Albany

Researchers are evaluating the safety and effectiveness of a new medication called CX11 in adults with type 2 diabetes who have not achieved good blood sugar control despite taking a stable dose of metformin, with or without an SGLT2 inhibitor, for at least 90 days. This Phase 2 study is conducted at multiple medical centers and uses a randomized, double-blind, placebo-controlled design to compare different doses of CX11 against placebo over a 24-week treatment period. Participants will be randomly assigned to one of six groups, each receiving a different dose of CX11 tablets or matching placebo tablets taken orally once daily. The treatment phase lasts 24 weeks, followed by a 2-week safety follow-up period where researchers will monitor participants for any side effects or health changes after stopping the study medication. Throughout the study, participants will undergo assessments including blood tests to measure changes in glycosylated hemoglobin (HbA1c) from the start of the study to week 24. Other evaluations will monitor safety and health status. The total participation time is approximately 26 weeks, including treatment and follow-up. Researchers will also track adherence to medication and lifestyle instructions during this time.

Researchers are evaluating the effects of ALTO-207 on adults with treatment-resistant depression (TRD). This Phase 2 trial compares ALTO-207 against a placebo to measure changes in depressive symptoms in participants who have moderate to severe major depressive disorder and have not responded adequately to previous antidepressant treatments. The goal is to understand how well ALTO-207 works in improving depression symptoms in this group. Participants will receive either ALTO-207 twice daily or a matching placebo. This randomized, double-blind, placebo-controlled trial involves treatment over a period of up to 8 weeks, during which symptom changes will be closely monitored. The study focuses on adults aged 18 to 75 who are already on stable doses of one or two oral antidepressants. During the study, participants will be assessed for changes in their depression severity using the MADRS (Montgomery-Åsberg Depression Rating Scale) from baseline up to 8 weeks. Researchers will monitor safety and symptom changes throughout the treatment period. Participants’ adherence to the treatment and overall health will also be observed to gather comprehensive data on the study outcomes.

Researchers are establishing the Caris Biorepository to collect and store high-quality biological specimens along with clinical and demographic data. This resource aims to support research studies focused on advancing precision medicine and improving patient care, especially in areas related to cancer, early detection of cancer, and minimal residual disease. The biorepository is designed to securely share valuable biospecimen information and clinical outcomes to help develop targeted treatments and improve healthcare. The Caris Biorepository will gather specimens prospectively from multiple sources and maintain molecular integrity and clinical relevance of these samples. It will provide access to this information for researchers both within Caris Life Sciences and external collaborators such as government agencies, academic institutions, and industry partners. The project supports drug development, clinical research trials, publications, and healthcare policy development by bridging the gap between human specimens and associated clinical data. Participants in this research will provide biospecimens and clinical data, with the biorepository managing access and use of these materials over time. The study focuses on developing a high-quality collection of human samples and associated data for up to 35 years, supporting various research purposes. Outcomes include ensuring specimen integrity and releasing specimens for testing while maintaining detailed clinical information to facilitate future medical discoveries and improvements in patient outcomes.

Researchers are evaluating how to best recommend chemotherapy for patients with colon cancer after surgery by using the presence or absence of circulating tumor DNA (ctDNA) in the blood. This approach aims to identify microscopic residual tumor cells and may provide better risk prediction for cancer recurrence compared to traditional methods. The trial focuses on patients with Stage IIB, IIC, or III colon cancer who have undergone complete tumor removal. Participants will have their tumor tissue and blood tested centrally using the Signatera assay to determine ctDNA status. Patients without detectable ctDNA may avoid chemotherapy, while those with detectable ctDNA are considered at higher risk and will be randomly assigned to receive different chemotherapy regimens, including mFOLFOX6, CAPOX, or mFOLFIRINOX, given intravenously or orally over periods ranging from 3 to 6 months. The study includes initial screening, treatment, and possible second randomization for patients whose ctDNA status changes during monitoring. During the study, participants will undergo various assessments including blood tests, imaging scans, and performance evaluations to monitor their health and response to therapy. Researchers will track the time to ctDNA positivity and disease-free survival for up to 3 and 5 years, respectively. Safety and treatment effects will be closely observed throughout the study duration, ensuring thorough follow-up and monitoring for all participants.

Researchers are conducting a two-part, phase 2b/3 study to evaluate CSL300 (Clazakizumab) in adults with end stage kidney disease (ESKD) undergoing dialysis who have systemic inflammation and either atherosclerotic cardiovascular disease (ASCVD) or diabetes. The study aims to determine the best dose of CSL300 and assess its effects on cardiovascular outcomes and safety in this population. This multicenter, randomized, double-blind, placebo-controlled trial targets patients with elevated inflammation markers and significant health risks due to their conditions. In the first part (phase 2b), the study focuses on finding the appropriate dose of CSL300 compared to placebo. CSL300 is given through intravenous (IV) administration. The second part (phase 3) evaluates the impact of CSL300 on cardiovascular events such as heart attack or cardiovascular death over approximately 5 years, continuing to compare CSL300 to placebo for safety and efficacy. The placebo matches CSL300's excipient content but lacks the active drug. Participants will undergo baseline and regular assessments for inflammation markers like high-sensitivity C-reactive protein (hs-CRP) up to 12 weeks in phase 2b, and long-term monitoring for cardiovascular outcomes in phase 3. The study involves ongoing safety evaluations and efficacy measurements during the entire follow-up period. This comprehensive approach helps researchers understand how CSL300 affects inflammation and cardiovascular health in patients with ESKD on dialysis.

Researchers are evaluating different treatment combinations for younger patients with intermediate risk acute myeloid leukemia (AML) in this phase II MyeloMATCH trial. The study compares three regimens: cytarabine with daunorubicin, cytarabine with daunorubicin plus venetoclax, and venetoclax with azacitidine. The goal is to see if adding venetoclax improves the elimination of AML cells by at least 20% compared to the standard cytarabine and daunorubicin treatment. Participants are randomly assigned to one of three treatment groups. One group receives daunorubicin intravenously on days 2-4, continuous intravenous cytarabine on days 2-8, and oral venetoclax daily on days 1-11, with possible reinduction cycles. Another group receives azacitidine intravenously or subcutaneously on days 1-7 or days 1-5 and 8-9, plus oral venetoclax daily for 28 days, repeated for 2 cycles. The last group receives daunorubicin intravenously on days 1-3 and continuous intravenous cytarabine on days 1-7, with possible reinduction. Treatments continue unless disease progresses or unacceptable side effects occur. During the study, participants undergo bone marrow aspirations and blood sample collections to monitor response. Follow-up visits occur 4 weeks after treatment, then every 3 months for the first year, every 6 months in the second year, and yearly afterward. Researchers measure how well the treatments eliminate measurable residual disease and assess remission rates, side effects, survival outcomes, and treatment responses based on genetic features.

Researchers are evaluating different telephone-based symptom monitoring approaches to reduce symptom burden and psychological distress, including depression and anxiety, in people undergoing oral anti-cancer treatment. The study compares interactive voice response (IVR) symptom monitoring alone to automated telephone symptom management (ATSM) combined with telephone interpersonal counseling (TIPC). Symptoms often cause treatment interruptions and unplanned healthcare use, and managing these symptoms is especially challenging in community oncology settings. The study aims to learn which methods best help patients manage symptoms and improve outcomes during cancer treatment. Participants are assigned to one of two groups. In the first group, patients receive weekly IVR symptom monitoring calls for 12 weeks, with their symptom reports sent to their healthcare providers. In the second group, patients receive a Symptom Management and Survivorship handbook along with the IVR calls. Those reporting anxiety, discouragement, or sadness for two consecutive weeks early in the study also receive up to 8 weeks of telephone counseling (TIPC) focused on psychological distress and social support. After the 12-week intervention, patients are followed up for an additional 5 weeks, while healthcare practice personnel are assessed at study start and at 12 and 25 months. During the study, patients complete weekly symptom assessments via phone calls lasting 15 to 30 minutes depending on their group. Researchers collect data on symptom severity using a toxicity index, healthcare use, and psychological symptoms over the first 12 weeks and during follow-up. The study also evaluates how feasible and acceptable the interventions are within community oncology practices and estimates the costs and potential savings related to symptom management. Patient-reported financial burden and the impact of concurrent cancer treatments are also explored.

Researchers are studying the effectiveness and safety of KAI-9531, a drug given as a once-weekly subcutaneous injection, in adults living with obesity who do not have diabetes. The study aims to show that KAI-9531 leads to greater weight loss compared to semaglutide, another injection given weekly, and a placebo. This is a Phase 3 randomized, partially-blinded trial that compares these treatments in people with a body mass index (BMI) of 35 kg/m² or higher who have tried and failed to lose weight through diet and exercise within the last six months. Participants will be assigned to receive either KAI-9531, semaglutide, or a placebo, all administered by subcutaneous injection once a week. The study will monitor changes in body weight over a period of 76 weeks to assess which treatment is more effective. The trial design includes active and placebo-controlled groups to carefully evaluate the impact of KAI-9531 on weight management. During the study, participants will undergo assessments to measure their body weight and other health parameters at baseline and throughout the 76-week period. The main outcome being measured is the percent change in body weight from the start of the study to week 76. Safety and tolerability of the treatments will also be monitored. Participants will be followed closely to ensure adherence and to track any side effects or changes in health status throughout the study duration.

This research aims to evaluate how the Safe Dates for Young Parents (SDYP) program affects sexual and reproductive health behaviors, quality of life, and attitudes about intimate partner relationships in adolescents and young adults assigned female sex at birth who are pregnant or parenting. It focuses on whether the SDYP intervention impacts sexual behaviors, helps prevent or reduce intimate partner violence, and changes beliefs about healthy relationships during the study period. Participants assigned to the SDYP intervention will attend ten group sessions, each lasting 50 minutes. These sessions include interactive discussions, role-plays, games, brainstorming, analysis of scenarios, a poster contest, and a theatrical play. Researchers will compare outcomes between participants who receive the SDYP intervention and those in the control group who do not. During the study, participants will complete three interviews over one year to assess their sexual behaviors, attitudes, and experiences with intimate partner violence. The main outcome measured is condomless vaginal or anal sex at three and twelve months. The study will monitor changes in behaviors and beliefs related to sexual and reproductive health and relationship quality throughout the year.

Researchers are evaluating the safety, tolerability, how the body processes the drug (pharmacokinetics), how the drug affects the body (pharmacodynamics), and possible effectiveness of an investigational drug called ENV-294 in adults with moderate to severe asthma. These participants are already receiving background treatment with inhaled corticosteroids and long-acting beta2-agonists. The study is a Phase 2 trial designed to better understand ENV-294's impact on asthma while participants continue their current asthma therapies. Participants will be randomly assigned to receive either oral ENV-294 tablets or matching placebo tablets once daily for 12 weeks. Before starting treatment, there is a screening period lasting up to 28 days to confirm eligibility. The study maintains a double-blind design, meaning neither the participants nor the researchers know who receives the active drug or placebo during the 12-week treatment period. During the study, participants will attend visits and undergo assessments to monitor safety and side effects. Blood samples will be taken to measure drug levels and study pharmacokinetics. Researchers will also evaluate asthma control and lung function, focusing on the incidence and severity of adverse events from the first dose through approximately 16 weeks. The total participation duration includes screening and treatment with close monitoring throughout.