinical benefits including minimal residual disease negative complete response rates and progression-free survival between the two treatment regimens. In Part 1, participants receive Elranatamab combined with Daratumumab and Lenalidomide or with Lenalidomide alone to determine safe dose levels. This phase includes non-randomized and randomized cohorts. In Part 2, participants are randomly assigned to receive either the combination of Elranatamab, Daratumumab, and Lenalidomide or the combination of Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone. Treatment schedules and doses are managed according to study protocols to evaluate efficacy and safety. Participants undergo regular assessments including monitoring for dose-limiting toxicities in Part 1 from the first dose through 28 days, and in Part 2, evaluation of progression-free survival up to 97 months and minimal residual disease negative complete response at 12 months after randomization. Safety and tolerability are closely monitored throughout the study, with ongoing follow-up to assess treatment effects and outcomes over time.

Researchers are evaluating the study medicine elranatamab alone and in combination with daratumumab for people with relapsed or refractory multiple myeloma who have received prior treatments including lenalidomide and a proteasome inhibitor. The study aims to compare elranatamab to a combination therapy of daratumumab, pomalidomide, and dexamethasone, while also assessing the safety and activity of elranatamab with daratumumab. This is an open-label, phase 3 randomized trial involving multiple centers. The study includes three parts. Part 1 evaluates the safety and activity of different doses of elranatamab combined with daratumumab. In Part 2, participants are randomly assigned to receive either elranatamab alone, elranatamab with daratumumab, or the combination of daratumumab, pomalidomide, and dexamethasone. Part 3 investigates the effect of increased infection protection measures in participants treated with elranatamab alone or with daratumumab. All drugs are given by either subcutaneous injection or orally depending on the medication. Participants will receive study treatment until their disease worsens, unacceptable side effects occur, or they decide to stop. Researchers will monitor safety by tracking dose limiting toxicities during the first 42 days after starting elranatamab and treatment-emergent adverse events during the first 84 days. Progression-free survival will be assessed up to 51 months after randomization. Throughout the study, participants will undergo regular assessments to evaluate treatment safety and effectiveness.

Researchers are studying an experimental drug called odronextamab in combination with lenalidomide for adults with relapsed or refractory follicular lymphoma (FL) or marginal zone lymphoma (MZL), which are subtypes of Non-Hodgkin's lymphoma. This Phase 3 study has two parts: Part 1 focuses on the safety and tolerability of this drug combination and determining the appropriate odronextamab dose, while Part 2 compares the effectiveness of this combination to the current standard treatment of rituximab plus lenalidomide. The study also explores side effects, drug levels in the blood, antibody development against the study drug, and impacts on quality of life and daily activities. Participants receive either odronextamab plus lenalidomide or rituximab plus lenalidomide according to the study protocol. Part 1 is not randomized, focusing on safety and dose finding, while Part 2 is randomized and controlled to assess efficacy and safety. Treatments are administered per protocol guidelines during these study phases. During the study, participants undergo regular evaluations including imaging scans to measure disease, blood tests, and monitoring for side effects up to two years. The main outcomes measured include dose-limiting toxicities within 35 days, treatment-emergent adverse events over two years, and progression-free survival over five years. Participants are also monitored for quality of life and ability to perform daily activities throughout the trial duration.

Researchers are evaluating the safety and early effectiveness of DB-1311 combined with either BNT327 or DB-1305 in adults with advanced or metastatic solid tumors. This phase II, multicenter, open-label trial includes participants with several types of cancer, including hepatocellular carcinoma, cervical cancer, melanoma, head and neck squamous cell carcinoma, platinum-resistant ovarian cancer, and non-small cell lung cancer. The study focuses on targeted patients whose cancers have recurred, progressed, or are difficult to treat. The trial involves two treatment combinations delivered intravenously: DB-1311 with BNT327, and DB-1311 with DB-1305. Participants receive these investigational drug combinations under close observation. The study is divided into two parts: the first part evaluates dose-limiting toxicities within 21 days after the first dose, while the second part assesses treatment safety and response rates up to 72 months. This design allows researchers to monitor both short-term safety and long-term treatment effects. During the study, participants undergo regular assessments including monitoring for adverse events, tumor response evaluations using RECIST criteria, and organ function tests. The primary outcomes include the number of participants experiencing dose-limiting toxicities early in treatment and the objective response rate, which measures the proportion of participants showing significant tumor shrinkage. Safety monitoring continues throughout the study duration, with follow-up visits extending up to six years to observe long-term effects and participant health.

Researchers are studying Tinodasertib, a MNK inhibitor, alone or combined with Pembrolizumab, a PD-1 inhibitor, or Irinotecan, a topoisomerase inhibitor, in patients with locally advanced or metastatic colorectal cancer (CRC). This Phase II trial aims to find the best dose of Tinodasertib and assess its safety, tolerability, and effectiveness when given alone or with these other drugs. The study includes patients who have had previous treatments and focuses on those with specific molecular profiles of CRC. The study has two parts. The first part is a dose escalation run-in to determine the maximum tolerated dose and recommended Phase 2 dose of orally given Tinodasertib, either alone or combined with intravenous Pembrolizumab or Irinotecan. The second part expands the patient group treated at this recommended dose to evaluate clinical activity and safety. Treatment regimens involve oral and intravenous medications, with eligibility partly based on prior therapies and tumor characteristics. Participants will be involved for about two years from enrollment, during which researchers will monitor adverse events, serious adverse events, dose-limiting toxicities, and treatment-emergent side effects. Effectiveness will be measured using objective response rates according to established cancer evaluation criteria. The study includes assessments like tumor tissue sampling, imaging for measurable disease, performance status evaluations, and regular safety monitoring throughout the trial.

Researchers are evaluating the safety and effectiveness of a topical gel called zabalafin for treating people with mild to moderate atopic dermatitis, also known as eczema. This Phase 2b study includes two groups: one with mild to moderate atopic dermatitis and another group with mild to moderate atopic dermatitis plus a secondary skin infection. The goal is to compare zabalafin hydrogel against a placebo (vehicle) over a 16-week treatment period. Participants will be randomly assigned to receive either zabalafin hydrogel or a placebo in a 2:1 ratio. The study includes up to 72 participants across 10 sites in Australia. After up to 2 weeks of screening, participants will apply the assigned gel and visit the study site every 2 weeks for the first month, then monthly until the 16-week treatment ends. This double-blind study means neither participants nor researchers know who receives which treatment. During the study, participants will undergo regular evaluations including a clinical assessment using the validated Investigator's Global Assessment scale (vIGA) to measure treatment effects. Researchers will monitor the severity of eczema, skin lesion size, itching intensity, and any side effects. Participants must follow study procedures, including avoiding other topical products on affected skin areas and attending scheduled visits for up to 113 days.

Researchers are investigating ISB 2001 in adults with relapsed or refractory multiple myeloma (R/R MM) who have previously been treated with immunomodulatory drugs, proteasome inhibitors, and anti-CD38 therapies but did not respond or could not tolerate these treatments. This first-in-human, open-label Phase 1 study aims to assess the safety and anti-myeloma activity of ISB 2001, focusing on finding the optimal dose and monitoring adverse effects. The study is divided into two parts: dose escalation and dose expansion. During dose escalation, participants receive increasing doses of ISB 2001 to identify the maximum planned dose. In the dose expansion phase, participants receive injections of ISB 2001 at the determined optimal dose. Treatment continues until the disease progresses, unacceptable side effects occur, stopping criteria are met, or participants decide to withdraw. Throughout the study, researchers monitor treatment-emergent adverse events and dose-limiting toxicities to evaluate safety over up to 18 months. Participants undergo assessments of their disease status, organ functions, and overall health. Safety monitoring includes laboratory tests and clinical evaluations, with follow-up to understand the treatment's impact and tolerability over time.