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Found 10 Actively Recruiting clinical trials
Actively Recruiting
Researchers are evaluating the safety, tolerability, and how the body processes HRS-3802 when given alone to patients with advanced malignant solid tumors. This Phase 1 clinical trial focuses on patients who have not responded to standard treatments or for whom no effective standard treatments exist. The study aims to understand how well patients tolerate HRS-3802 and to collect important safety and dosage information. Participants will receive HRS-3802 as a monotherapy. The study is open-label and single-arm, meaning all participants receive the investigational drug without a comparison group. The treatment period includes monitoring for dose-limiting toxicities during the first 28 days, with assessments at 3 weeks for maximum tolerated dose and recommended Phase II dose. The treatment and monitoring occur over an average duration of 5 months, with safety evaluations every 4 weeks after treatment starts. During the study, participants will be regularly assessed for side effects and how severe these are, using various tests and clinical evaluations. Researchers will collect data on adverse events, dose tolerability, and pharmacokinetics of HRS-3802. Participants will also undergo laboratory tests, physical examinations, and follow-up visits to monitor their health and treatment effects. The total involvement time in the study is around five months, with careful safety oversight throughout.
Actively Recruiting
Researchers are evaluating the safety, tolerability, and therapeutic effects of a combination treatment using BNT113 and pembrolizumab compared to pembrolizumab alone for patients with unresectable recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) that is positive for human papillomavirus 16 (HPV16+) and expresses the PD-L1 protein with a combined positive score of 1 or higher. This Phase II/III trial includes patients whose cancer cannot be treated with local therapies and who have not received prior systemic anticancer therapy for their current disease condition. The trial consists of two parts. Part A is a non-randomized Safety Run-In Phase to confirm the safety and tolerability of BNT113 combined with pembrolizumab at the selected dose. Part B is a randomized phase that compares BNT113 plus pembrolizumab against pembrolizumab alone as first-line treatment. Patients in Part A continue their treatment without randomization. Treatments are given by intravenous injection or infusion, and patients may receive either combination therapy or monotherapy for up to 24 months. There is also an optional pre-screening phase to test tumor samples for HPV16 DNA and PD-L1 expression before entering the main trial. Participants undergo regular assessments including tumor measurements based on RECIST 1.1 criteria confirmed by independent review. Researchers monitor treatment-emergent adverse events for up to 27 months in Part A and evaluate overall survival and progression-free survival for up to 48 months in Part B. Tumor tissue samples are collected before treatment to confirm eligibility. The study involves ongoing safety monitoring and efficacy evaluations throughout the treatment and follow-up periods.
Actively Recruiting
Researchers are evaluating a combination treatment using BNT326 and BNT327 in adults with advanced or metastatic non-small cell lung cancer (NSCLC), including those with relapsed, progressive, or treatment-nafve disease. This multi-site, open-label study includes dose-finding and dose-expansion phases to investigate the safety, tolerability, and preliminary effectiveness of this combination therapy. The study targets patients whose tumors are advanced, metastatic, or recurrent with no curative treatment options available and includes participants with different genomic alterations. The study is divided into several parts: Part 1 is a dose escalation phase to find safe dose levels of BNT326 with BNT327; Part 2a expands the dose to further evaluate safety and initial efficacy; Part 2b focuses on dose optimization and understanding the contributions of each component. Participants receive intravenous infusions of BNT326 and BNT327, with some cohorts possibly receiving additional treatments such as pembrolizumab or standard chemotherapy. Treatment continues until disease progression, unacceptable side effects, withdrawal, or a maximum of 24 months. Dose levels for certain cohorts are determined based on earlier phase data, and some parts include randomization to different treatment groups. Participants undergo a screening period before starting treatment, followed by treatment, safety follow-up, efficacy follow-up, and long-term survival monitoring, totaling about 36 months. Researchers assess dose-limiting toxicities within the first 21 days of treatment and monitor adverse events, treatment interruptions, and objective response rates up to 36 months. Tumor measurements, safety labs, imaging, and patient health status are regularly evaluated. The study tracks tolerability and efficacy while ensuring participant safety throughout treatment and follow-up.
Actively Recruiting
Researchers are evaluating two types of radiation treatments for women with small, node-negative breast cancer (3 cm or smaller) after breast-conserving surgery. The study aims to find out if partial breast irradiation (PBI) given once a day over one week is not worse than whole breast irradiation (WBI) in preventing cancer from coming back locally and if it leads to better cosmetic outcomes as assessed by patients three years after treatment. This is a phase 3 randomized trial focusing on the comparison of these two radiation approaches. Participants will be randomly assigned to receive either PBI or WBI. Both treatments deliver a total radiation dose of 26 Gy divided into 5 daily sessions over 5 to 7 days (up to 8 days allowed due to holidays). The radiation is carefully targeted to the appropriate breast area, and the study is single-blinded so that patients do not know which treatment they receive to avoid bias in cosmetic assessments. Treatment planning includes using CT imaging and surgical markers for accurate delivery. During the study, participants will be monitored annually for five years to check for local cancer recurrence. Cosmetic outcomes will be assessed by patients themselves at three and five years post-treatment. Other evaluations include tumor characteristics and receptor status, and treatment safety will be observed. The total participation involves follow-up over several years to understand long-term effects of the treatments.
Actively Recruiting
Researchers are evaluating a new medicine called GSK5764227 combined with standard treatments in people with advanced solid tumors, including types of colon, rectal, and prostate cancer. This Phase 1b/2 clinical study aims to assess the safety, how the body processes the drug, immune responses triggered, and whether the treatment can shrink or control cancer. The study focuses on participants with good performance status and confirmed advanced cancer diagnoses. Participants will receive GSK5764227 along with other approved cancer medicines such as bevacizumab, fluorouracil, leucovorin, or enzalutamide. These drugs will be given according to standard care or combined with the investigational drug. The treatment period includes monitoring for side effects and drug activity lasting up to about 31 weeks. During the study, participants will undergo regular health assessments including vital signs, body weight, lab tests (blood, urine, chemistry), heart function tests (ECG), and performance status evaluations. Researchers will track any adverse events, serious side effects, and dose adjustments. The study also measures the body's response to treatment and monitors safety throughout the duration of participation.
Actively Recruiting
Researchers are evaluating the study drug sacituzumab govitecan-hziy (SG) given at an alternative dose and schedule in adults with advanced triple-negative breast cancer (TNBC). This Phase 1/2 open-label study aims to assess the safety, tolerability, and effectiveness of SG, focusing on outcomes like objective response rate (ORR) and progression-free survival (PFS). Phase 1 will explore preliminary safety and pharmacokinetics, while Phase 2 will expand the evaluation of these factors in a larger group. Participants will receive SG administered intravenously. Phase 1 includes individuals with unresectable, locally advanced or metastatic TNBC who have relapsed or are refractory after prior treatments. Phase 2 includes similar patients who have not yet received systemic therapy for advanced disease and whose tumors meet PD-L1 status requirements or have specific prior immunotherapy conditions. During Phase 1 safety run-in, only those with UGT1A1 wild-type genotype are eligible; after this, all UGT1A1 genotypes may participate. Participants will undergo tumor assessments by CT or MRI according to RECIST criteria and have their safety monitored through adverse event tracking, laboratory tests, and dose adjustments as needed. The study measures include percentages of dose-limiting toxicities, adverse events, laboratory abnormalities, and treatment modifications, along with ORR and PFS up to 9 months. The study also monitors long-term safety up to 3 years after the last dose.
Actively Recruiting
This study is open to adults aged 18 or above legal age with heart failure. People can join the study if they have heart failure symptoms and a left ventricular ejection fraction (LVEF) of 40% or more. The purpose of this study is to find out whether vicadrostat (BI 690517) in combination with empagliflozin helps people with heart failure. Participants are put into 2 groups by chance. Every participant has an equal chance of being in each group. The groups are: * Vicadrostat/empagliflozin group: participants take vicadrostat/empagliflozin as tablets once a day. * Placebo/empagliflozin group: participants take placebo/empagliflozin as tablets once a day. Participants can stay in the study as long as they benefit from treatment and can tolerate it. During this time, they visit their doctors regularly. The doctors regularly check participants' health and take note of any unwanted effects. The study staff may also contact the participants by phone. Participants also regularly answer questions about their well-being. The study does not have a fixed duration. It continues until there is enough data to see if the treatment is working.
Actively Recruiting
Researchers are evaluating the safety and effectiveness of an investigational drug called ficerafusp alfa combined with pembrolizumab compared to placebo with pembrolizumab in adults with PD-L1-positive recurrent or metastatic Head and Neck Squamous Cell Carcinoma (HNSCC). This study includes both Phase 2 and Phase 3 parts. Ficerafusp alfa targets two cancer-related proteins, EGFR and TGF-beta, which play roles in tumor growth and spread. The goal is to find the best dose and then compare treatment outcomes between groups. In Phase 2, participants will be randomly assigned to one of three groups: ficerafusp alfa 1500 mg weekly plus pembrolizumab every three weeks, ficerafusp alfa 750 mg weekly plus pembrolizumab every three weeks, or placebo weekly plus pembrolizumab every three weeks. Phase 3 will randomize participants to the selected ficerafusp alfa dose plus pembrolizumab or placebo plus pembrolizumab. Treatments will continue as scheduled, and safety, tolerability, and treatment responses will be closely monitored throughout. Participants will undergo assessments including scans to measure tumor response using RECIST 1.1 criteria, safety evaluations for side effects, and survival tracking. Safety monitoring includes checking for treatment-related adverse events up to 30 days after treatment ends and serious events up to 90 days afterward. The study will follow participants for approximately one year in Phase 2 and up to three years in Phase 3 to evaluate treatment effectiveness and overall survival.
Actively Recruiting
The primary objective of the study is to compare radiographic progression-free survival (rPFS) in participants who receive 177Lu-TLX591 with SOC to rPFS in participants who receive SOC only. This study consists of three Parts: * Part 1: Safety and Dosimetry Lead-in, * Part 2: Randomized Treatment Expansion, and * Part 3: Long-term Follow-up The study will commence with a 30-patient safety and dosimetry lead-in (Part 1) and proceed to a randomization treatment expansion in approximately 490 patients (Part 2). Patients in Part 2 will be randomized in a 2:1 ratio to receive either 177Lu-TLX591 + Standard of Care SoC (Group A), or SoC alone (Arm B). SoC in this trial is either: ARPI (enzalutamide or abiraterone) or docetaxel. All patients will be followed in long-term follow-up for at least 5 years from the first therapeutic dose, death, or loss to follow up (Part 3). Only patients that meet PSMA-positivity criteria per Blinded Independent Central Review (BICR) will be eligible for this study.
Actively Recruiting
Researchers are evaluating the safety and effectiveness of a drug called YN001 in patients with coronary atherosclerosis in Australia. This study focuses on patients who have at least one coronary artery blockage identified by coronary computed tomography angiography (CCTA). The trial is a Phase 2, multicenter, randomized, open-label study designed to see if YN001, given along with evolocumab, can reduce the amount of plaque in coronary arteries over 13 weeks. The study will enroll 24 patients who will be randomly assigned to one of two groups receiving different doses of YN001. Both doses of YN001 will be given intravenously once a week for 13 weeks. In addition, all participants will receive evolocumab 140 mg by subcutaneous injection every two weeks. The study includes a screening period lasting up to 41 days, a baseline period, a 13-week treatment and observation period, and a 14-day safety follow-up after the last dose. Participants will undergo CCTA scans at the start and at week 13 to measure changes in coronary plaque volume and composition. Throughout the study, patients will be monitored for safety and treatment effects. Researchers will assess adherence and collect data on potential side effects. The total participation time covers screening, treatment, and follow-up periods as scheduled in the protocol.