Lang Fang Shi

Researchers are investigating the safety, tolerability, how the body processes the drug, and early anti-cancer effects of a new oral medication called JAB-23E73. This drug is designed for adult patients with advanced solid tumors that have changes in the KRAS gene, either mutations or increased copies. The trial is divided into two main parts: an initial dose escalation phase to find the best dose and a following dose expansion phase to further study effectiveness and safety.

Researchers are investigating a phase Ib/II clinical trial of ATG-022 combined with pembrolizumab, with or without chemotherapy, in participants with Claudin (CLDN) 18.2-positive, HER2-negative, PD-L1 positive, unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma. The study includes participants who have either progressed after prior systemic therapy or who have not received prior systemic therapy. The trial aims to evaluate the safety, dosing, and efficacy of these treatment combinations within this specific patient population. The study involves two main treatment groups: one receiving ATG-022 plus pembrolizumab (A+P), and the other receiving ATG-022 plus pembrolizumab combined with chemotherapy using the CAPOX regimen (A+P+C). ATG-022 is administered at 1.8 mg/kg every 21 days, pembrolizumab at 20 mg every 21 days, and CAPOX chemotherapy includes capecitabine and oxaliplatin given every 21 days for eight cycles. The trial starts with the A+P treatment phase, and based on its clinical data, the A+P+C treatment phase may then be initiated. Participants will undergo tumor tissue testing for CLDN 18.2 and PD-L1 expression before enrollment and must have at least one measurable lesion. Researchers will monitor adverse events and serious adverse events up to 12 months after the last participant is enrolled, dose-limiting toxicities within 21 days, and determine the recommended phase 2 dose. The study includes assessments of safety, treatment response, and tolerability throughout the treatment and follow-up periods.

Researchers are evaluating the effect of a triple therapy inhaler called BGF MDI containing budesonide, glycopyrronium, and formoterol fumarate compared with a dual therapy inhaler called GFF MDI containing glycopyrronium and formoterol fumarate in people with Chronic Obstructive Pulmonary Disease (COPD) who have a higher risk of heart and lung problems. This Phase III randomized, double-blind, parallel group study takes place at multiple centers and focuses on cardiopulmonary outcomes in these patients. Participants receive either the BGF MDI 320/14.4/9.6 micrograms twice daily or the GFF MDI 14.4/9.6 micrograms twice daily. The treatments are inhaled using metered dose inhalers. The study compares these two therapies over time to see how they affect the time until the first severe heart or lung event occurs. The study design ensures that neither participants nor researchers know which treatment is given to reduce bias. During the study, participants will have regular visits to the study site or virtual visits to complete assessments. Researchers will monitor lung function, symptoms, and blood tests, including blood eosinophil counts and COPD assessment test scores. The main outcome measured is the time to the first severe cardiac or COPD event, with follow-up lasting up to three years. Safety and adherence to treatment will also be closely observed throughout the study period.

Researchers are evaluating the safety and effectiveness of 9MW1911 in people with Chronic Obstructive Pulmonary Disease (COPD) through a Phase II, multicenter, double-blind, randomized, placebo-controlled clinical trial. The study focuses on patients aged 40 to 75 years who have a history of moderate to severe COPD exacerbations and moderate-to-severe COPD lung function impairment. This trial aims to compare 9MW1911 to a placebo to better understand its impact on COPD symptoms and exacerbations. Participants will be assigned to receive either intravenous 9MW1911 or a placebo every 28 days. The treatment period lasts 52 weeks, during which the study drug is administered monthly. The trial includes careful monitoring and evaluation of the participants' lung function and health status throughout this time to assess the effects of the treatment. During the study, participants will undergo various assessments including lung function tests and monitoring for COPD flare-ups or exacerbations. The primary outcome measured is the annual rate of moderate to severe acute COPD exacerbations over 52 weeks. Safety evaluations and regular health checks will also be conducted to ensure participant well-being. The total duration of participation in the trial is one year, providing comprehensive data on treatment effects and safety.

Researchers are evaluating the safety, effectiveness, and best dose of telisotuzumab adizutecan (ABBV-400) combined with fluorouracil, leucovorin, and the PD1 inhibitor budigalimab for adults with locally advanced unresectable or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma. This phase 2 study involves about 180 participants worldwide and aims to understand adverse events and disease activity changes with this combination treatment. The study has two stages. The first stage gradually increases doses of ABBV-400 in the combination until a tolerable and effective dose is reached. In the second stage, participants are randomly assigned to receive either budigalimab plus FOLFOX (fluorouracil, leucovorin, and oxaliplatin) or the combination including two optimized ABBV-400 doses. All treatments are given intravenously. The study will last about six years. Participants will attend regular visits at a hospital or clinic where medical exams, blood tests, questionnaires, and side effect monitoring will be conducted frequently. Researchers will measure progression-free survival and the percentage of participants showing a response to treatment. The study involves close monitoring of treatment effects and safety throughout its duration.

Researchers are evaluating the safety, tolerability, and immune response of a recombinant respiratory syncytial virus (RSV) vaccine called SCTV02 in adults aged 18 years and older. This randomized, double-blind, placebo-controlled Phase 1/2 trial aims to understand how well the vaccine is tolerated and how it stimulates the immune system against RSV. Participants will receive a single dose of either the SCTV02 vaccine or a placebo on Day 0. Three different dose levels of SCTV02 will be tested. The study will monitor participants for any adverse events within 7 days after vaccination and collect data on any unsolicited adverse events up to 30 days post-vaccination. The immune response will be assessed by measuring neutralizing antibodies against RSV subtypes A and B at multiple time points: 14, 30, 90, 180, and 365 days after vaccination, along with T cell response at 30 days. During the study, participants will be asked to complete diary cards to record any symptoms or side effects. Researchers will evaluate the occurrence and severity of adverse events and measure immune responses through blood tests. The total study duration includes follow-up visits up to one year to monitor long-term safety and immune response. The primary outcomes focus on adverse events within the first week post-vaccination and antibody levels 30 days after vaccination.

Researchers are studying the effectiveness, safety, and tolerability of ponsegromab combined with standard chemotherapy compared to chemotherapy with placebo in adults who have cachexia and metastatic pancreatic ductal adenocarcinoma. This Phase 2b/3 study includes participants who have already completed initial chemotherapy cycles and aims to evaluate ponsegromab as a first-line treatment option for this condition. The study includes a randomized, double-blind design conducted across multiple centers and countries. Participants will receive either one of two doses of ponsegromab or a placebo, both given alongside standard chemotherapy regimens such as nab-paclitaxel plus gemcitabine or FOLFIRINOX. The study intervention is administered subcutaneously every four weeks. After Phase 2b, one ponsegromab dose will be selected for Phase 3, and participants may continue or switch doses accordingly while maintaining blinding. An optional open-label extension allows participants to receive ponsegromab for up to 12 months after the double-blind study period. During the study, participants will undergo tumor assessments every 6 to 8 weeks by independent radiologists. Researchers will measure body weight changes and anorexia symptoms over 12 weeks to assess treatment impact. The study also includes a caregiver sub-study to explore the quality of life and well-being of primary caregivers. Treatment continues until discontinuation, withdrawal, death, or study completion based on overall survival events.

Researchers are evaluating post-operation adjuvant therapies for early stage breast cancer using a strategy based on minimal residual disease (MRD) testing. This prospective, multi-center, open-label cohort study focuses on 3 years disease-free survival as the primary goal. About 100 patients with triple-negative breast cancer (TNBC), 100 with HER2-positive breast cancer, and 100 with estrogen receptor-positive (ER+) breast cancer will be enrolled. The MRD strategy aims to customize treatment intensity based on clinical risk and MRD test results after surgery. The study uses tumor-informed personalized panels to test MRD. Patients classified as high risk or who test positive for MRD after surgery receive intensive adjuvant therapies tailored to their breast cancer subtype, including chemotherapy, targeted therapy, or endocrine therapy. Those with low clinical risk and negative MRD receive standard adjuvant therapies. Treatments and regimens are adjusted every 3 months according to changes in MRD status, with options to change additional therapies if MRD remains positive. Participants will be followed for up to 3 years after surgery, with regular assessments every 3 months to monitor MRD status and adjust therapies accordingly. Researchers will measure disease-free survival from the date of surgery until cancer progression or death. Safety and organ function will be monitored throughout the study. The total involvement includes surgery, systemic therapy, MRD testing, and follow-up visits to evaluate treatment effectiveness and patient outcomes.

Researchers are evaluating how well glofitamab-based therapy works and how safe it is for Chinese adults with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL) who have already undergone one line of systemic treatment. This observational study focuses on second-line therapy to better understand treatment outcomes in a real-world setting. Participants will receive glofitamab as part of their cancer treatment regimen, but no additional interventions will be given by the study team. Treatment is based on the physician’s decision and real-world use, with some participants having started glofitamab within three months before joining the study. During the study, researchers will monitor participants for up to approximately four years to measure progression-free survival and assess treatment safety. Data will be collected through regular follow-ups to observe how participants respond to the therapy over time.

Researchers are enrolling patients experiencing stable chest pain who are suspected of having obstructive coronary artery disease. The study evaluates whether coronary computed tomography angiography (CCTA), analyzed with advanced software, can provide detailed anatomical, functional, and tissue information about the coronary arteries. The goal is to see if this imaging approach improves clinical management by reducing major adverse cardiovascular events and aiding better decisions about further tests and treatments. All participants undergo CCTA using established guidelines and local protocols. The imaging results are processed with different software tools to extract comprehensive information about the coronary arteries. This detailed evaluation aims to support clinical decisions regarding downstream investigations and therapeutic interventions for stable chest pain. During the study, researchers will monitor participants for up to 10 years to track major adverse cardiovascular events. Data from the imaging and follow-up outcomes will be used to assess how well CCTA-based evaluation helps in managing stable chest pain. The long-term observation will provide insight into the impact of this approach on patient care and cardiovascular health.