Dong Guan Shi

Researchers are evaluating BLU-5937, an oral drug, in adults with refractory chronic cough, including unexplained chronic cough, in a randomized, double-blind, placebo-controlled Phase 3 study. The main goal is to assess how BLU-5937 affects 24-hour cough frequency over 24 weeks. This study also monitors safety by tracking adverse events and changes in various health parameters during the treatment period. Participants are randomly assigned to one of three groups BLU-5937 25 mg twice daily, BLU-5937 50 mg twice daily, or a matching placebo taken twice daily. The treatment lasts for 24 weeks, and participants receive their assigned oral medication regularly throughout this time. The study uses a parallel-arm design and includes an extension in China. During the study, participants undergo assessments including cough frequency measurement, vital signs, blood tests for hormones and chemistry, hematology, and ECGs at baseline and Week 24. Researchers also evaluate cough severity and quality of life using questionnaires. Safety is closely monitored by recording adverse events, treatment discontinuations, and laboratory changes. The total participation duration is 24 weeks, with follow-up assessments at specified intervals.

Researchers are evaluating TQB6411 injection, an antibody-conjugated drug that targets EGFR and c-Met proteins on tumor cells, in people with advanced malignant tumors. The study aims to assess how well patients tolerate the treatment, understand how the drug moves through the body, and observe early signs of its effects. This phase I clinical trial focuses on patients who have advanced cancer and have not responded to or cannot tolerate standard treatments. TQB6411 is given by intravenous injection every three weeks, with doses ranging from 0.8 mgkg to 8 mgkg at the start of each treatment cycle. The antibody in TQB6411 binds to cancer cells to block important growth signals, and then releases toxins inside the cells to cause DNA damage and cell death. The study includes a dose escalation stage to find the maximum tolerated dose and a dose expansion stage for specific tumor types such as advanced non-small cell lung cancer and metastatic colon cancer. Participants will have regular blood tests and tumor imaging to monitor safety and treatment effects for up to 24 months. Researchers will track dose-limiting toxicities, adverse events, drug levels in the blood, tumor response rates, and survival outcomes. Women of childbearing potential must use effective contraception during and for six months after the study. The trial includes careful monitoring to assess the bodys reaction to the drug and to gather information for future studies.

Researchers are evaluating the dose-effect relationship of TQH3906 capsules compared to placebo in treating active Psoriatic Arthritis PsA. This Phase II, randomized, double-blind, placebo- and active drug-controlled clinical trial aims to measure the proportion of participants achieving a 20% improvement in arthritis symptoms by Week 12, using the American College of Rheumatology ACR20 criteria as the primary endpoint. Participants are randomly assigned to receive one of several oral treatments daily from Day 1 to Day 85 either 24 mg or 16 mg of TQH3906 capsules, placebo capsules matching TQH3906, or 5 mg tofacitinib citrate tablets. The treatments are administered in the morning while fasting, with tofacitinib also taken at bedtime. This study evaluates efficacy and safety across these groups over 12 weeks of treatment. During the study, participants are assessed at multiple timepoints for improvements in arthritis symptoms ACR20, ACR50, ACR70 and psoriasis severity PASI 75 and PASI 90. Blood samples are collected to evaluate drug levels and immune markers at baseline and Weeks 2, 4, 8, and 12. Safety is monitored continuously through adverse event reporting up to 28 days after the last dose. The total study duration per participant is approximately 12 weeks of treatment plus follow-up.

Researchers are evaluating HLX43, an anti-PD-L1 antibody linked to a potent DNA topoisomerase I inhibitor, in patients with recurrent or metastatic Nasopharyngeal Carcinoma NPC who have not responded to or cannot tolerate second-line therapies. This phase II open-label study aims to find the appropriate dose and assess the safety, tolerability, and effectiveness of HLX43 in this patient group. Participants are randomly assigned to one of three HLX43 dose groups. The drug is given through intravenous infusion every three weeks. Treatment continues as long as patients tolerate it well and the disease remains controlled, stopping only if the disease progresses, intolerable side effects occur, another anti-cancer therapy is started, consent is withdrawn, or death occurs. During the study, patients will undergo regular assessments including tumor evaluations to measure response and progression, safety monitoring for adverse effects, and tissue sample collection for PD-L1 expression analysis. The main outcomes measured are the overall response rate within 24 weeks and progression-free survival up to 12 months. Patients will be followed for safety and survival for up to 18 months after treatment starts.

Researchers are evaluating the real-world effectiveness of Repatha combined with standard of care SOC compared to SOC alone in Chinese adults with established atherosclerotic cardiovascular disease ASCVD. The study focuses on the risk of major cardiovascular events such as cardiovascular death, heart attack, stroke, hospitalization for unstable angina, or coronary revascularization. This observational study aims to understand how these treatments work when used according to local clinical practice. Participants are divided into two groups based on treatment decisions made independently of the study enrollment those receiving Repatha with SOC and those receiving SOC alone. The study observes these participants over a period of up to 72 months to assess outcomes. Treatment choices follow local guidelines and approved labels, ensuring minimal impact on routine care. During the study, participants undergo regular monitoring for cardiovascular events and changes in cholesterol levels, including low-density lipoprotein cholesterol LDL-C. Researchers also track adverse events and reactions throughout the follow-up period. Participants remain under usual care, and data collection occurs alongside routine clinical visits, with a total participation time of up to six years.

This trial is for adults with recurrent or metastatic head and neck squamous cell carcinoma HNSCC that has not been treated with systemic therapy before. The study compares the anti-tumor effects of amivantamab combined with pembrolizumab and carboplatin against pembrolizumab with 5-fluorouracil and platinum therapy carboplatin or cisplatin. Participants have HNSCC in the oral cavity, oropharynx, hypopharynx, or larynx but not nasopharynx or unknown primary tumor sites, and HPV status is considered for oropharynx cases. Participants are randomly assigned to one of two groups. One group receives pembrolizumab, amivantamab, and carboplatin, while the other receives pembrolizumab, 5-fluorouracil given as a 4-day infusion, and carboplatin or cisplatin. Treatments are given according to standard protocols for these drugs. The study is open-label and conducted across multiple centers. During the trial, participants will be monitored for overall survival and tumor response using established criteria up to about 3 years and 7 months. Additional assessments include progression-free survival, duration of response, quality of life questionnaires specific to head and neck cancer, and safety evaluations through adverse event and lab test monitoring. Blood samples will check amivantamab levels and antibodies. Participation involves regular visits for treatment and assessments throughout the study period.

Researchers are studying BL-M07D1, an intravenous drug, to evaluate its safety, tolerability, and preliminary effectiveness in patients with locally advanced or metastatic HER2-positive or low-expression breast cancer and other solid tumors. This phase I trial aims to identify the dose-limiting toxicity, maximum tolerated dose, and the recommended dose for future studies. The study includes patients who have failed or are not eligible for standard therapies. Participants receive BL-M07D1 through intravenous infusion every three weeks during the first treatment cycle. Those who show clinical benefit may continue receiving additional cycles until disease progression, intolerable side effects, or other reasons cause treatment to stop. The study proceeds through phase Ia to phase Ib to determine safe dosing and monitor the drugs pharmacokinetics and immunogenicity. During the trial, participants will undergo assessments including tumor tissue analysis, imaging to measure lesions, and health evaluations such as heart function and blood tests. Researchers will track side effects, immune response to the drug, and tumor response over approximately 24 months. The primary outcomes focus on safety and dose recommendations within 21 days after the first dose, while secondary outcomes include longer-term measures like disease control, response duration, and progression-free survival.

Researchers are evaluating Dostarlimab compared to a placebo in adults with locally advanced unresected Head and Neck Squamous Cell Carcinoma HNSCC. This phase 3 trial aims to assess the safety and effectiveness of Dostarlimab as a sequential therapy following chemoradiation treatment in participants with this type of cancer. Participants are randomly assigned to receive either Dostarlimab or a placebo, both given as intravenous infusions. The study is double-blind, meaning neither the participants nor the researchers know which treatment is being given. The treatments follow completion of chemoradiation with cisplatin and radiotherapy intended to cure the cancer. During the study, participants will be monitored for up to approximately 5 years. Researchers will evaluate event-free survival and overall survival, with safety assessments including treatment-emergent adverse events and laboratory tests. Blood samples will be taken to measure drug levels and immune responses. This long-term follow-up will help understand the effects and safety of Dostarlimab after chemoradiation therapy.

Researchers are evaluating whether adding the investigational drug JNJ-90301900 to standard concurrent platinum-based doublet chemotherapy with radiation therapy cCRT, followed by consolidation immunotherapy cIT with durvalumab, can improve the objective response rate in participants with locally advanced and unresectable stage III non-small cell lung cancer NSCLC. This Phase 2 study aims to compare the safety and efficacy of JNJ-90301900 in combination with cCRT and cIT against cCRT and cIT alone. The study is sponsored by Johnson & Johnson Enterprise Innovation Inc. Participants will be randomly assigned to one of three groups two experimental arms where JNJ-90301900 is injected intratumorally andor intranodally at different percentages of gross tumor volume 22% or 33% along with cCRT and followed by cIT, and a control arm receiving cCRT followed by cIT without JNJ-90301900. Chemotherapy drugs include carboplatin and paclitaxel administered intravenously, radiation therapy is delivered by intensity modulated radiation therapy IMRT, and consolidation immunotherapy is given as durvalumab through intravenous infusion. During the study, participants will undergo regular assessments to monitor tumor response using objective response rate evaluations up to 2 years and 2 months. Other measures include disease control rate, progression-free survival, duration of response, and safety evaluations such as adverse event monitoring, laboratory tests, physical exams, and vital signs. The total participation duration spans treatment and follow-up to assess long-term outcomes and safety of the treatment combinations.

Researchers are evaluating nipocalimab compared to a placebo in adults with moderate to severe systemic lupus erythematosus SLE, a chronic disease where the immune system attacks healthy tissues causing swelling and redness in various organs. This Phase 3 study aims to understand how well nipocalimab works in treating SLE symptoms and disease activity. Participants will receive either nipocalimab or a placebo alongside standard care treatments during a double-blind treatment period lasting up to 52 weeks. After this period, eligible participants from both groups may enter an open-label long-term extension phase to continue nipocalimab treatment until Week 156 or until discontinuation. Throughout the study, participants will undergo assessments including measurement of disease activity, joint pain, fatigue, and flare status. Researchers will monitor responses such as the SLE Responder Index at Week 52, and track safety and treatment adherence. The total participation duration may extend up to approximately three years including the extension phase.