Zhongzheng District

Researchers are studying metastatic castration-resistant prostate cancer mCRPC to find new treatment options. This trial evaluates if the study medicine ifinatamab deruxtecan I-DXd or MK-2400 helps people live longer overall and experience slower cancer growth or spread compared to chemotherapy. The study is a Phase 3 trial comparing I-DXd with standard chemotherapy for mCRPC patients. Participants are randomly assigned to receive either I-DXd at 12 mgkg every 3 weeks through intravenous infusion or docetaxel chemotherapy at 75 mgm2 every 3 weeks combined with daily prednisone pills. Treatment continues until the disease progresses, unacceptable side effects occur, or treatment is stopped for other reasons. Premedication is given before each dose of I-DXd to help prevent nausea and vomiting. During the study, participants will have regular visits for treatment and monitoring. Researchers will assess overall survival and radiographic progression-free survival for up to about 36 months. Additional measures include response rates, time to pain progression, PSA progression, and adverse events. The study tracks safety, treatment effects, and quality of life over a long follow-up period to better understand the potential benefits and risks of I-DXd compared to chemotherapy.

Researchers are investigating new treatments for metastatic cervical cancer, which is cancer that has spread beyond the cervix, the lower part of the uterus. This study evaluates the safety and effectiveness of the antibody drug conjugate sacituzumab tirumotecan sac-TMT combined with pembrolizumab and bevacizumab. The goal is to find out if these treatments, given together or with some variations, help patients live longer or delay cancer progression compared to standard care. The study has two parts. In Part 1, participants receive sac-TMT, pembrolizumab, and bevacizumab together to assess safety. In Part 2, all participants first get standard induction treatment with pembrolizumab, paclitaxel, and cisplatin or carboplatin, possibly with bevacizumab. Those whose cancer does not worsen then enter maintenance treatment, where they are randomly assigned to receive either pembrolizumab alone or sac-TMT plus pembrolizumab, with optional bevacizumab. Participants are involved for up to about 20 months during maintenance treatment after up to 4 months of induction. The study monitors safety by tracking side effects and treatment discontinuations. Effectiveness is measured by progression-free survival and overall survival up to several years. Quality of life and physical functioning are also assessed through questionnaires. Treatments and evaluations occur through regular intravenous infusions and periodic monitoring visits.

Researchers are investigating new treatments for radiographic axial spondyloarthritis r-axSpA, a form of arthritis causing pain, stiffness, and swelling in the spine and pelvis joints. This condition shows visible damage on X-rays. The study aims to evaluate if different doses of the medicine tulisokibart can improve r-axSpA symptoms compared to a placebo, which helps measure the medicines effects accurately. Participants will be assigned to one of several groups receiving high, medium, or low doses of tulisokibart, or a placebo. The study includes a 16-week placebo-controlled phase. After that, participants receiving the low dose or placebo will be re-assigned to medium or high doses. Following this, there is a long-term extension lasting 124 weeks, which has a 40-week main extension and an 84-week optional extension, allowing continued treatment and observation. Throughout the study, participants will have regular assessments to monitor symptoms and disease activity using various indexes and imaging scores. Researchers will track the percentage of participants who achieve improvement at week 16 and monitor safety by recording adverse events up to approximately 154 weeks. The study uses injections of tulisokibart or placebo under the skin and includes ongoing evaluations of physical function, pain, inflammation, and quality of life.

Researchers are studying the use of digital twin technology to improve exoskeleton control for healthy individuals. This project aims to create a virtual model that runs parallel to the users movements, calculating the torque needed at each joint to maintain stable walking without falling. This approach addresses current limitations in exoskeleton applications that focus mainly on motor torque compensation without considering overall motion stability and fall prevention. Participants will wear sensors such as inertial measurement units IMU and electromyography EMG devices on their lower limbs to non-invasively capture body signals while performing various common actions or transitions between actions. The system will analyze joint angles, angular velocity, and acceleration to predict human intent and adjust exoskeleton support accordingly. This includes warning and reducing auxiliary forces when movements fall outside a stable gait, and recognizing changes in movement modes like stopping or sitting. During the study, participants joint angles, muscle activity, and overall movement intentions will be monitored over three years. The data collected will help refine the machine learning models predicting human intent. Participation involves wearing sensors and performing movements while researchers collect and analyze body signal data. Safety and stability will be assessed continuously, with no invasive procedures involved. The study is led by National Taiwan University Hospital and allows healthy volunteers aged 18 to 80 years.

Researchers are evaluating targeted therapies and immunotherapy for people with metastatic colorectal cancer mCRC that have specific biomarkers. This open-label, exploratory Phase 11b study aims to assess the safety and effectiveness of these treatments alone or in combination. Eligible participants will be assigned to treatment arms based on their tumor biomarker test results to better understand how these therapies work in different subgroups of mCRC. Participants may receive various drug combinations including oral inavolisib, intravenous IV cetuximab, bevacizumab, atezolizumab, tiragolumab, SY-5609, divarasib, and chemotherapy regimens such as FOLFOX or FOLFIRI. Treatment cycles typically last 21 or 28 days, with dosing schedules varying across arms, including daily oral medications and IV infusions on specific days. Some arms are actively recruiting, while others are closed or not currently enrolling. During the study, participants will undergo regular assessments including tumor measurements to evaluate response, blood tests to monitor drug levels and safety, and collection of tumor tissue for biomarker research. The primary outcome is the objective response rate over about 7 years. Secondary outcomes include duration of response, disease control rate, and adverse event monitoring. Participants are followed long-term to assess treatment effects and safety, with study participation lasting up to approximately 84 months.

Researchers are evaluating a new treatment option for children with certain types of cancer, specifically hepatoblastoma and rhabdomyosarcoma RMS that have either come back after treatment or did not respond to prior therapies. Hepatoblastoma is a common liver cancer in very young children, while RMS begins in muscle cells and often appears in areas such as the head, neck, bladder, arms, or legs. This study is a phase 12 trial aiming to assess the safety and effectiveness of a drug called patritumab deruxtecan HER3-DXd in these pediatric patients. Participants will receive patritumab deruxtecan through an intravenous infusion on the first day of each three-week cycle. The study includes two parts first, a safety lead-in phase to determine a tolerable dose and assess safety, followed by a phase to evaluate how well the treatment works in shrinking or eliminating cancer. Participants will continue treatment until disease progression or other reasons for stopping occur. Throughout the study, children will be closely monitored for side effects and how the drug behaves in their bodies over time, with various blood tests and assessments conducted at designated times up to approximately five years. Researchers will measure outcomes such as the percentage of patients experiencing toxicities or adverse events, treatment response rates, and survival metrics. This long-term follow-up aims to gather comprehensive data on safety and effect.

Researchers are evaluating PTX-9908 Injection in a Phase III clinical study involving patients with non-resectable hepatocellular carcinoma HCC who have undergone transarterial chemoembolization TACE treatment. The study aims to assess the safety, tolerability, and antitumor activity of PTX-9908 Injection in this patient population. The trial includes an open-label dose escalation phase followed by a randomized placebo-controlled dose expansion phase to better understand the treatments effects. In Phase I, the study uses an open-label design with escalating doses of PTX-9908 Injection given intravenously at several dose levels. Patients receive one dose per day for five days in the first week excluding weekends and holidays, then one dose weekly for three more weeks, completing a four-week treatment period followed by two weeks of follow-up. Phase II randomizes approximately 24 patients to receive either PTX-9908 Injection or a placebo in a 21 ratio, with dosing schedules extending to 12 weeks and a two-week follow-up period. Participants will undergo regular assessments including monitoring of adverse events, dose limiting toxicities, tumor response, and blood tests at scheduled timepoints throughout treatment and follow-up periods. Safety is evaluated weekly in Phase I and through week 16 in Phase II. Additional measures include pharmacokinetics, tumor response evaluations, and biomarkers such as AFP levels. The total study duration varies per phase but includes intensive monitoring to assess treatment effects and patient safety.

Researchers are studying repotrectinib TPX-0005 in adults and adolescents with advanced solid tumors that have specific gene rearrangements in ALK, ROS1, or NTRK1-3. The trial aims to find the safest and most effective dose in Phase 1, and then evaluate how well the drug works in Phase 2 across different patient groups with these gene changes. This includes patients with tumors that have spread and those with brain involvement, focusing on response rates and survival outcomes. The study involves oral doses of repotrectinib. Phase 1 includes dose escalation to determine dose-limiting toxicities, maximum tolerated dose, and recommended dose for Phase 2. A sub-study also examines drug interactions with midazolam. In Phase 2, participants are assigned to one of six groups based on their tumor type and prior treatments, including different lines of targeted therapy and chemotherapy. Treatments continue according to protocol with regular monitoring. Participants will have measurable tumors confirmed by imaging reviewed centrally. They undergo physical exams, lab tests, and safety assessments throughout the study. Researchers measure response rates, duration of response, progression-free survival, overall survival, and clinical benefit over several years. The study monitors drug levels in blood and evaluates safety closely. Participation may last years with follow-up to assess long-term outcomes and effects on brain metastases.

Researchers are evaluating the efficacy of venetoclax in adults with relapsed or refractory Chronic Lymphocytic Leukemia CLL or Small Lymphocytic Lymphoma SLL. This Phase 2, open-label, multicenter study focuses on two groups those with 17p deletion Cohort 1 and those who have failed B-cell receptor signaling pathway inhibitor therapy and either failed or cannot receive chemoimmunotherapy regardless of 17p status Cohort 2. Participants in both cohorts will receive various doses of venetoclax tablets taken once daily. The study does not involve a placebo group and uses a non-randomized approach. Treatment is tailored based on the participants disease characteristics and prior therapy history. During the study, researchers will monitor participants closely, assessing overall response rate up to two years after enrollment ends. Secondary measures include complete response rate, duration of response, progression-free survival, event-free survival, time to progression, time to lymphocyte count reduction, and overall survival, with some measures tracked up to five years. Participants will undergo regular evaluations to measure treatment effects and safety throughout the study.

Psoriatic arthritis PsA is a chronic inflammatory condition that affects the joints and skin in people with psoriasis. This study aims to evaluate how well zasocitinib TAK-279 works in adults with active PsA who have not previously been treated with biologic disease-modifying antirheumatic drugs. The trial is a Phase 3, randomized, double-blind study comparing zasocitinib with an active comparator and placebo. Participants will be assigned to one of four groups zasocitinib Dose A once daily, zasocitinib Dose B once daily, an active comparator capsule twice daily, or placebo once daily for 16 weeks followed by switching to zasocitinib Dose A or B up to 52 weeks. Treatments are taken orally as tablets or capsules over a period of up to 60 weeks. During the study, participants will undergo regular assessments including joint counts, skin evaluations, and various disease activity measurements such as ACR20 and PASI-75 responses. Researchers will monitor changes from baseline in functional and quality of life scores, as well as safety and tolerability. Participants will be involved in visits throughout the treatment period to evaluate the effects and collect data on the disease and treatment responses.