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Researchers are evaluating the effectiveness of tinidazole for treating Mycoplasma genitalium MG infection in male patients diagnosed with non-gonococcal urethritis NGU. This study focuses on men who have tested positive for MG and have received standard doxycycline therapy. Tinidazole is a drug approved for other infections but has not been systematically tested against MG, and this trial aims to assess its potential in treating this condition. Participants will receive tinidazole starting with a 2-gram dose orally on the first day, followed by 500 mg taken twice daily for the next nine days. This is a single-arm study conducted at a sexual health clinic where men with NGU will be enrolled. Treatment effectiveness will be evaluated through microbiologic tests 21 days after completing the tinidazole regimen. During the study, urine specimens will be collected at diagnosis, at the start of tinidazole therapy, and at the test of cure visit. These samples will be used to assess bacterial load, culture, and resistance to tinidazole. The main outcome is microbiologic cure of MG by day 38. Participants will be monitored for antimicrobial susceptibility and resistance mutations to better understand treatment response. The study will be conducted until August 2026.

Researchers are evaluating the combination of CGT9486 and sunitinib compared to sunitinib alone in patients with locally advanced, unresectable, or metastatic Gastrointestinal Stromal Tumors GIST. This Phase 3, open-label international trial involves multiple parts, including dose confirmation, drug interaction assessments, and efficacy comparisons. The study also includes substudies focusing on drug-drug interaction potential and first-line treatment in patients with specific genetic mutations KIT exon 9. Approximately 482 patients will participate across these parts.

Researchers are studying the use of 211astatineAt-BC8-B10, a radioactive substance linked to a monoclonal antibody, in patients with high-risk acute myeloid leukemia, acute lymphoblastic leukemia, myelodysplastic syndrome, or mixed-phenotype acute leukemia. The trial is a phase III dose-escalation study focused on evaluating side effects and determining the best dose before patients undergo donor stem cell transplant. This approach aims to target cancer cells with radiation while minimizing effects on healthy cells. Participants receive 211At-BC8-B10 intravenously over 6 to 8 hours on day -7 and may also receive 131I-BC8-B10 on the same day. They receive fludarabine phosphate intravenously on days -4, -3, and -2, followed by total-body irradiation and peripheral blood stem cell transplant on day 0. Patients take cyclosporine orally or intravenously every 12 hours from days -3 to 56, with tapering schedules depending on donor type, and mycophenolate mofetil orally or intravenously starting shortly after transplant with dosing adjustments over time. Some participants may have imaging scans, bone marrow aspirate, and blood samples collected during the study. Throughout the study, patients are closely monitored for treatment effects and side effects, including dose-limiting toxicities up to 30 days post-transplant and veno-occlusive disease up to 60 days. Additional outcomes include engraftment, chimerism, graft versus host disease, remission status, and survival tracked up to two years. Follow-up visits occur at 100 days, then 6, 9, 12, 18, and 24 months after treatment to assess recovery and long-term effects.

Researchers are evaluating a radioactive agent linked to an antibody called 211At-BC8-B10 followed by donor stem cell transplant for patients with high-risk acute leukemia or myelodysplastic syndrome that has returned or is not responding to treatment. This phase III trial studies the side effects and best dose of this treatment. The antibody may interfere with cancer cell growth, and the transplant aims to help the patients bone marrow produce healthy blood cells. Additional medications are given to help prevent complications like graft versus host disease. Participants receive a preparative regimen including an infusion of 211At-BC8-B10 over 6-8 hours on day -8, followed by chemotherapy drugs fludarabine and cyclophosphamide over several days. Total-body irradiation TBI is given on day -1. On day 0, patients undergo peripheral blood stem cell or bone marrow transplant. After transplant, patients receive medications cyclophosphamide, mycophenolate mofetil, and tacrolimus to reduce the risk of graft versus host disease. Granulocyte colony-stimulating factor G-CSF is started on day 5 to support white blood cell recovery. Throughout the study, patients undergo bone marrow biopsies, aspirations, and blood sample collections. They are followed up at day 100 and then at 6, 9, 12, 18, and 24 months after treatment. Researchers monitor side effects including dose-limiting toxicities, remission rates, engraftment success, donor chimerism, immune recovery, graft versus host disease, survival, and disease-free survival. Patient health and safety are regularly assessed during and after treatment.

Researchers are evaluating the safety, tolerability, and early effects of 4D-710, an investigational gene therapy, in adults with cystic fibrosis CF lung disease who cannot use or tolerate existing CFTR modulator therapies. A sub-study also includes adults with advanced CF lung disease or frequent lung flare-ups who are currently on CFTR modulator therapy. This Phase 12 open-label trial aims to find appropriate dosing and assess potential benefits for these patient groups. Participants receive a single inhaled dose of 4D-710, which is a gene therapy designed to deliver a corrected version of the CFTR gene to lung cells. The study includes a dose exploration phase for those ineligible for modulator therapy, a dose expansion phase at selected doses, and a sub-study for participants on modulator therapy receiving various doses. Each participant undergoes one administration of the therapy during the trial. Throughout the study, participants are monitored for adverse events over a 60-month period. Evaluations include lung function tests, oxygen saturation measurements, and tracking of pulmonary exacerbations. Participants maintain their existing treatments if applicable, and researchers assess safety and early signs of effectiveness. The total study duration extends up to approximately nine years, including long-term observation after dosing.

Researchers are evaluating the use of XYOSTED as a testosterone replacement therapy in adolescent males aged 12 to under 18 years with primary or secondary hypogonadism, a condition where the body produces little or no testosterone. This Phase 34 open-label study aims to assess how well XYOSTED supports the continuation or start of puberty, along with its safety and the testosterone levels it maintains. Participants will receive XYOSTED injections at doses tailored to their weight and targeted pubertal stage. Dose adjustments will be made based on testosterone levels measured at specific intervals after dosing, with evaluations approximately every three months to reach the desired hormone levels. After completing the 52-week initial study period, participants may enter a 24-month extension to further monitor long-term safety and treatment effects. Throughout the study and extension, participants will undergo clinical examinations including pubertal staging, blood tests for testosterone and other labs, bone density scans, body composition assessments, and X-rays to monitor bone age. Researchers will track changes in puberty progression, bone health, body measurements, and hormone levels. Participants will attend regular clinic visits every six months during the extension phase to continue safety and pharmacokinetic evaluations.

Researchers are evaluating how well fluorine F 18 fluorthanatrace 18FFTT positron emission tomography PET works in imaging patients with metastatic breast cancer who are receiving standard treatments using PARP inhibitors, with or without immune checkpoint inhibitors ICI. This study focuses on detecting how tumors respond clinically to these treatments by targeting and visualizing PARP1 expression in tumor cells using the 18FFTT tracer during PET scans. PARP inhibitors block an enzyme involved in repairing cell damage, potentially causing tumor cells to die, while ICIs may assist the immune system in attacking cancer and slowing tumor growth. Participants are assigned to one of two groups. In Arm I, patients receive 18FFTT intravenously and undergo PET scans 60-75 minutes later on the first day of starting PARP inhibitor treatment with or without ICI, and again at 12 weeks. Following this, they have standard FDG PETCT scans and follow-ups at 12 weeks and 6 months, with optional tissue biopsies during screening and follow-up. In Arm II, patients receive 18FFTT and PET scans similarly on day 1 but only have follow-up FDG PETCT scans and may have biopsies during screening. After initial imaging, patients are monitored for up to 6 months or until disease progression. During the study, participants undergo several assessments including 18FFTT PET scans, FDG PETCT scans, tissue biopsies, and health record reviews. Researchers measure the overall response rate up to 6 months to evaluate tumor response to treatment. Safety and progression are monitored throughout, with multiple imaging and biopsy timepoints to track changes. Participation involves scheduled visits for imaging and scans, with treatment and evaluations following standard care protocols.

Researchers are conducting a Phase 3, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of rilzabrutinib in adults with active Immunoglobulin G4-related disease IgG4-RD. The study aims to measure the time to the first adjudicated disease flare and assess other important outcomes such as flare-free rates, disease activity control, glucocorticoid use, and safety parameters including adverse events, laboratory tests, and electrocardiograms ECG. Participants will be assigned to one of two groups one receiving rilzabrutinib tablets and the other receiving placebo tablets, both administered orally. The treatment period lasts 52 weeks in a double-blind manner, preceded by a 4 to 6 week screening period. After treatment, there is a 2-week follow-up, with an optional open-label extension lasting up to 108 weeks. The study includes a total of 16 visits during the main period and up to 9 additional visits during the optional extension. During their participation, adults diagnosed with IgG4-RD will undergo repeated imaging procedures such as CT, MRI, PET, or ultrasound to assess disease status. Researchers will monitor disease flares, remission status, glucocorticoid dosage, clinical activity scores, laboratory values, vital signs, and ECG results. Safety monitoring continues up to week 160 to capture treatment-emergent adverse events. Overall, participation lasts up to 60 weeks, with possible extension for those continuing in the optional phase.

This research evaluates how well a cancer vaccine called STEMVAC works alongside chemotherapy in treating patients with PD-L1 negative, triple-negative breast cancer that has spread to other parts of the body. STEMVAC targets proteins found on breast cancer stem cells and aims to boost the immune system to attack tumor cells. This phase II trial focuses on patients with metastatic triple-negative breast cancer who have not received prior cancer immunotherapy in this setting. Participants receive standard-of-care chemotherapy as decided by their oncologist. They also get three initial doses of STEMVAC combined with sargramostim injected into the skin every 21 to 28 days, timed around their chemotherapy treatments. Following the initial doses, two booster doses of STEMVAC with sargramostim are given at four and seven months, and then every six months if there is no disease progression or unacceptable side effects. Image-guided biopsies, CT or PET scans, and blood samples are collected during the study, including possibly during screening. During the study, participants undergo regular scans and biopsies for research purposes while receiving treatment. After completing the study treatment, they have a follow-up visit at 21 or 28 days and then visits every six months for up to three years to monitor their health and cancer status. Researchers assess immune responses to the vaccine, treatment safety, overall response rates, progression-free survival, and overall survival throughout the study period.

Researchers are studying treatments for locally advanced or metastatic colorectal cancer mCRC that cannot be removed by surgery and has a specific KRAS G12C gene mutation. This trial aims to evaluate if adding the targeted therapies calderasib and cetuximab to the standard chemotherapy regimen mFOLFOX6 can provide better outcomes compared to mFOLFOX6 with or without bevacizumab. The study focuses on the safety and tolerability of these combinations and whether they can help people live longer without their cancer growing or spreading. Participants will be assigned to one of two groups. One group will receive calderasib orally, cetuximab every two weeks, and mFOLFOX6 chemotherapy including oxaliplatin, leucovorin or levofolinate calcium, and 5-fluorouracil every two weeks. The other group will receive mFOLFOX6 chemotherapy with or without bevacizumab every two weeks, based on the investigators decision. Treatments will continue until certain stopping criteria are met. During the study, participants will be monitored for side effects and treatment tolerance, with regular assessments of cancer progression. Researchers will measure outcomes such as dose-limiting toxicities, adverse events, progression-free survival, and overall survival. Quality of life will also be evaluated through questionnaires. The study may last up to several years, with monitoring continuing for safety and effectiveness throughout the treatment period and follow-up.