Hormone Therapy

Researchers are evaluating 177Lu-BetaBart, a 177Lu-labeled anti-B7-H3 monoclonal antibody, in patients with various relapsed or refractory solid tumors that are locally advanced, inoperable, or metastatic. This Phase 12a study aims to understand the safety, tolerability, how the drug moves through and affects the body, and early signs of anti-tumor activity. Eligible participants include adults 18 and older with cancers such as castration-resistant prostate cancer, colorectal cancer, lung cancers, head and neck cancer, ovarian, cervical, endometrial, triple negative breast cancer, and esophageal squamous cell carcinoma who have shown disease progression after recent treatments. The study has two main parts a Phase 1 dose escalation phase to find the maximum tolerated or recommended dose using a Bayesian design, and a Phase 2a dose expansion phase at that recommended dose to confirm safety and observe preliminary anti-tumor effects. Participants receive 177Lu-BetaBart through intravenous infusions every six weeks. Each phase includes a screening period, treatment and imaging period, and a safety and long-term follow-up period to closely monitor outcomes and side effects. During the study, participants undergo assessments including imaging for disease evaluation, laboratory tests for organ function and drug effects, and monitoring of side effects for up to 30 weeks. Key outcomes include determining the suitable dose for future studies, tracking adverse events, and measuring anti-tumor activity through objective response rates and biochemical responses in prostate cancer. Pharmacokinetics, radiation dosimetry, and biokinetics of the drug are also measured at specified time points. Safety and tolerability are evaluated continuously, with follow-up to monitor long-term effects and overall health.

Researchers are studying men with metastatic castration-resistant prostate cancer mCRPC to understand how different PETCT scans can predict outcomes during radioligand therapy with 177Lu-PSMA-617. This is an exploratory, prospective study conducted at a single center, focusing on imaging tumor heterogeneity to help assess therapy effects and patient response. The study is designed specifically for Veterans undergoing this treatment. Participants will receive several types of PETCT scans at different times before starting LuPSMA radioligand therapy RLT, and then after the 2nd, 4th, and 6th treatment cycles. These scans include 18F-Fluciclovine PETCT Axumin, 18F-DCFPyL PETCT, and 18F-FDG PETCT. The 18F-Fluciclovine scans will be performed within seven days of the PSMA PET scans to compare imaging results at each time point. During the study, detailed imaging measures such as lesion uptake and tumor volume will be collected and analyzed over time. Patients will be followed at the institution to correlate these imaging results with clinical outcomes. The main outcome measured is the impact of 18F-Fluciclovine PETCT on predicting outcomes of the 177Lu-PSMA-617 therapy from enrollment through 34 weeks of treatment.

Researchers are evaluating a new imaging method called 4FMFES-PET combined with FDG-PET to improve diagnosis and management of advanced estrogen receptor-positive ER breast cancer. ER status is a key factor in guiding treatment choices, but tumors can vary in ER expression over time and across sites. This study aims to assess the full potential of 4FMFES-PET, which has shown better image quality and tumor detection than earlier tracers, in combination with FDG-PET for whole-body, non-invasive ER status evaluation in advanced breast cancer patients. Participants with advanced ER breast cancer will undergo 4FMFES-PET imaging at the start, then again at 6 and 18 months, within 4 weeks of medically prescribed FDG-PET scans. The 4FMFES tracer is given intravenously followed by PET imaging. The study will compare and complement these PET scans with conventional imaging and correlate imaging results with pathology from biopsies and with clinical outcomes like treatment response and progression-free survival. During the study, participants will have multiple PET scans to monitor ER expression and tumor activity over time. Researchers will collect pathological data and track outcomes such as time to recurrence and treatment effects. The main measurements include uptake of 4FMFES on PET scans correlated with tissue markers and clinical progress over 18 to 36 months. This approach aims to better identify patient groups who may benefit from this imaging method to guide their care.

Researchers are evaluating a probiotic called WBF-038 in patients with early-stage hormone receptor-positive breast cancer who are beginning treatment with aromatase inhibitors. Aromatase inhibitors reduce estrogen production to help prevent cancer growth but can negatively impact bone health, weight, blood sugar, and waist size. This Phase II trial aims to see if WBF-038 can help prevent bone loss and improve metabolic health during this treatment. Participants receive WBF-038 by mouth once daily for 365 days, starting three months after beginning aromatase inhibitor therapy, unless disease progression or unacceptable side effects occur. During the study, patients undergo blood sample collections and bone mineral density tests at screening and various points throughout the trial. After completing the year of probiotic treatment, participants are followed up for 90 days. Throughout the study, researchers measure changes in bone turnover markers, bone mineral density in the lumbar spine and hips, blood sugar levels, weight, waist circumference, and inflammatory markers. Patient-reported symptoms related to aromatase inhibitor treatment are also assessed. Safety and fracture risk are monitored by tracking adverse events. The total participation is approximately 18 months from baseline to final follow-up.

Researchers are evaluating the safety and effectiveness of two drugs, 64Cu-SAR-bisPSMA and 67Cu-SAR-bisPSMA, in men with prostate cancer that has spread and no longer responds to hormone-lowering treatments. This study focuses on cancers that express a protein called PSMA and aims to find safe and effective dosing while monitoring how the drugs behave in the body. Participants will go through different study phases. In the initial dosimetry phase, a single dose of 200 MBq of 64Cu-SAR-bisPSMA is given. Later phases involve receiving multiple doses of 64Cu-SAR-bisPSMA or 67Cu-SAR-bisPSMA, with doses and number of administrations varying by phase and participant group. The dose escalation phase tests increasing doses of 67Cu-SAR-bisPSMA, followed by a cohort expansion phase with up to six doses of the recommended 67Cu-SAR-bisPSMA dose. During the study, participants will undergo PETCT scans to track drug distribution and dosimetry within 48 hours of dosing. Researchers will measure prostate-specific antigen PSA levels and radiographic responses over up to five years to evaluate treatment effects. Safety will be monitored through assessments of vital signs, ECGs, laboratory tests, and recording any adverse events. The total study duration can extend up to five years for long-term follow-up.

This research investigates treatments for metastatic castration-resistant prostate cancer mCRPC focusing on a drug called ifinatamab deruxtecan I-DXd. The study aims to assess the safety, how well participants tolerate the treatments, and appropriate dosing levels of I-DXd alone or combined with other therapies. Researchers will also monitor participants prostate specific antigen PSA levels during treatment to understand its effects. Participants are assigned to one of several treatment groups. One group receives docetaxel every three weeks for up to 10 cycles. Other groups receive I-DXd alone or combined with either opevesostat or androgen receptor pathway inhibitors such as abiraterone acetate or enzalutamide. I-DXd is given every three weeks until unacceptable side effects, disease progression, death, or withdrawal, while the other drugs continue until specific discontinuation criteria are met. Premedication is required before each I-DXd dose to prevent nausea and vomiting. Throughout the study, participants undergo various assessments including monitoring of dose-limiting toxicities, adverse events, and PSA response rates. Researchers also track objective response rates, progression-free survival, overall survival, and other clinical outcomes over up to approximately 54 months. The study involves regular evaluations to assess safety and treatment effects until study completion.

Researchers are studying a new treatment approach for patients with surgically removable head and neck squamous cell carcinoma HNSCC, a common and serious type of cancer in the head and neck region. The study evaluates the safety and tolerability of combining immune-targeted therapy with a lysogenic herpes simplex virus HSV as a neoadjuvant treatment to reduce tumor size before surgery. This innovative combination aims to improve surgery outcomes and lower the chances of cancer returning or spreading. Participants receive a combination of treatments including Tislelizumab given on days 1 and 22, and continuous daily Afatinib from days 1 to 42. They also receive injections of the lysogenic HSV virus directly into lymph nodes, with dosing based on lymph node size, given twice two weeks apart. After these treatments, patients undergo standard surgical removal of the tumor. The HSV virus injection includes an initial dose-escalation phase followed by a dose-expansion phase to find the most effective dose. During the study, patients are closely monitored for side effects and treatment tolerance, including checking for dose-limiting toxicities during surgery. Researchers will assess how well the tumor responds to treatment by examining major and complete pathological responses and overall tumor shrinkage up to eight weeks after treatment. They will also monitor adverse events for up to 12 weeks and follow disease-free survival for one year. The study duration and procedures are planned to provide detailed information on the safety and effects of this combined therapy.

Researchers are evaluating the safety and effectiveness of a new neoadjuvant treatment combining Cadonilimab, a PD-1CTLA-4 bispecific antibody, with platinum-based chemotherapy Paclitaxel Polymeric Micelles for Injection and Cisplatin for patients with locally advanced esophageal squamous cell carcinoma. This Phase 2 clinical trial aims to measure pathologic complete remission rates after 2 to 4 treatment cycles, alongside other measures like objective remission rate, major pathologic remission rate, surgical removal rate, and 2-year survival outcomes. Participants receive Cadonilimab intravenously at 10 mgkg on day 3 every 3 weeks, combined with Paclitaxel Polymeric Micelles administered intravenously 230 mgm2 for cycle 1 possibly increased to 260 mgm2 for cycles 2-4 depending on blood counts and side effects and Cisplatin intravenously at 25 mgm2 daily for 3 days every 3 weeks. Treatment lasts approximately 12 weeks, covering 2 to 4 cycles before surgery. Throughout the study, participants undergo regular assessments including pathological evaluation after surgery to determine remission, as well as monitoring of overall and progression-free survival over 2 years. Safety and organ function are closely observed, with eligibility requiring adequate heart, liver, kidney, and blood function. Participants are followed from treatment initiation through surgery and beyond to evaluate clinical outcomes and side effects.

Researchers are evaluating the effects of Poly L-lactic Acid PLLA biostimulator treatment on women at various menopausal stages who have moderate-to-severe cheek wrinkles. This randomized, prospective study aims to assess changes in protein expression in the skin after treatment, using punch biopsies taken at several follow-up visits compared to baseline. The study is sponsored by Galderma R&D and involves about 40 participants across two sites. Participants will receive Sculptraae, a biostimulator device, applied to both cheeks in up to three treatments spaced four weeks apart. Initially, a punch biopsy is taken on one pre-auricular cheek side at baseline. After the first and second treatments, participants may receive a third optional treatment at week 8. At 12 weeks after the last Sculptra treatment, half of the subjects will have a second punch biopsy on the opposite cheek side, with the rest receiving this biopsy at 36 weeks post-treatment. Follow-up visits occur at 24 weeks after the final treatment. During the study, participants will be monitored through physical assessments, biopsy procedures, and self-assessment questionnaires measuring satisfaction at 12, 24, and 36 weeks after treatment. Researchers will analyze protein expression changes and track participant experiences. The study includes safety and adherence monitoring throughout the treatment and follow-up period, lasting up to 36 weeks after the last Sculptra treatment.

Researchers are evaluating the effects of different pollen extracts on menopausal symptoms in healthy women aged 45 to 65 years. The study aims to compare changes in symptom severity, measured by the Menopause Rating Scale MRS, between Graminex Water Soluble Pollen Extract WSPE, Graminex Lipid Soluble Pollen Extract LSPE, and a placebo over 36 weeks. This Phase 2, randomized, triple-blind, placebo-controlled trial assesses how these extracts impact menopausal symptoms including vasomotor, psychological, and urogenital domains. Participants are randomly assigned to receive either Graminex WSPE, a water soluble pollen extract standardized to 6% amino acids Graminex LSPE, a lipid soluble pollen extract standardized to 7% phytosterols or a placebo. The intervention lasts for 36 weeks, during which participants complete the MRS assessment tool at baseline and at several points up to Week 36 to rate their menopausal symptoms. The study uses a parallel design and quadruple masking to compare the effects of these treatments. Throughout the study, participants provide symptom ratings using the MRS at baseline, Week 6, 12, 24, and 36. Researchers monitor changes in total MRS scores as well as individual symptom domains such as sleep disturbance, mood, and physical symptoms. The trial includes regular assessments to capture symptom changes over time, with safety and adherence monitored by qualified investigators. Participation will last approximately 36 weeks from baseline to the final outcome measurement.