Dong Guan Shi

This research aims to evaluate the effects of litifilimab (BIIB059), a monoclonal antibody, in adults with active subacute or chronic cutaneous lupus erythematosus (CLE), with or without systemic lupus erythematosus (SLE). Participants have active skin symptoms of CLE that have not improved with antimalarial therapy or had difficulties continuing that treatment. The study focuses on reducing skin disease activity using several scores including CLA-IGA-R and CLASI, while also assessing safety, immune response, and quality of life. Participants will be randomly assigned to receive either litifilimab or a placebo injection under the skin every four weeks during a 24-week double-blind period where neither participants nor researchers know which treatment is given. After this, all participants will receive litifilimab injections every four weeks for an additional 28 weeks. Those who complete the treatment may join a long-term extension study or enter a follow-up safety period lasting up to 24 weeks. Total participation may last up to 80 weeks. Throughout the study, researchers will monitor skin disease activity using the CLA-IGA-R erythema score and the CLASI-A activity score to see how many participants improve. They will also assess safety, tolerability, immune system effects, and participants' quality of life using questionnaires. These evaluations occur regularly during both treatment periods and follow-up to understand the impact of litifilimab on CLE symptoms and overall health.

Researchers are evaluating TQB6411 for injection, an antibody-drug conjugate (ADC) designed to treat advanced malignant tumors by targeting EGFR and c-Met on tumor cells. This drug binds to these receptors to block their signaling pathways, delivering toxins that cause DNA damage and cell death. The trial is a Phase I clinical study assessing the tolerance, pharmacokinetics, and preliminary efficacy of TQB6411 in patients with advanced cancers. Participants will receive TQB6411 administered intravenously. The antibody portion targets tumor cells expressing EGFR and c-Met, leading to internalization and toxin release inside the cells. This process aims to damage and kill tumor cells. The study includes dose escalation to determine the maximum tolerated dose and a dose expansion phase for specific tumor types such as advanced non-small cell lung cancer, metastatic colon cancer, esophageal squamous cell carcinoma, and nasopharyngeal carcinoma. During the study, participants will undergo various assessments including monitoring for dose-limiting toxicities, adverse events, and determination of the recommended Phase II dose over up to 24 months. Safety, pharmacokinetics, and tumor response evaluations will be conducted, alongside laboratory tests and tumor tissue analyses. The study requires compliance with contraception guidelines and includes follow-up for treatment effects and safety throughout the treatment period.

This study is an open-label phase II clinical study to explore the reasonable dosage and to evaluate the efficacy, safety and tolerability of HLX43 (Anti-PD-L1 ADC) in patients with recurrent/metastatic Nasopharyngeal Carcinoma (NPC) who failed or are intolerant to second-line therapy. In this study, eligible subjects will be randomized at 1:1:1 ratio, and the patients will be administered with HLX43 at three different doses via intravenous infusion.

Researchers are evaluating the real-world effectiveness of Repatha® combined with standard of care (SOC) compared to SOC alone in reducing major cardiovascular events. The study focuses on people with established atherosclerotic cardiovascular disease (ASCVD) who are treated according to local clinical practice. The goal is to see how these treatments affect the risk of cardiovascular death, heart attacks, stroke, hospitalization for unstable angina, or coronary revascularization. Participants will either be prescribed Repatha® in addition to their existing SOC treatment or continue with SOC alone. The study follows these participants over time to observe outcomes. Treatments are given according to local guidelines and approved labels, reflecting real-world medical care. During the study, researchers will monitor participants for the time until the first occurrence of any major cardiovascular event listed above, for up to 72 months. Participants will undergo regular assessments to track their health status and treatment effects. Safety and effectiveness are observed through ongoing real-world data collection in this prospective, observational study.

Researchers are evaluating the anti-tumor activity of amivantamab combined with pembrolizumab and carboplatin compared to pembrolizumab, 5-fluorouracil (5-FU), and platinum therapy (carboplatin or cisplatin) in participants with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). This trial focuses on participants who have not received prior systemic treatment in the recurrent/metastatic setting. HNSCC is a type of cancer affecting the outer tissue layer of the mouth and throat and other head and neck regions. Participants will receive either amivantamab added to pembrolizumab and carboplatin or the standard care regimen of pembrolizumab, 5-FU, and a platinum agent (carboplatin or cisplatin). 5-FU will be given as an infusion over a 4-day period. The study is a phase 3, randomized, open-label, multicenter trial comparing these treatment combinations. During the study, researchers will monitor overall survival and the objective response rate using standard tumor evaluation criteria for up to about 3 years and 7 months. Participants will undergo assessments to measure disease response, including imaging and other evaluations, to track how well the treatments work. Safety and side effects will also be monitored throughout the trial period.

Researchers are evaluating the safety, tolerability, pharmacokinetic properties, and preliminary effectiveness of BL-M07D1 in patients with locally advanced or metastatic HER2-positive or low-expression breast cancer and other solid tumors. This Phase I clinical study aims to determine the dose-limiting toxicity, maximum tolerated dose, and recommended dose for Phase II studies of BL-M07D1. The trial focuses on patients whose tumors have failed standard therapy or are not eligible for it, including those with specific HER2 expression levels confirmed by pathology. Participants will receive BL-M07D1 administered through intravenous infusion. The study includes two parts: Phase Ia, where the safety and tolerability are assessed to find the maximum tolerated dose, and Phase Ib, which further evaluates safety at the recommended dose from Phase Ia and establishes the recommended Phase II dose. Both phases monitor dosing and patient responses within 21 days after the first dose. During the study, patients will undergo various assessments including tumor tissue analysis, physical exams, and monitoring of organ function and adverse effects. Researchers will track safety measures like dose-limiting toxicity and maximum tolerated dose, as well as pharmacokinetic and immunogenicity profiles. The study requires participants to have measurable tumors and good performance status, with ongoing monitoring to evaluate treatment effects and safety throughout the trial period.

Researchers are evaluating the safety and effectiveness of Dostarlimab compared to a placebo in adults with locally advanced unresected Head and Neck Squamous Cell Carcinoma (HNSCC). This phase 3 randomized, double-blind, placebo-controlled study focuses on patients who have completed chemoradiation therapy with cisplatin and radiation and have no distant metastatic disease. The study requires confirmation of PD-L1 positive tumor status and specific testing for oropharyngeal carcinoma cases. Participants will receive either Dostarlimab or a placebo as an intravenous infusion following their chemoradiation treatment. The study monitors these treatments as sequential therapy to assess their impact on disease progression. Treatments are administered in a controlled, blinded manner to compare outcomes between the two groups effectively. During the study, participants will be followed for up to approximately five years to measure event-free survival, with evaluations conducted by blinded independent central review. Assessments will include monitoring for safety, disease status, and any adverse events throughout the study period. This long-term follow-up aims to provide comprehensive data on the effectiveness and safety of Dostarlimab as post-chemoradiation therapy in this patient population.

Researchers are evaluating whether adding JNJ-90301900 to standard concurrent platinum-based doublet chemotherapy with radiation therapy followed by consolidation immunotherapy can improve the objective response rate in participants with locally advanced and unresectable stage III non-small cell lung cancer. This phase 2, randomized, open-label study focuses on participants diagnosed recently with NSCLC and eligible for this combined treatment approach. Participants will receive JNJ-90301900 injected directly into tumors or lymph nodes alongside concurrent chemo/radiation therapy, which includes carboplatin and paclitaxel administered intravenously and radiation delivered by intensity modulated radiation therapy. Following this, consolidation immunotherapy with intravenous durvalumab will be given. The study evaluates this combined treatment sequence against standard care approaches. During the study, participants will undergo assessments including imaging to measure tumor response according to RECIST criteria, with the primary outcome being the objective response rate over up to 2 years and 2 months. Researchers will monitor safety and treatment effects throughout, ensuring participants meet performance status criteria and have lesions suitable for injections and radiation. The study involves ongoing evaluations guided by independent central review.

Researchers are evaluating new combination treatments for people with locally advanced or metastatic non-small cell lung cancer (NSCLC) in this Phase II, multi-center, open-label study. The trial includes several sub-studies focusing on different groups of NSCLC patients based on genetic and protein markers. The goal is to study the safety, tolerability, and early anti-tumor effects of these novel treatment combinations across about 80 centers worldwide in 10 countries. The study consists of three sub-studies: one testing rilvegostomig with or without ramucirumab in patients with high PD-L1 expression (50% or more) and no actionable genomic alterations; another testing rilvegostomig plus ramucirumab in patients with moderate PD-L1 expression (1-49%) and no actionable genomic alterations; and a third testing Dato-DXd with ramucirumab, with or without rilvegostomig, in later-line patients positive for actionable genomic alterations who have progressed on prior targeted therapy. Treatments are given by intravenous infusion. Each sub-study may have two parts: a safety run-in phase and a dose expansion phase. Participants will be involved for around 3 years, during which researchers will monitor adverse events and serious adverse events to assess safety. They will also evaluate the objective response rate to measure anti-tumor activity. Participants must have adequate organ function, a certain performance status, and measurable tumors. Regular assessments include tumor tissue analysis and monitoring of health status. The study excludes those with certain infections, uncontrolled diseases, or prior therapies that could interfere with the trial.

This is a multicenter, open-label, Phase Ib/II study conducted in China to evaluate the safety, efficacy, and pharmacokinetic (PK) characteristics of YL201 combined with Toripalimab (doublet regimen) or YL201 combined with Toripalimab and Cisplatin (triplet regimen) in subjects with recurrent or metastatic nasopharyngeal carcinoma.