Houston

Researchers are evaluating the safety, tolerability, and effectiveness of CYB003, a Deuterated Psilocin Analog, compared to a placebo when added to current antidepressant treatment in adults with moderate to severe Major Depressive Disorder (MDD). This Phase III trial focuses on participants aged 18 to 85 years who have had inadequate response to a stable antidepressant dose, aiming to better understand how CYB003 might improve depressive symptoms. Participants receive oral doses of CYB003 or matching placebo along with manualized psychological support provided by trained facilitators. The treatment period includes multiple dosing sessions with monitoring and assessments throughout. Placebo is used as a comparator to evaluate the combined safety and efficacy of CYB003 in this population. During the study, participants undergo evaluations using the Montgomery-Åsberg Depression Rating Scale (MADRS) at several time points, including screening, baseline, and multiple days up to the end of treatment at Day 42. Researchers monitor symptoms, side effects, and overall safety. Participants provide informed consent and are assessed regularly to track changes in depression severity and any adverse events over the course of the study.

Researchers are investigating the drug bezuclastinib in an open-label, two-part Phase 2 study for patients with Advanced Systemic Mastocytosis (AdvSM), including Aggressive Systemic Mastocytosis (ASM), Systemic Mastocytosis with an Associated Hematologic Neoplasm (SM-AHN), and Mast Cell Leukemia (MCL). The study aims to evaluate the safety, effectiveness, and how the drug behaves in the body for these serious conditions. Bezuclastinib is given orally as tablets taken continuously in 28-day cycles. The study has two parts: Part I focuses on identifying safe and tolerable doses of bezuclastinib over 18 months, while Part II evaluates its effectiveness by measuring the objective response rate and confirming the relationship between drug exposure and response during another 18-month period. Participants will undergo assessments including clinical evaluations, laboratory tests, and monitoring of their disease status to determine treatment effects and safety. Researchers will track the drug's impact on the disease and patient health throughout the study, which involves continuous treatment and follow-up over the specified time frames.

Researchers are evaluating the safety and effectiveness of elenestinib (BLU-263) combined with symptom-directed therapy (SDT) compared to placebo plus SDT in people with indolent systemic mastocytosis (ISM) whose symptoms are not well controlled by SDT alone. This Phase 2/3 randomized, double-blind, placebo-controlled study includes participants with ISM and smoldering systemic mastocytosis, and also involves groups for pharmacokinetic studies and participants who previously received a selective KIT inhibitor. The study is divided into multiple parts. Parts 1 and 2 enroll participants with ISM who will receive either elenestinib oral tablets or placebo alongside their symptom-directed therapy. Participants from Part 2 may continue into Part 3, which is an open-label extension where all receive elenestinib. Part K enrolls participants with ISM who have prior experience with selective KIT inhibitors. The study tracks treatment effects and safety over time. Participants will be monitored for up to 5 years, with assessments including the number of treatment-emergent adverse events, changes in symptom scores measured by the ISM-Symptom in Assessment Form, and overall safety monitoring. Evaluations occur at baseline, 13 weeks, 49 weeks, and throughout the long-term follow-up. The study also includes detailed tracking of symptom control and adverse events to evaluate the impact of treatment on participants' health and quality of life.

Researchers are evaluating (Z)-endoxifen as a potential treatment for premenopausal women with estrogen receptor-positive (ER+) and HER2-negative breast cancer. This phase 2 open-label study includes two parts: a pharmacokinetic (PK) phase to understand how the body processes the drug and a treatment phase to assess the drug's effects on tumor growth. The study aims to see if (Z)-endoxifen can slow or stop tumor growth by measuring changes in a biomarker called Ki-67. Participants are premenopausal women who meet specific cancer and health criteria. Participants in the PK part will take (Z)-endoxifen capsules daily at varying doses (20 mg, 40 mg, or 80 mg). Some will also receive a monthly injection of goserelin, a drug that temporarily stops estrogen production in the ovaries. The treatment cohort will receive both (Z)-endoxifen and goserelin. Tumor tissue samples will be collected by breast biopsy after about 4 weeks to assess the Ki-67 biomarker. Participants showing tumor response may continue treatment for up to 24 weeks or until they undergo surgery. Throughout the study, participants will have blood draws to measure drug levels and tumor markers, breast biopsies, imaging scans, and safety assessments. The main outcomes include measuring (Z)-endoxifen levels after 4 weeks, the rate of Ki-67 reduction, and tumor response after 24 weeks. Study participation lasts up to 6 months, including treatment, surgery, and a follow-up visit one month after surgery.

Researchers are evaluating if 18F-FAraG PET scans can detect tumors and predict treatment response in people with esophageal cancer. This Phase 1 study aims to assess the ability of 18F-FAraG PET imaging to find tumors and predict complete response after chemoradiation. The study also looks at how 18F-FAraG PET relates to clinical features, single-cell RNA sequencing data, tissue and blood biomarkers, and compares it to standard 18FDG-PET scans. Participants will receive the investigational drug ArabinoFuranosylGuanine [18F]F-AraG given intravenously. The study involves PET/CT scans before and after chemoradiation therapy. Researchers will use these scans alongside tissue and blood tests to evaluate treatment effects and disease outcomes. The study also monitors changes in PET scan measurements over time and compares them to standard imaging methods. During the study, participants will complete imaging scans, provide tissue and blood samples, and undergo clinical assessments. Researchers will track safety and adverse events throughout the study, which lasts about one year. Outcomes measured include the accuracy of tumor detection, prediction of treatment response, survival, and disease recurrence. Participants’ health will be carefully monitored to assess the effects and safety of the investigational imaging agent.

Researchers are evaluating the use of the fluorine F 18 L-glutamate derivative BAY94-9392 (18F-FSPG) in PET imaging to help diagnose liver cancer and assess how far it has spread before patients undergo surgery or liver transplant. This phase 1 trial focuses on patients with suspected hepatocellular carcinoma (HCC) or other liver tumors scheduled for liver resection or orthotopic liver transplant (OLT). The study compares 18F-FSPG PET/CT with other imaging methods like standard MRI, 11C-acetate PET/CT, and 18F-FDG PET/CT, and explores its uptake in benign and malignant liver lesions. Participants undergo PET scans using 18F-FSPG and either 11C-acetate or 18F-FDG within 4 weeks before surgery or OLT. The procedures include PET imaging with these radiotracers and correlative laboratory biomarker analysis. The study compares imaging results with pathology findings after surgery, assessing tumor characteristics and metabolic activity. These imaging tests aim to evaluate and compare how well 18F-FSPG PET detects liver cancer and differentiates between tumor types. During the study, researchers measure uptake values from PET scans, number of lesions, and diagnostic accuracy compared to pathology results over up to 4 years. Participants complete conventional imaging and staging with MRI or CT before PET imaging. The study tracks tumor grade, immunohistochemistry, and pharmacokinetics of the radiotracers. Safety and diagnostic measures are monitored throughout, with evaluations done within 4 weeks before surgery and continued through study completion.

Researchers are evaluating the use of 18F-mFBG, a positron-emitting radiopharmaceutical, as an imaging agent to measure the impact of neurodegenerative diseases on the heart's sympathetic nervous system. This Phase 2 study focuses on subjects with Lewy body diseases such as Parkinson's disease and Lewy body dementia, comparing their heart imaging results to those of individuals with other neurological diseases and historical healthy controls. The goal is to achieve reliable, quantitative imaging of myocardial sympathetic innervation using this agent, which may provide improved accuracy over previous imaging methods. Participants receive an intravenous injection of 222-370 MBq (6-10 mCi) of 18F-mFBG followed by whole-body PET imaging. The study includes two groups: one with Lewy body disease diagnosed at least six months before enrollment, and another with other neurological or neurodegenerative diseases. The imaging is performed once after confirming clinical stability for at least 30 days prior to the procedure. During the study, participants undergo PET imaging to assess the extent of reduced myocardial uptake of 18F-mFBG, with the primary outcome measured at six months. Researchers will monitor heart function and compare imaging data to evaluate sympathetic nervous system involvement in Lewy body diseases. Safety and stability are assessed throughout, and participants must comply with study procedures and provide informed consent.

Researchers are evaluating the safety, effectiveness, and participant satisfaction of a 2,910 nm mid-infrared Fiber Laser (UltraClear, Acclaro Medical) for treating advanced perioral lines and wrinkles. This study focuses on skin rejuvenation through both superficial epidermis ablation and deeper dermal ablative and coagulative effects. The target population includes adults aged 50 to 80 with photodamaged skin and significant wrinkles around the mouth. Participants will undergo up to two laser resurfacing treatments spaced 6 to 8 weeks apart using the UltraClear laser device. These treatments aim to improve the appearance of perioral lines and wrinkles by targeting both the surface and deeper layers of the skin. After treatment, participants will return for follow-up visits at 1 month and 3 months to assess the laser's effectiveness and safety. During the study, participants will be evaluated using multiple scales, including the Fitzpatrick Wrinkling and Degree of Elastosis Scale, the Physician Global Aesthetic Improvement Scale, and assessments by blinded Independent Photographic Reviewers. Researchers will monitor safety, overall aesthetic improvement, and participant satisfaction from enrollment through the final follow-up visit three months after the last treatment.

Researchers are evaluating whether advanced radiation treatment techniques called stereotactic body radiation therapy (SBRT) can safely deliver a strong dose of radiation to tumors in people with head and neck squamous cell carcinoma (HN SCC) more quickly than traditional radiation methods. This phase II trial aims to compare the effects of SBRT versus traditional radiation on local progression-free survival, pain relief, symptom burden, toxicity, local control, progression-free survival, and overall survival for patients who are not eligible for curative treatment. Participants in this study will be randomly assigned to receive either SBRT or traditional palliative radiation therapy. The exact radiation schedule will be determined with the study doctor. Both treatment approaches involve radiation targeted to the tumor in the head and neck area, which includes sites like the oral cavity, oropharynx, nasopharynx, hypopharynx, larynx, salivary glands, and certain skin areas. Patients may have previously received radiation, surgery, or systemic therapy unless further radiation is not appropriate. During the study, participants will complete symptom questionnaires using the M. D. Anderson Symptom Inventory for Head & Neck (MDASI-HN) for about one year. Before treatment, they will undergo history and physical exams, imaging scans, pain assessments, and quality of life evaluations. Researchers will monitor symptoms, treatment side effects, and disease progression throughout the study to assess safety and effectiveness.

Researchers are investigating a treatment for patients with metastatic colorectal cancer who have already tried two previous therapies. This phase II trial aims to compare the effectiveness and safety of a combination of 5FU/LV and regorafenib against another treatment involving trifluridine-tipiracil plus bevacizumab. The goal is to determine if the 5FU/LV with regorafenib is not worse than the other treatment in this third-line setting. Participants will be randomly assigned in a 2:1 ratio to one of two treatment groups. The first group receives 5FU/LV through intravenous infusion every two weeks, combined with regorafenib taken orally daily with dose increases over a 3-week period followed by 1 week off, up to 12 cycles or until disease progression. The second group takes trifluridine-tipiracil orally twice daily on specific days in a 28-day cycle, along with intravenous bevacizumab on days 1 and 15, continuing up to 12 cycles or until the cancer worsens or side effects become unacceptable. Throughout the study, participants will be monitored from the start of treatment until disease progression, unacceptable side effects, or withdrawal, for up to 18 months. Researchers will assess treatment effectiveness and safety during this time. Patients' health will be evaluated regularly to observe how well the treatments control the cancer and to track any adverse effects experienced.