Huntersville

Researchers are investigating the feasibility of collecting and expanding T lymphocytes from both cancer patients and healthy volunteers. The study aims to select specific immune cells marked by PD-1 and CTLA4 from the blood and assess their ability to kill tumor cells outside the body. This observational study includes adults with any stage of solid tumors, healthy volunteers, and individuals with COVID-19, with special provisions for pediatric participants aged 5 to 17 years. Participants are divided into three groups cancer patients receiving routine care, healthy volunteers who help optimize study procedures, and COVID-19 patients whose participation may be limited based on their condition. Adults and pediatric participants undergo blood and other minimally invasive biospecimen collections, including leukapheresis for eligible adults, to obtain immune and tumor cells. The study supports quality control, assay development, and device validation across cohorts. During the study, participants provide biospecimens such as blood, saliva, urine, and swabs. Researchers will analyze these samples to evaluate immune cell function and develop an ex-vivo device platform for culture, immune testing, and biobanking. The study collects clinical information and laboratory test results, including infection status and organ function markers. Participation requires informed consent and may include repeated sampling over time to support ongoing research efforts.

Researchers are conducting a long-term extension study to evaluate the safety, tolerability, and effectiveness of ORX750 in adults aged 18 to 65 years who have narcolepsy type 1, narcolepsy type 2, or idiopathic hypersomnia. This study follows participants who completed a previous ORX750 clinical trial and focuses on providing ongoing information about the treatment over an extended period. Participants will receive oral ORX750 in an open-label format, grouped by their specific diagnosis narcolepsy type 1, narcolepsy type 2, or idiopathic hypersomnia. The study does not involve randomization or blinding, allowing all participants to know they are receiving the study drug. The treatment and monitoring periods include assessments up to about 70 days for safety and roughly 63 days for measures of drug concentration and wakefulness. During the study, participants will undergo frequent evaluations including monitoring for adverse events, laboratory tests, vital signs, ECGs, and assessments for suicidal thoughts or behaviors. They will also complete tests measuring wakefulness and sleepiness levels. This ongoing observation aims to ensure the treatments safety and to understand its effects over time, with participant involvement lasting through the entire study period.

Researchers are evaluating the long-term safety, tolerability, and lasting effects of ALKS 2680 tablets in adults with Narcolepsy Type 1, Narcolepsy Type 2, or Idiopathic Hypersomnia. This study is an open-label extension designed to continue monitoring participants who completed earlier ALKS 2680 parent studies, focusing on treatment durability and adverse events over an extended period. Participants receive ALKS 2680 oral tablets in doses ranging from 4 mg to 18 mg once daily. The study includes groups with Narcolepsy Type 1, Narcolepsy Type 2, and Idiopathic Hypersomnia. Treatment effects and safety are observed for up to 100 weeks, with dosing adjusted as needed. The study follows a non-randomized, open-label design without blinding. During the study, participants undergo regular assessments including monitoring of treatment-emergent adverse events, measurement of sleep latency using the Maintenance of Wakefulness Test, and evaluation of daytime sleepiness via the Epworth Sleepiness Scale. The total participation duration extends up to approximately 100 weeks, with safety, tolerability, and treatment effects closely tracked throughout this period.

Researchers are studying JMT108, a bispecific antibody drug, in adults with locally advanced or metastatic solid tumors who have not responded to or cannot tolerate standard treatments. The study aims to assess the safety, tolerability, and best dosing schedule of JMT108, as well as its effectiveness, how the body processes the drug, immune response to the drug, and preliminary anti-tumor activity. This Phase 1 trial includes dose escalation and cohort expansion phases to better understand the treatments impact. The study involves two parts Phase 1a dose escalation and Phase 1b cohort expansion. In the dose escalation phase, participants receive increasing doses of JMT108 by intravenous injection every two weeks, starting from 0.1 mgkg up to 2 mgkg, to find the maximum tolerated dose. Following evaluation, the study expands to include participants with various tumor types such as lung, colorectal, liver, gastric, melanoma, and other advanced solid tumors. The dose and schedule for this expansion phase are determined based on earlier results. Participants will provide consent, undergo screening to confirm eligibility, and attend regular study visits for treatment and monitoring. Researchers will assess tumor response using specific criteria and monitor for side effects, immune response, and how the drug is processed in the body. After treatment ends, participants will be followed every three months for up to two years to track disease progression and long-term outcomes. The entire participation duration varies depending on treatment response and study phase.

Researchers are investigating CRB-701, an antibody-drug conjugate targeting nectin-4, in adult patients with advanced solid tumors that express this protein. This three-part, open-label Phase 12 trial aims to determine a safe and effective dose of CRB-701 and to understand which cancers might respond to this treatment. The study explores safety, pharmacokinetics, and efficacy to guide future cancer therapies. Participants will receive CRB-701 through intravenous infusion over 30 minutes. The trial includes several dosing groups that range from dose escalation to dose optimization, sometimes combined with an anti-PD-1 drug. Part A focuses on escalating doses to find the maximum tolerated dose, Part B tests dose levels alone or with anti-PD-1 to optimize treatment, and Part C explores the recommended dose in multiple tumor cohorts. During the study, participants will attend clinic visits for infusions and undergo blood tests, CT or MRI scans, and other assessments to monitor tumor response and safety. Researchers will measure the safety, tolerability, and objective response rate to evaluate the treatments effect on tumors over periods ranging from 21 days to up to 6 months. The total study duration and monitoring will capture data on efficacy and side effects to support further research.

Researchers are evaluating TER-2013 in a Phase 12 open-label study involving patients with advanced solid tumors that have specific alterations in the AKTPI3KPTEN pathway. This first-in-human trial aims to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor effects of TER-2013 both alone and combined with fulvestrant. The study is conducted across multiple centers and includes patients with cancers such as breast, endometrial, ovarian, lung squamous cell, head and neck squamous cell, esophageal squamous cell, cervical cancer, and other solid tumors. The trial has two main parts Dose Escalation and Dose Expansion. Participants receive TER-2013 oral capsules either by itself or alongside fulvestrant, an injection given intramuscularly at 500 mg. The Dose Escalation part determines the maximum tolerated dose and assesses safety, while the Dose Expansion evaluates preliminary clinical activity at the recommended dose. Treatment schedules include administration of TER-2013 with recommended doses of fulvestrant where applicable. Participants undergo regular evaluations for safety and treatment effects up to two years. Researchers monitor dose-limiting toxicities within 28 days, treatment-related adverse events, objective response rates, and duration of response according to RECIST criteria. Pharmacokinetic parameters such as drug concentration over time and pharmacodynamic markers in tissue and blood are also assessed. The study involves ongoing safety monitoring and follows participants to gather comprehensive data on TER-2013s effects.

Researchers are evaluating the efficacy and safety of HBS-301 in adults aged 18 years and older who have idiopathic hypersomnia IH, a condition marked by excessive daytime sleepiness EDS. This Phase 3, multicenter, randomized, double-blind, placebo-controlled study aims to better understand how HBS-301 affects symptoms of IH including sleep inertia, fatigue, and cognitive complaints. Participants will be assigned to receive either HBS-301 tablets or matching placebo tablets once daily in the morning upon waking during an 8-week double-blind treatment period. Following this, there is an optional one-year open-label extension where all participants may receive HBS-301. The study begins with a screeningbaseline period lasting up to 28 days and concludes with 30 days of safety follow-up after treatment. During the trial, participants will undergo various assessments including the Epworth Sleepiness Scale to measure daytime sleepiness, the Idiopathic Hypersomnia Severity Scale, Sleep Inertia Questionnaire, and other patient-reported outcome measures. Researchers will monitor changes in fatigue, cognitive function, quality of life, work productivity, and side effects throughout the study and extension period. Total participation may last up to about 16 months including safety follow-up.

Researchers are conducting a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of HBS-301 in adults aged 18 years and older with narcolepsy. The study focuses on treating excessive daytime sleepiness EDS, cataplexy, sleepinesswakefulness, and fatigue in participants diagnosed with narcolepsy. Approximately 258 participants will be included in this trial. Participants will be randomly assigned to receive either HBS-301 tablets or matching placebo tablets once daily in the morning upon waking. The study includes a ScreeningBaseline period lasting up to 28 days, followed by an 8-week Double-blind Treatment period. After this, participants may choose to enter a 1-year Open-label Extension period where they will receive HBS-301. Finally, a 30-day safety follow-up will monitor participants after treatment ends. Throughout the study, participants will undergo various assessments including evaluations of daytime sleepiness using the Epworth Sleepiness Scale, cataplexy frequency, wakefulness through the Maintenance of Wakefulness Test, fatigue levels, cognitive complaints, quality of life, and work productivity. Safety will be monitored by tracking adverse events and pharmacokinetic measurements. The total study participation may last up to approximately 16 months including all phases.

Researchers are evaluating the SureSmile clear aligner medical device in a three-armed, multicenter clinical study focused on patients with malocclusion. The primary goal is to confirm the safety and measure the accuracy of different tooth movements using three distinct trimline designs Scalloped, Straight, and Straight Extended. This study aims to compare these designs to better understand their performance during clear aligner therapy. Participants will receive one of three SureSmile clear aligner designs, each customized to fit different mouth shapes and sizes. The study groups include the scalloped trimline design, the straight trimline design, and the straight extended trimline design with a 2 mm extension. All other treatment protocols and materials are consistent across groups. The treatment period typically lasts between 6 to 18 months, followed by a refinement period averaging 8 to 12 weeks. During the study, participants will be monitored regularly for tooth movement accuracy, comfort and pain levels every 8 weeks, and any adverse events or device issues from the start of treatment until the retainer delivery visit, which occurs about 18 months after treatment begins. Researchers will assess outcomes based on the planned treatment and gather data on refinement rates and safety. Participant involvement includes follow-up visits for assessments throughout the treatment and refinement periods.

Researchers are evaluating the safety, tolerability, pharmacokinetics, and anti-tumor activity of HCB101, an intravenous Fc-fusion protein targeting the SIRP-CD47 pathway, in adults aged 18 years and older with advanced solid tumors or relapsed and refractory non-Hodgkin lymphoma. This Phase 1, open-label, multi-center study aims to identify the maximum tolerated dose and monitor any side effects in participants who have failed standard therapies or are considered unsuitable for such treatments. Participants will receive HCB101 through intravenous injection at gradually increasing doses, starting from 0.08 mgkg up to 36 mgkg sequentially. Treatment will continue until unacceptable adverse events, disease progression, withdrawal, loss to follow-up, death, or study termination. The study involves dose escalation to determine the optimal dose level for further research. During the study, participants will undergo regular safety monitoring, blood sampling for pharmacokinetics, and tumor assessments using established criteria. Researchers will measure adverse event rates, immune responses, tumor response rates, and drug concentration over a 12-month period. The study includes comprehensive evaluation of anti-tumor effects and safety, with participants followed until study completion or withdrawal.