Miranda

Researchers are evaluating HMBD-501, a HER3-targeted antibody-drug conjugate, in patients with advanced-stage, relapsed, or refractory solid tumors that express HER3. This Phase 1/2, first-in-human, open-label clinical trial aims to assess the safety, tolerability, how the drug moves in the body, and early signs of effectiveness in cancers such as melanoma, non-small cell lung cancer, and breast cancer. The study is divided into two phases. Phase 1 involves gradually increasing doses of HMBD-501 given to groups of patients to find a safe and tolerable dose to use in Phase 2. In Phase 2, patients receive the recommended dose to evaluate the drug’s preliminary effectiveness. HMBD-501 is given as an infusion, and dosing schedules are determined from the Phase 1 results to guide treatment in Phase 2. Participants will have regular visits for treatment, safety monitoring, and assessments, including laboratory tests and scans. Researchers will track side effects throughout the study, which lasts about six months on average per participant. The main outcomes include the frequency of treatment-related side effects in Phase 1 and the tumor response rate to treatment in Phase 2. Participants must follow contraception rules during and after treatment to ensure safety.

Researchers are evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of RC220, a bisantrene formulation, alone and combined with doxorubicin in adults with advanced solid tumors where anthracycline treatment may be suitable. This phase 1, open-label, multi-center study aims to find the maximum tolerated dose of RC220 with doxorubicin and assess preliminary cardioprotective and anti-tumor effects in patients who have not previously received anthracyclines. The study has two parts: Part 1 involves dose escalation where patients receive intravenous RC220 alone on Day 1, then combined with doxorubicin (60 mg/m2 IV) on Day 1 of 21-day cycles, to establish the maximum tolerated combined dose. Part 2 is a dose expansion cohort where patients receive the determined maximum dose combination to further evaluate safety, tolerability, and early efficacy. Treatment continues until disease progression, unacceptable side effects, withdrawal, or study end. Participants will undergo safety and adverse event monitoring including dose limiting toxicities during the first 21-day treatment cycle and tracking of treatment-emergent and serious adverse events up to 30 days after the last dose, with follow-up potentially extending to 12 months. Researchers will assess tumor response per RECIST criteria and collect laboratory tests, imaging, and patient evaluations throughout the study to measure treatment effects and tolerability.

Researchers are evaluating BGB-26808, alone or combined with tislelizumab, in participants with advanced solid tumors in an open-label, multicenter, nonrandomized Phase 1 study. This study aims to find the recommended dosing for BGB-26808 while assessing its safety, tolerability, pharmacokinetics, and early antitumor activity. Participants include those with advanced, metastatic, unresectable, or locally advanced tumors who may have limited treatment options or no prior therapy targeting HPK1. Participants receive BGB-26808 orally once daily as a tablet. Tislelizumab, when used, is given by intravenous infusion. Chemotherapy may also be administered following local guidelines or prescribing information. The study includes dose escalation and dose expansion phases to determine the maximum tolerated dose, maximum administered dose, and the recommended dose for further study. During the study, participants undergo regular monitoring for adverse events and serious adverse events up to about 12 months after dosing or until starting new anticancer therapy. Effectiveness is measured by overall response rate around 6 months. Researchers will collect tumor tissue samples, assess organ function, and evaluate performance status. Participants are followed closely with safety checks and evaluations of treatment response throughout the study duration.

Researchers are investigating the effects of subcutaneous injections of pentosan polysulfate sodium (PPS) compared with placebo in adults with knee osteoarthritis (OA) pain. This Phase 3, randomized, double-blind, placebo-controlled study aims to evaluate changes in knee pain and function. The study will enroll approximately 466 participants who meet specific clinical and radiographic criteria for knee OA and have experienced pain despite prior treatments. Participants will be randomly assigned to receive either PPS at a dose of 2 mg/kg or placebo via subcutaneous injections twice weekly for 6 weeks. The study includes a 7-week screening period, followed by the 6-week treatment phase, and a 52-week follow-up period, totaling up to 64 weeks of participation. An interim analysis will be conducted after about half of the participants complete Day 112, with final analysis after all complete Day 404. Throughout the study, participants will attend visits twice weekly during treatment and every 4 to 6 weeks during follow-up. Researchers will assess knee pain using a daily pain rating scale and monitor changes from baseline up to Day 112. Safety and treatment effects will be evaluated through clinical exams, laboratory tests, and imaging as needed. Participants must adhere to stable non-pharmacologic treatments and limit use of certain medications during the trial.

This research investigates the effectiveness and safety of combining capivasertib with CDK4/6 inhibitors and fulvestrant in adults with hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) breast cancer that is locally advanced, inoperable, or metastatic. It includes a Phase Ib dose-finding portion to establish safe dosages for the triple combination, followed by a Phase III study comparing this combination to CDK4/6 inhibitors plus fulvestrant alone. The study focuses on patients who have not received prior endocrine therapy for advanced disease and aims to assess added benefit in a high-risk population. During Phase Ib, participants receive capivasertib orally twice daily for 4 days followed by 3 days off each week, combined with fulvestrant injections and one of the CDK4/6 inhibitors (palbociclib, ribociclib, or abemaciclib) at varying doses to find the recommended dose for Phase III. In Phase III, participants are randomized to receive capivasertib plus fulvestrant and a CDK4/6 inhibitor at the established dose or fulvestrant plus a CDK4/6 inhibitor alone, with dosing schedules maintained over 28-day cycles. Participants undergo regular monitoring including scans for tumor assessment, blood tests, and safety evaluations over extended periods—up to 47 months for progression-free survival assessment. Researchers track adverse events, serious side effects, and treatment tolerability throughout. Mandatory tumor and blood samples are collected for biomarker analysis. The study evaluates key outcomes such as dose-limiting toxicities, treatment-related adverse events, and progression-free survival, supporting long-term safety and effectiveness evaluation.

Researchers are evaluating KESONOTIDE12, a new hGIIA-vimentin inhibitor, in adults with advanced or metastatic solid cancers including prostate, breast, lung, ovarian, glioblastoma multiforme, pancreas, and skin cancers. This adaptive phase I/II trial aims primarily to assess the safety and tolerability of KESONOTIDE12 when given alone. The study also seeks to understand how the drug behaves in the body (pharmacokinetics). The phase I portion uses a dose escalation design to find the best dose, while phase II explores treatment effects in selected patient groups. Participants will receive KESONOTIDE12 orally every 21 days in cycles. Phase I includes four increasing dose levels: 10mg, 30mg, 60mg, and 120mg. In phase II, participants will get one of two doses recommended from phase I results, either alone or with standard treatments. Treatment continues until the disease worsens, side effects become unacceptable, consent is withdrawn, or other reasons for stopping occur. The study design allows changes, including stopping early for success or futility. During the study, participants will undergo regular assessments including scans (CT/MRI), lab tests, vital sign monitoring, ECGs, and performance status evaluations. Safety is closely tracked through adverse event monitoring, heart rate, blood pressure, lab values, and treatment tolerance over the first 21-day cycle. The study also evaluates pharmacokinetics and follows participants until disease progression or discontinuation. The trial plans to enroll about 20-32 participants in phase I and approximately 80 in phase II.

Researchers are evaluating the safety and effectiveness of a drug called HB-1 compared to placebo and two other medications in adults aged 18 to 65 years diagnosed with Panic Disorder. This phase 2, multicenter, randomized, double-blind, placebo-controlled trial aims to include approximately 240 to 600 participants, including those with or without certain co-existing conditions, to better understand treatment options for Panic Disorder. Participants will be randomly assigned to receive HB-1, telmisartan, verapamil, or a matched placebo, all provided as tablets. The treatment period lasts 12 weeks, after which a safety follow-up visit will occur one week after the last dose. Throughout the study, patients and researchers will not know which treatment the participants receive to ensure unbiased results. During the trial, participants will be monitored regularly for the number of unexpected panic attacks and any side effects that may arise, with assessments occurring weekly during treatment and at follow-up. Safety evaluations, including laboratory tests and questionnaires, will be conducted at specific intervals to track participants' health and treatment effects throughout the study duration.

Erectile dysfunction (ED) is a common condition in men, often associated with reduced quality of life and linked to health issues like depression, diabetes, and cardiovascular disease. Researchers are evaluating the long-term safety and effectiveness of the Rigicon Infla10ae Three-Piece Inflatable Penile Prosthesis to treat ED. This study follows patients who receive this prosthesis for up to three years after implantation to gather comprehensive safety and efficacy data. Participants receive the Rigicon Infla10ae device, a patient-activated inflatable penile prosthesis designed to help achieve and maintain an erection. The study includes several follow-up visits at 14 days, 6 weeks, 6 months, 12 months, 18 months, 24 months, and 36 months after the procedure. During these visits, participants are monitored according to study protocols and standard care for ED and related health conditions. Throughout the study, researchers assess safety by tracking adverse events related to the device or procedure over a 12-month period. Effectiveness is measured by an objective test of penile rigidity at 12 months. Participants complete follow-up visits and tests to monitor outcomes and device function. The total study duration includes up to three years of observation to ensure long-term safety and performance.

Researchers are conducting a Phase 1/2 randomized, observer-blinded, dose-escalation trial to evaluate the safety, tolerability, and immune response of an investigational herpes zoster vaccine called Z-1018 compared to the approved Shingrix vaccine. The study involves healthy adults aged 50 years and older, aiming to better understand how these vaccines perform in preventing shingles and related complications. In Part 1 of the trial, about 440 participants aged 50 to 69 years will be randomly assigned to one of ten groups receiving different doses of Z-1018 or to the Shingrix group. Part 2 will enroll approximately 324 participants aged 70 years or older to receive either the selected Z-1018 dose from Part 1 or Shingrix in a 1:1 ratio. Participants receive two vaccine doses, and Part 2 includes extended follow-up for four years after the initial 12-month post-vaccination period to assess long-term immune protection and incidence of shingles and postherpetic neuralgia. Participants will be monitored for local and systemic reactions up to seven days after each dose and adverse events for 28 days post-injection. Serious and medically attended adverse events will be tracked for up to 12 months after the last dose. Immune responses will be measured four weeks after the second dose by vaccine response and antibody levels. Study visits include medical evaluations, laboratory tests, and adherence assessments throughout the trial duration.

Researchers are evaluating the safety, tolerability, and initial effectiveness of AU-007, a monoclonal antibody that binds to IL-2 and inhibits IL-2Rb1 binding, in patients with advanced solid tumors, including unresectable locally advanced or metastatic cancers. This first-in-human, open-label, multicenter Phase 1/2 study includes patients who are ineligible for or have progressed on prior standard treatments. The study focuses on patients with cutaneous melanoma, non-small cell lung cancer (NSCLC), and other selected solid tumors. The study has multiple treatment arms: Arm A tests escalating doses of AU-007 every two weeks (Q2w) alone to find the recommended phase 2 dose (RP2D) or maximum tolerated dose (MTD). Arm B combines AU-007 Q2w with a single loading dose of aldesleukin. Arm C evaluates AU-007 and aldesleukin both given Q2w with escalating aldesleukin doses. Later parts of the study include expansion cohorts to assess AU-007 plus aldesleukin at RP2D in melanoma and NSCLC. Part 3 tests AU-007 plus aldesleukin with avelumab in NSCLC, and Part 4 evaluates this combination with nivolumab in cutaneous melanoma. Participants undergo tumor imaging (CT or MRI) and lab tests to confirm measurable disease and monitor safety. Safety and tolerability are evaluated throughout treatment and up to 28 days after the last dose. The study also measures the maximum tolerated dose and recommended phase 2 dose. Patients must have progressed on prior therapies and meet certain health criteria. Female participants of childbearing potential and male participants with partners of childbearing potential must follow contraception guidelines during and after treatment. Overall participation length depends on the treatment arm and response evaluations.