Miranda

Researchers are evaluating HMBD-501, a HER3-targeted antibody-drug conjugate, in patients with advanced, relapsed, or refractory HER3-expressing solid tumors including melanoma, non-small cell lung cancer, and breast cancer. This Phase 12 trial aims to assess the safety, tolerability, how the drug moves in the body, and early signs of effectiveness. The study is sponsored by Hummingbird Bioscience and includes two parts a dose escalation phase followed by a dose expansion phase. During Phase 1, patients receive increasing doses of HMBD-501 by intravenous injection every three weeks to find the recommended dose for Phase 2. In Phase 2, patients receive this recommended dose to further evaluate the drugs preliminary clinical effects. The dose escalation helps identify the safest and most effective dose schedule for treating these advanced tumors. Participants will have regular visits for treatment, monitoring, and assessments including safety checks and blood tests to measure drug levels. The main outcomes include tracking any side effects during Phase 1 and measuring tumor responses in Phase 2 over about six months. Researchers will also study how the drug behaves in the body and monitor disease control and progression. Participants must follow the visit schedule and study procedures throughout the trial.

Researchers are evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary cardioprotective and anti-tumor activity of a drug called RC220 combined with doxorubicin in adults with locally advanced unresectable or metastatic solid tumors where doxorubicin could be considered a treatment option. This open-label, phase 1 study is divided into two parts to assess dose escalation and dose expansion in patients with advanced solid tumors. The study has two parts Part 1 involves a fixed-dose doxorubicin monotherapy lead-in cycle to assess tolerability, followed by dose-escalating intravenous infusions of RC220 alone and combined with doxorubicin every 21 days to determine the maximum tolerated combined dose MTCD. Part 2 will evaluate the MTCDs safety, tolerability, and preliminary cardioprotective and anti-tumor effects in an expanded group of patients who have not previously received anthracycline treatment and for whom doxorubicin is indicated. Participants will undergo cycles of treatment starting with doxorubicin alone, then RC220 alone, and then RC220 combined with doxorubicin every 21 days until disease progression, unacceptable toxicity, or withdrawal. Throughout the study, safety and tolerability will be closely monitored, and blood and biomarker samples will be collected. The main outcomes include incidence of dose-limiting toxicities, adverse events, and measures of tumor response and cardiac function over up to 12 months.

Researchers are evaluating BGB-26808, alone or combined with tislelizumab, in people with advanced solid tumors that are metastatic or cannot be removed by surgery. This open-label, multicenter, nonrandomized Phase 1 study aims to find the recommended doses of BGB-26808 and assess its safety, tolerability, and early antitumor activity. The study is sponsored by BeOne Medicines, previously known as BeiGene. Participants will receive increasing doses of BGB-26808 either by itself or combined with tislelizumab and chemotherapy, depending on the study phase. BGB-26808 is given daily as an oral tablet, while tislelizumab is administered by intravenous infusion. The study includes a dose escalation phase Phase 1a and a dose expansion phase Phase 1b to evaluate appropriate dosing and response. During the study, participants will be monitored for adverse events and serious adverse events from the first dose until 90 days after the last dose or start of new treatment, for up to about 12 months. Researchers will also measure tumor response rates, duration of response, disease control, clinical benefit, and pharmacokinetic properties like drug concentration in the blood. Study visits will include tumor assessments, blood tests, and safety evaluations over several months.

Researchers are evaluating the effects of subcutaneous injections of pentosan polysulfate sodium PPS compared with placebo in adults experiencing knee osteoarthritis OA pain. This randomized, double-blind, placebo-controlled phase 3 study aims to measure changes in pain and function over a treatment and follow-up period. The study involves participants with knee OA who have not responded to certain existing therapies, and the research is sponsored by Paradigm Biopharmaceuticals Ltd. Participants will be randomly assigned to receive either PPS or a placebo via subcutaneous injections twice weekly for 6 weeks. The study timeline includes a 7-week screening period, a 6-week treatment period, and a 52-week follow-up. Approximately 466 adults will be enrolled, and an interim analysis will occur after half of the participants complete Day 112, with final analyses conducted after all complete Day 404. Throughout the study, participants will visit the study center twice weekly during treatment and approximately every 4 to 6 weeks during follow-up. They will undergo assessments of knee pain using daily pain scores, function evaluations with the WOMAC index, quality of life questionnaires, and imaging tests including MRI and X-rays. Researchers will monitor safety through adverse event tracking and clinical tests. Total participation may last up to 64 weeks.

Researchers are evaluating the combination of capivasertib with CDK46 inhibitors and fulvestrant in adults with hormone receptor-positive and HER2-negative locally advanced or metastatic breast cancer. This Phase IbIII study aims to determine the safe dose for the combination treatment in the initial Phase Ib part and then compare its effectiveness and safety to standard treatment in the Phase III part in participants who have not received prior endocrine therapy in the advanced setting. In the Phase Ib portion, participants receive capivasertib combined with one of the CDK46 inhibitorspalbociclib, ribociclib, or abemacicliband fulvestrant to establish recommended doses. In the Phase III part, participants are randomly assigned to receive either capivasertib plus fulvestrant with a chosen CDK46 inhibitor palbociclib or ribociclib or fulvestrant with a CDK46 inhibitor alone. Treatments are given in 28-day cycles with specific dosing schedules for each drug, including oral doses of capivasertib and CDK46 inhibitors and injections of fulvestrant. Participants undergo screening and regular monitoring throughout the study, including assessments of treatment side effects, tumor progression, and blood samples for pharmacokinetics and biomarker analysis. The primary outcomes include dose-limiting toxicities and adverse events in Phase Ib and progression-free survival in Phase III, with follow-up lasting up to several years to evaluate overall survival, response rates, physical functioning, and quality of life.

Researchers are evaluating KESONOTIDE12, a new drug that inhibits the hGIIA-vimentin protein, in adults with advanced or metastatic solid tumors including prostate, breast, lung, ovarian, glioblastoma, pancreas, and skin cancers. This adaptive phase III trial aims primarily to assess the safety and tolerability of KESONOTIDE12 when given alone. The study also looks at how the drug moves through the body. The trial is open-label and multicenter, enrolling about 20-32 participants in phase I and around 80 in phase II. In phase I, participants receive escalating single doses of KESONOTIDE12 orally at 10mg, 30mg, 60mg, or 120mg to find the best dose with acceptable side effects. Phase II will give participants one of two recommended doses identified earlier, either alone or combined with standard treatments. Treatments are given in 21-day cycles and continue until the cancer worsens, side effects become unacceptable, or other reasons for stopping occur. The adaptive design allows for modifying treatment groups or stopping early based on effectiveness or safety. Participants will be closely monitored with regular assessments including physical exams, vital signs, heart rate, blood pressure, ECGs, laboratory tests, and performance status evaluations. Safety is carefully evaluated in the first 21-day cycle for serious adverse events and dose-limiting toxicities. The study tracks participants until disease progression, withdrawal, or loss to follow-up. The trial runs until October 2027, aiming to provide detailed safety and dosing information for KESONOTIDE12 in solid tumors.

Researchers are evaluating the effectiveness of oral KAI-7535 taken once daily compared to a placebo in adults living with obesity or overweight who have at least one weight-related health condition, excluding those with diabetes mellitus. The study also examines how well KAI-7535 works in participants with type 2 diabetes mellitus. Safety, tolerability, and other weight-related results will be assessed in both groups. Participants will be randomly assigned to receive either KAI-7535 or a placebo once a day. The study includes multiple dosing schedules of KAI-7535 to evaluate its effects. The trial follows a parallel design with a quadruple masking method to ensure unbiased results. The treatment period lasts up to 44 weeks. Throughout the study, participants will have their body weight and body mass index measured at the start and at week 44. Researchers will track the percentage change in body weight and the number of participants achieving weight loss of 5% or 10%. Safety and tolerability will also be monitored. The entire participation period can last over 44 weeks, including screening and follow-up assessments.

Researchers are evaluating the long-term effects of maridebart cafraglutide in adults with obesity or overweight. This extension study follows participants from a previous trial to assess the medications ongoing efficacy, safety, and tolerability over an extended period. The trial is designed as a phase 3 randomized and double-blind study to provide comprehensive information on treatment outcomes. Participants will receive different doses of maridebart cafraglutide administered by subcutaneous injection at varying intervals, including once every 4, 8, or 12 weeks. Some participants who received placebo or lower doses in the previous trial will undergo dose escalation or re-randomization to different dose groups or placebo. The study includes a dose-escalation phase for certain participants before initiating the assigned high dose. During the study, participants will be regularly monitored for changes in body weight compared to the original trial baseline, treatment-emergent adverse events, and serious adverse events. Additional assessments will track waist circumference, quality of life related to weight, and maintenance of weight loss. Participants are expected to complete visits and evaluations over approximately 48 weeks, with safety data collected up to 60 weeks from the start of the extension trial.

This research aims to evaluate the long-term safety and effectiveness of the Rigicon Infla 10 Three-Piece Inflatable Penile Prosthesis in men with erectile dysfunction ED. ED is a common male sexual condition linked to various health issues such as diabetes, cardiovascular disease, and depression, affecting quality of life. The study follows patients implanted with this device for up to three years to assess its impact on ED treatment. Participants receive the Rigicon Infla 10 inflatable penile prosthesis, which is a three-piece device designed to help men achieve and maintain erections. The study involves a single group of male subjects aged 22 and older who have been implanted with this device. Follow-up visits are scheduled at 14 days, 6 weeks, 6 months, 12 months, 18 months, 24 months, and 36 months post-implantation to monitor safety and device effectiveness. During the study, participants will have assessments including device-related safety events, an objective axial rigidity test at 12 months, and evaluations of erectile function and self-esteem using standardized questionnaires. Researchers will monitor participants according to the study protocol and usual care for ED and related health conditions. The total participation period spans up to three years with periodic health evaluations and device durability assessments.

Researchers are studying AU-007 imneskibart, a monoclonal antibody that binds to IL-2 and inhibits IL-2 receptor alpha binding, in patients with unresectable locally advanced or metastatic cancer. This open-label, first-in-human Phase 12 trial aims to evaluate the safety, tolerability, and initial effectiveness of AU-007 alone or combined with aldesleukin, a single loading dose of aldesleukin, or with aldesleukin plus checkpoint inhibitors avelumab or nivolumab. The study includes patients ineligible for or who have progressed on standard therapies. The trial has multiple parts dose escalation arms testing AU-007 alone and in combination with aldesleukin given every two weeks, followed by expansion cohorts focusing on selected cancers like cutaneous melanoma and non-small cell lung cancer NSCLC. Later parts assess AU-007 plus aldesleukin combined with avelumab or nivolumab. AU-007 and other study drugs are administered by intravenous infusion on schedules such as every two or four weeks, depending on the treatment arm. Participants will undergo regular safety assessments, blood tests to evaluate drug levels and immune responses, and tumor imaging to measure disease status. Researchers will monitor side effects and signs of anti-tumor activity from the first dose until 28 days after the last dose. The study includes ongoing evaluations of pharmacokinetics, immunogenicity, and cytokine changes. Total participation lasts until the end of treatment plus safety follow-up, with detailed monitoring throughout.