Newport Beach

Researchers are evaluating the safety and effectiveness of licaminlimab eye drops compared to a placebo vehicle in adults with Dry Eye Disease DED who have a specific TNFR1 genotype. This study is a phase 2b3, double-masked, randomized, vehicle-controlled trial aimed at understanding how licaminlimab affects symptoms of dry eye in this particular group. Participants first undergo a run-in period using artificial tear drops three times daily for about 14 days. Following this, they are randomly assigned to receive either licaminlimab eye drops or a placebo vehicle, both administered three times daily for 29 days. The study compares these two treatments to assess their impact on dry eye discomfort. During the study, participants eye discomfort severity is measured at the start and after 29 days of treatment, focusing especially on those with the specific genotype. Additional assessments include overall symptom changes regardless of genotype. The study tracks safety and effectiveness over this period, with the total participation lasting approximately 43 days including the run-in and treatment phases.

Researchers are investigating new treatment options for breast cancer that is hormone receptor-positive HR and human epidermal growth factor receptor 2-negative HER2-, specifically for cases that are unresectable locally advanced or metastatic. This type of breast cancer involves cancer cells that depend on hormones like estrogen or progesterone and have low HER2 protein levels. The study focuses on comparing the effects of patritumab deruxtecan against chemotherapy or trastuzumab deruxtecan in patients whose cancer has progressed despite prior treatments. Participants receive either patritumab deruxtecan through intravenous infusions every three weeks for about 13 months or a treatment chosen by their physician, which may include various chemotherapy drugs or trastuzumab deruxtecan, administered according to specific schedules for up to 13 months. The study is randomized and open-label, meaning participants are randomly assigned to one of the treatment groups, and both the patients and researchers know which treatment is given. Throughout the study, participants undergo regular assessments to monitor cancer progression and overall survival for up to approximately 85 months. Researchers evaluate tumor response, duration of response, and changes in quality of life using standardized questionnaires. Safety is carefully monitored by recording adverse events and treatment discontinuations. The goal is to understand if patritumab deruxtecan can improve outcomes compared to current treatment options.

Researchers are investigating new treatments for high-risk, early-stage breast cancer, specifically targeting two types triple-negative breast cancer TNBC and hormone receptor-low positiveHER2-negative breast cancer. These cancers are characterized by low or no HER2 protein and low hormone receptor presence. The study aims to evaluate if adding sacituzumab tirumotecan sac-TMT to pembrolizumab and chemotherapy can better reduce cancer cells in tumors and lymph nodes and improve the length of time patients live without cancer progression compared to pembrolizumab with chemotherapy alone. Participants in this trial receive one of two treatment plans. One group gets sacituzumab tirumotecan intravenously every two weeks plus pembrolizumab every three weeks for 12 weeks, followed by pembrolizumab with carboplatin and paclitaxel for another 12 weeks. After 3 to 6 weeks, surgery and optional radiation therapy take place, followed by pembrolizumab for about 28 weeks. Participants with remaining disease may receive additional treatments chosen by their doctors, including olaparib, capecitabine, doxorubicin, epirubicin, or cyclophosphamide. The other group receives chemotherapy drugs carboplatin and paclitaxel with pembrolizumab initially, then pembrolizumab with cyclophosphamide and doxorubicin or epirubicin, followed by surgery, optional radiation, and pembrolizumab for about 28 weeks, with similar additional options for residual disease. During the study, participants undergo core needle biopsies, receive intravenous infusions of study drugs, and have surgery and possible radiation therapy. Researchers assess outcomes such as the percentage of participants with no detectable cancer cells at surgery pathological complete response, event-free survival up to about 92 months, and overall survival up to nearly 10 years. Quality of life and side effects are monitored through questionnaires and adverse event tracking. The study lasts several years, with various assessments throughout treatment and follow-up periods to gather comprehensive data on treatment effects and safety.

Researchers are evaluating the efficacy, safety, and tolerability of subcutaneous ianalumab in adults with diffuse cutaneous systemic sclerosis, a condition characterized by skin thickening and other systemic symptoms. This Phase 2 study compares ianalumab to a placebo to understand its impact on this disease, aiming to provide new treatment options for affected individuals. The study is sponsored by Novartis Pharmaceuticals and employs a randomized, double-blind design to ensure reliable results. Participants receive either ianalumab or placebo through subcutaneous injections during the initial 52-week treatment period. After this, all participants enter a second 52-week open-label phase where they receive ianalumab. Following treatment, there is a post-treatment follow-up lasting at least 20 weeks and up to 2 years to monitor long-term effects. The study includes a screening period lasting up to 6 weeks before treatment begins. Throughout the study, participants undergo regular assessments including measuring response based on the rCRISS25 scale at Week 52, lung function tests, skin scoring, and disability index evaluations. Blood samples are taken periodically to measure drug levels and antibodies. Safety is closely monitored through adverse event reporting up to Week 208. The total participation time can extend over several years including treatment and follow-up phases.

Researchers are evaluating the safety, efficacy, and optimal dosing of a combination of two investigational treatments, BNT323 trastuzumab pamirtecan and BNT327 pumitamig, in people with advanced breast cancer. This includes those with hormone receptor-positive or -negative, HER2-positive, HER2-low, HER2-ultralow, HER2-null breast cancer, or triple-negative breast cancer. The study is a Phase III multi-site, open-label trial with a focus on advanced breast cancer treatment options. The study has two parts. Part 1 involves dose escalation of BNT323 combined with BNT327 to determine the recommended Phase 2 dose using six different dose levels. Part 2, which begins after Part 1 completion, includes dose optimization and exploratory cohorts. Cohort 1 in Part 2 uses randomization into four treatment arms, including combination therapy at different doses and monotherapies of either BNT323 or BNT327. Other cohorts receive the recommended dose without randomization. Participants will undergo assessments including tumor scans and cardiac function tests, with monitoring for side effects and tumor response up to 36 months. Researchers will track dose-limiting toxicities and treatment-emergent adverse events during early treatment cycles and monitor objective response rates and disease control over time. Safety and efficacy data will be collected through scheduled visits and tumor assessments during and after treatment to evaluate the study drugs effects and tolerability.

Researchers are evaluating a preservative-free version of Bimatoprost ophthalmic solution 0.01% YSBP compared to Lumigan4 bimatoprost ophthalmic solution 0.01% in adults with primary open-angle glaucoma POAG or ocular hypertension OH. The study aims to determine if the preservative-free formulation is not worse than the existing treatment in controlling these eye conditions. This is a Phase 3 clinical trial sponsored by YS Life Science Co., Ltd., focused on treatment effectiveness and safety. Participants are randomly assigned to receive either the preservative-free Bimatoprost YSBP or Lumigan4 eye drops. The treatments are administered as eye drops, and the study uses a parallel design with two groups treated simultaneously. The trial is double-masked, meaning neither participants nor investigators know which treatment is given. The primary treatment period lasts 12 weeks, during which intraocular pressure IOP is closely monitored. During the study, participants undergo regular assessments including IOP measurements at baseline and Week 12. Visual acuity is also evaluated to ensure participants meet vision criteria. The study monitors adherence to the treatment and any side effects. The main outcome measured is the change in intraocular pressure at Week 12 to assess the treatments effect on eye pressure control. The total study duration extends through the treatment period and concludes by December 2027.

Researchers are evaluating AV-380, an immunoglobulin G1 monoclonal antibody designed to bind human growth differentiation factor 15 GDF-15, a cytokine involved in cancer-induced cachexia. This phase 1B open-label dose escalation study aims to assess the safety, pharmacokinetics, pharmacodynamics, and immunogenicity of AV-380 in cancer patients who have cachexia and elevated GDF-15 levels. Participants have metastatic solid tumors and are actively receiving standard of care chemotherapy. Participants receive AV-380 through intravenous infusion in ascending dose cohorts alongside their standard chemotherapy treatments. The study includes a dose escalation phase where the safety and appropriate dosage of AV-380 are evaluated. This phase allows researchers to monitor the effects of increasing doses of AV-380 over a study period of up to 4 months while patients continue their usual cancer therapies. During the study, participants will undergo assessments including monitoring for adverse events, toxicity, and laboratory abnormalities from enrollment until about 60 days after the last dose. Pharmacokinetic measures such as maximum concentration Cmax, time to maximum concentration Tmax, and area under the curve AUC will also be evaluated. The total involvement includes regular evaluations to track safety, drug behavior in the body, and immune responses to AV-380.

Researchers are evaluating how cannabis use affects the quality of life in patients with multiple myeloma who are receiving chemotherapy. This observational study compares patients who use cannabis with those who do not, aiming to understand both potential benefits and harms. It uses specific tools like the Functional Assessment of Cancer Therapy-Multiple Myeloma FACT-MM and patient-reported symptoms to assess these effects over time. Participants are divided into two groups one group completes surveys and provides blood samples throughout the study, and the other group consists of healthcare providers who complete a survey related to the study. The study follows participants for up to one year, focusing on longitudinal patterns in quality of life and the potential therapeutic benefits and adverse effects associated with cannabis use. During the study, patients complete questionnaires and provide blood samples regularly. Researchers monitor their symptoms and any side effects using standardized scales such as the Edmonton Symptoms Assessment Scale and Common Terminology Criteria for Adverse Events. The study tracks changes over time to better understand how cannabis use interacts with cancer-directed treatments and overall patient well-being.

Researchers are exploring a new multiplex ELISA assay to improve the non-invasive detection of bladder cancer BCa in patients who have microscopic hematuria, a common sign of BCa. This study aims to validate this diagnostic test, which targets a BCa-associated signature in urine samples, to overcome limitations of existing urine-based tests that miss many early or low-grade cancers. Detecting BCa early is crucial since current methods often require invasive bladder examinations. The study involves collecting voided urine samples from patients with microscopic hematuria and analyzing them using the multiplex ELISA assay. The performance of this assay will be compared to standard diagnostic procedures, including cystoscopy, which involves inserting a camera into the bladder, and other urine tests like VUC and NMP-22 BladderChek. This comparison will help confirm the sensitivity and specificity of the new assay within one year. Participants will provide urine samples and undergo cystoscopy and upper tract imaging as part of the hematuria evaluation. Researchers will measure how accurately the multiplex ELISA assay detects bladder cancer compared to current methods. The study includes monitoring for diagnostic performance over a year, with participants expected to complete the full hematuria evaluation during that time. The total duration of participation varies but centers on the one-year outcome assessment.

Researchers are conducting a Phase 1 study to evaluate BHV-1530 alone and in combination with cemiplimab in adults with advanced or metastatic solid tumors. This first-in-human, open-label trial aims to determine the safety, dosing, and potential benefits of BHV-1530 for patients whose cancer has progressed after standard treatments or who have no other available therapies. The study focuses on specific cancers including urothelial cancer, non-small cell lung cancer, and head and neck squamous cell carcinoma, especially those with certain genetic alterations. Participants will receive BHV-1530 as an intravenous infusion on Day 1 of each 21-day cycle, either alone or combined with cemiplimab given on the same schedule. The study includes dose escalation, expansion, and optimization phases to find the maximum tolerable dose and recommended dose range. Some groups may receive the drug alone, while others receive it combined with cemiplimab, with treatment continuing over multiple cycles as determined by the study protocol. During the trial, participants will have regular assessments to monitor safety and treatment effects, including tumor measurements according to RECIST 1.1 criteria and performance status evaluations. Researchers will collect tumor tissue samples, perform laboratory tests, and monitor drug levels in the blood. The main outcomes include determining optimal dosing, safety profile, and clinical benefit rates over an estimated 48 months. Participants health and response to treatment will be carefully followed throughout the study period.