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Found 11 Actively Recruiting clinical trials
Actively Recruiting
Researchers are evaluating the safety, tolerability, and how the body processes HRS-3802 when used alone in patients with advanced malignant solid tumors. This phase I clinical study aims to better understand these factors in patients whose tumors have either not responded to standard treatments or for whom no effective standard treatments exist. The study is sponsored by Shandong Suncadia Medicine Co., Ltd. Participants will receive HRS-3802 as a single treatment. The study is open-label, meaning both participants and researchers know the treatment being given. The research includes monitoring for side effects and determining the maximum tolerated dose and recommended dose for future studies. Treatment effects will be assessed over several months, with follow-up evaluations up to two years for progression and response. During the study, participants will be monitored regularly for adverse events, dose-related toxicities, and tumor response using RECIST 1.1 criteria. Safety assessments will occur every four weeks, especially during the first 28 days of treatment. Researchers will also evaluate outcomes such as objective response rate, duration of response, and progression-free survival. Participants are expected to survive at least 12 weeks and will be followed for up to two years to assess treatment impact and safety.
Actively Recruiting
Researchers are evaluating the safety, tolerability, and therapeutic effects of BNT113 combined with pembrolizumab compared to pembrolizumab alone as a first-line treatment for patients with unresectable recurrent or metastatic head and neck squamous cell carcinoma HNSCC positive for human papilloma virus 16 HPV16 and expressing the protein PD-L1 with a combined positive score of 1 or higher. This is an open-label, multi-site, Phase IIIII clinical trial consisting of two parts an initial safety run-in phase and a randomized phase. In the safety run-in phase Part A, patients receive BNT113 in combination with pembrolizumab to confirm safety and tolerability at selected dose levels. The randomized phase Part B compares BNT113 combined with pembrolizumab against pembrolizumab monotherapy. Treatments are given by intravenous injection or infusion and continue for up to 24 months. An optional pre-screening phase allows tumor samples to be tested for HPV16 DNA and PD-L1 expression before the main trial screening. Participants will be closely monitored throughout the study. Assessments include safety evaluations, tumor response, and survival outcomes such as overall survival and progression-free survival. Tumor tissue samples must be provided for testing. Researchers will measure treatment-emergent adverse events, response rates, duration of response, and disease control. The study may last up to 48 months, with ongoing safety and efficacy monitoring during and after treatment.
Actively Recruiting
Researchers are investigating a combination therapy of BNT326 and pumitamig also called BNT327 or PM8002 in adults with advanced or metastatic non-small cell lung cancer NSCLC who may have relapsed, progressive, or treatment-nafve disease. This multi-site, open-label study aims to find the best dose levels for this combination, assess how well participants tolerate the therapy, including side effects, and evaluate its ability to shrink tumors in this population. The study has three parts Part 1 focuses on finding safe dose levels for the combination Part 2a expands the dose evaluation to assess preliminary effectiveness and safety Part 2b is a randomized phase to optimize doses and understand the contribution of each drug component. Participants will receive intravenous infusions of BNT326 and pumitamig or pumitamig alone in some arms. Treatment continues until disease progression, unacceptable side effects, withdrawal, study end, or up to 24 months. Dose levels for later parts are chosen based on earlier safety and efficacy data. Participants will go through screening, treatment, safety follow-up, efficacy follow-up, and long-term survival follow-up phases, with total involvement expected to last about 36 months unless treatment benefit continues. Assessments include monitoring for dose-limiting toxicities, adverse events, tumor response, progression-free survival, overall survival, and pharmacokinetics of the drugs. Safety evaluations continue up to 90 days after treatment ends, and antibody responses to the drugs are also measured for up to one year post-treatment.
Actively Recruiting
Researchers are studying women with a newly diagnosed invasive breast cancer that is node negative and 3 cm or smaller in size to compare two types of radiation therapy after breast-conserving surgery BCS. The study aims to see if partial breast irradiation PBI given once daily over one week is not worse than whole breast irradiation WBI in preventing cancer return and whether it results in better cosmetic outcomes. This is a randomized, single-blind trial focusing on local recurrence and patient-assessed cosmesis three years after treatment. Participants will be randomly assigned to receive either PBI or WBI. Both treatments deliver a total of 26 Gy radiation in 5 fractions, given once daily over 5 to 7 days with up to 8 days allowed for scheduling reasons. PBI targets the tumor bed plus a margin of normal tissue, while WBI targets the whole breast. Patients will not know which treatment they receive to avoid bias in cosmetic assessments. Stratification factors include tumor size, estrogen receptor status, and clinical center. During the study, participants will be monitored for local recurrence annually for five years and will assess their cosmetic outcome at three and five years post-treatment. Researchers will also evaluate survival, disease-free survival, radiation side effects, and quality of life at various intervals. Clinical assessments and nurse evaluations of cosmesis will occur at three and five years. Overall, participant involvement spans several years with multiple follow-up visits to measure outcomes and safety.
Actively Recruiting
Researchers are evaluating a new medicine called GSK5764227, which delivers a toxin directly to cancer cells to destroy them while sparing healthy cells. This Phase 1b2 clinical study focuses on participants with advanced solid tumors, including metastatic colorectal and prostate cancers. The study aims to assess the safety, tolerability, how the body processes the drug, immune responses, and whether the treatment can shrink or control the cancer. Participants will receive GSK5764227 combined with standard treatments or other agents. The study includes specific groups for metastatic colorectal cancer and metastatic castration-resistant prostate cancer. Treatments include GSK5764227 along with drugs like bevacizumab, fluorouracil, leucovorin, and enzalutamide. The study is non-randomized and unblinded, with participants assigned to one of several experimental cohorts. During the trial, participants will be monitored for adverse events, dose-related toxicities, vital signs, body weight, laboratory tests, heart function, and overall performance status for up to about 31 weeks. Additional evaluations include measuring drug levels in the blood, immune responses against the drug, tumor response rates, disease control, and progression-free survival for up to approximately 112 weeks. The study will track safety and treatment effects closely throughout the participation period, which may last over two years for some assessments.
Actively Recruiting
Researchers are evaluating the study drug sacituzumab govitecan-hziy SG given at an alternative dose and schedule in participants with advanced triple-negative breast cancer TNBC. The study aims to assess the safety, tolerability, and effects on tumor response and progression-free survival. This trial includes Phase 1 and Phase 2 stages to explore both preliminary and expanded safety and efficacy of SG. During Phase 1, participants receive SG intravenously to evaluate initial safety, tolerability, pharmacokinetics, and early efficacy. Phase 2 expansion continues the evaluation of safety, efficacy, and pharmacokinetics with the alternative dosing schedule. Participants will receive SG until their disease progresses, unacceptable side effects occur, or other discontinuation reasons arise. Participants will be monitored through various assessments including imaging scans to measure tumor response, blood tests for safety and drug levels, and tracking of side effects and treatment tolerability. The main outcomes measured include dose-limiting toxicities, adverse events, laboratory abnormalities, objective response rate, and progression-free survival over up to nine months. Safety and drug concentration data will be collected for up to three years, supporting long-term evaluation.
Actively Recruiting
Researchers are evaluating the safety and effectiveness of BGB-16673 compared to pirtobrutinib in adults with relapsed or refractory chronic lymphocytic leukemia CLL or small lymphocytic lymphoma SLL who have previously been treated with a covalent Bruton tyrosine kinase inhibitor cBTKi. The study is a phase 3, open-label, randomized trial sponsored by BeOne Medicines, aiming to assess treatment options for these patients. Participants are randomly assigned to receive either BGB-16673 or pirtobrutinib, both taken orally. This parallel assignment design compares these two drugs directly. The treatments continue with monitoring up to approximately three years to observe progression-free survival and other outcomes. The study began in September 2025 and is expected to complete in April 2028. During the trial, participants will undergo regular assessments including imaging scans to measure disease status, quality of life questionnaires, and monitoring for adverse events. Outcomes such as overall survival, response rates, duration of response, and time to next treatment are tracked. Safety and quality of life will be evaluated throughout the study period, which may last up to about three years for each participant.
Actively Recruiting
Researchers are evaluating whether the combination of vicadrostat BI 690517 and empagliflozin helps adults with heart failure who have symptoms and a left ventricular ejection fraction LVEF of 40% or more. This phase III study is designed to compare the effects of vicadrostatempagliflozin tablets versus placeboempagliflozin tablets on heart failure outcomes. The study aims to understand if this combined treatment improves health and reduces heart-related events. Participants are randomly assigned to one of two groups one group takes vicadrostat plus empagliflozin tablets once a day, and the other takes placebo plus empagliflozin tablets once a day. The study has no fixed duration and continues as long as participants benefit and tolerate the treatment. Throughout the study, participants visit their doctors regularly for health checks, and study staff may also contact them by phone to monitor well-being and any side effects. During the study, researchers monitor participants health through regular doctor visits and phone contacts. They collect data on heart-related events such as cardiovascular death, hospitalizations for heart failure, and urgent visits for heart failure over up to 42 months. Participants also answer questions about their symptoms and well-being. The study carefully tracks safety and treatment tolerance while gathering information to determine if the combined treatment helps people with heart failure.
Actively Recruiting
Researchers are evaluating the safety and effectiveness of ficerafusp alfa combined with pembrolizumab compared to placebo with pembrolizumab for adults with first-line PD-L1-positive, recurrent or metastatic Head and Neck Squamous Cell Carcinoma. This study focuses on the dual targeting of EGFR and TGF-beta, which contribute to tumor growth and spread. It includes both phase 2 and phase 3 parts to identify the best dose and to compare treatment outcomes. In phase 2, participants are randomized into three groups receiving either higher or lower doses of ficerafusp alfa plus pembrolizumab, or placebo plus pembrolizumab. In phase 3, participants receive the selected optimal biologic dose of ficerafusp alfa with pembrolizumab or placebo with pembrolizumab in a 21 ratio. Treatments are given weekly or every three weeks depending on the drug, with careful monitoring throughout the study. Participants will undergo tumor biopsies or provide archival tissue, and receive regular assessments including imaging scans and lab tests to measure tumor response and safety. Researchers will track side effects, response rates, survival, and quality of life using standardized criteria over approximately 1 to 3 years. Safety monitoring continues up to 90 days after treatment ends. The total study duration extends through long-term follow-up to evaluate overall outcomes.
Actively Recruiting
Researchers are studying metastatic castration-resistant prostate cancer in men who have progressed after treatment with androgen receptor pathway inhibitors. The study aims to compare the length of time patients live without their cancer worsening on imaging when treated with 177Lu-TLX591 plus standard care versus standard care alone. This is a Phase 3 trial with a focus on both efficacy and safety of the new treatment in this patient group. Participants are divided into three parts a safety and dosimetry lead-in with 30 patients, a randomized treatment expansion with approximately 490 patients, and a long-term follow-up period lasting at least 5 years. In the randomized phase, patients receive either 177Lu-TLX591 plus standard of care, which may include enzalutamide, abiraterone, or docetaxel, or standard of care alone. The 177Lu-TLX591 is given as two doses about 14 days apart. Standard care treatments involve oral medications or chemotherapy as specified. During the study, participants will be regularly monitored through scans and other assessments to evaluate cancer progression and safety. Imaging includes PETCT or PETMRI scans to confirm PSMA positivity and detect disease spread. Researchers will track radiographic progression-free survival as the main outcome, along with overall survival and response rates. The long-term follow-up helps assess lasting effects and safety over several years. Participants are expected to adhere to study protocols and radiation safety precautions throughout their involvement.
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