Luo Yang Shi

Researchers are studying relapsed or refractory multiple myeloma in adults who have already received treatment with lenalidomide and a proteasome inhibitor but whose disease has progressed. The study aims to evaluate the effects of adding SG301 injection to the standard treatment of pomalidomide and dexamethasone. This is a randomized, placebo-controlled, double-blind, multicenter phase III clinical trial. The study has two stages. Stage 1 is to find the right dose of SG301 combined with pomalidomide and dexamethasone. Stage 2 randomly assigns participants to receive either SG301 injection plus pomalidomide and dexamethasone or a placebo plus the same drugs. SG301 and its placebo are given by intravenous infusion weekly for 8 weeks, then every 2 weeks. Pomalidomide capsules are taken orally once daily on days 1 to 21 of each 28-day cycle. Dexamethasone is taken orally or by infusion on days 1, 8, 15, and 22, with dose adjusted for low body weight. Participants continue treatment until their disease progresses, unacceptable side effects occur, or other stopping criteria are met. Researchers will monitor side effects, drug levels in the body, immune response, and treatment effects including progression-free survival and overall survival for up to about 4 years. The study includes regular assessments every 4 weeks initially, then every 8 weeks, with safety followed for about 30 days after treatment ends.

Researchers are evaluating a study medicine called MK-1045 in adults with systemic lupus erythematosus SLE or rheumatoid arthritis RA. The main goal is to learn about the safety and tolerability of MK-1045 when given at different dose levels. This is a phase 1 clinical trial focused on treatment and led by Merck Sharp & Dohme LLC. Participants will receive MK-1045 through intravenous infusion. The study has three parts Part 1 involves single doses at various levels, Part 2 includes three step-up doses over three weeks as prime, step-up, and target doses, and Part 3 offers optional dose expansion with similar dosing. This sequential study uses randomized allocation without masking. During the study, participants will be monitored for adverse events and treatment discontinuations up to approximately 52 weeks depending on the study part. Researchers will also measure how the drug behaves in the body and its effect on peripheral B cell counts. Participants will have regular assessments including safety and pharmacokinetic evaluations throughout the study period, which runs up to July 2029.

Researchers are evaluating the effectiveness and safety of TQB2102 for injection compared to a standard chemotherapy regimen called TCbHP in patients with HER2-positive breast cancer. This phase III, randomized, open-label, multi-center study focuses on neoadjuvant treatment, which is therapy given before surgery. The study aims to measure the total pathological complete response and other outcomes such as event-free survival and overall survival. Participants receive either TQB2102 for injection at 6 mgkg by intravenous infusion every 3 weeks for 8 cycles or a combination of Trastuzumab, Pertuzumab, Docetaxel, and Carboplatin given intravenously every 3 weeks for 6 cycles. The study monitors participants throughout the treatment period and collects data on tumor response and side effects. During the study, participants will undergo assessments including tumor response evaluations by independent review and investigators, safety monitoring for adverse events, and laboratory tests. Follow-up will continue for up to 50 months after the start of the study to observe long-term outcomes. Participants are expected to comply with contraceptive use requirements and attend all scheduled visits for treatment and evaluations.

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 evaluating the efficacy and safety of enicepatide, a dual GLP-1GIP receptor agonist, at multiple doses compared with placebo for weight management in adults with obesity or overweight and type 2 diabetes mellitus T2DM. This Phase III study aims to better understand how enicepatide affects body weight and other health measures in this population. Participants will be randomly assigned to receive either placebo or one of three dosing regimens of enicepatide, administered once weekly using an integrated drug-device combination product. The study lasts for 72 weeks, during which participants will self-administer the study drug or receive injections from a trained individual if needed. Throughout the study, participants will undergo various assessments including body weight, hemoglobin A1c, waist circumference, fasting glucose and insulin, cholesterol levels, blood pressure, and quality of life questionnaires. Safety will be monitored through adverse event reporting and specific rating scales. This comprehensive evaluation will help determine the effects of enicepatide on weight and diabetes management over the study period.

Researchers are evaluating the effects of enicepatide, a dual GLP-1GIP receptor agonist, at multiple doses compared with placebo for weight management in adults with obesity or overweight who do not have Type 2 diabetes. This Phase III, randomized, double-blind study aims to assess both the efficacy and safety of once-weekly enicepatide in this population, addressing weight-related comorbidities such as prediabetes, hypertension, and cardiovascular conditions. Participants will be randomly assigned to receive either placebo or one of three enicepatide dosing regimens, administered once weekly via an integrated drug-device combination product. The treatment phase lasts through 72 weeks, during which changes in body weight and other health measures are monitored. The study includes multiple assessments to track body weight percentage change, waist circumference, fasting glucose and insulin levels, lipid profiles, blood pressure, and quality of life measures. Throughout the study, participants will undergo regular evaluations including physical examinations, laboratory tests, and questionnaires related to physical functioning and urinary incontinence. Researchers will monitor adverse events, patient-reported health questionnaires, and biomarkers at baseline and weekly intervals through week 72. This long-term follow-up allows for a comprehensive assessment of treatment effects and safety in participants managing obesity or overweight without Type 2 diabetes.

Researchers are evaluating the safety and tolerability of AWT020 alone and in combination with other antitumor therapies in patients with advanced cancers such as non-small cell lung cancer, colorectal cancer, renal cell carcinoma, melanoma, and other solid tumors. This phase I clinical study aims to assess these treatments in patients who have failed or are intolerant to standard therapies or have no standard treatment options. The study also explores pharmacokinetics and efficacy outcomes. Participants receive AWT020 either alone or combined with drugs including Taxol, Cisplatin or Carboplatin, Pemetrexed, Oxaliplatin, Capecitabine, Bevacizumab, or Renvastinib. Dosing schedules vary by drug, for example, Taxol is given every three weeks at 135-175 mgm, while AWT020 is administered intravenously every two or three weeks. The study includes single-agent dose escalation and expansion phases, as well as combination treatment phases, tailored to specific cancer types and prior treatment histories. During the study, participants undergo regular monitoring for dose-limiting toxicities, adverse events, and serious adverse events for up to 12 months. Pharmacokinetics and immunogenicity are evaluated for up to 24 months, while response rates, duration of response, disease control, progression-free survival, and overall survival are assessed up to approximately 32 months. Patients have scheduled visits for treatment administration and safety assessments, with adherence to contraception requirements for fertile participants. The total study duration extends until April 2028.

Researchers are evaluating TQB2102 for injection, a new antibody-coupled drug that targets two different parts of the HER2 protein on tumor cells. This study focuses on patients with unresectable locally advanced, recurrent, or metastatic HER2-positive gastroesophageal adenocarcinoma. The trial aims to assess the effectiveness and safety of TQB2102 combined with benmelstobart or penpulimab, with or without chemotherapy, in this patient group. This is a Phase II randomized study sponsored by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. Participants receive TQB2102 for injection and either benmelstobart or penpulimab, both given intravenously every three weeks. Chemotherapy is taken orally from Day 1 to Day 15 in each 21-day treatment cycle. There are three study groups, each involving different combinations and doses of TQB2102, benmelstobart, penpulimab, and chemotherapy. Treatment continues through multiple cycles as determined by the study protocol. During the study, participants undergo regular assessments including scans and tests to measure tumor response and disease progression. Researchers monitor outcomes like the objective response rate, progression-free survival, duration of response, overall survival, and any adverse events. The study includes follow-up periods to track safety and effectiveness, with an average observation of up to three years. Participants are closely monitored throughout the treatment and follow-up phases for their health and response to therapy.

Researchers are evaluating the combination of LBL-024 with other drugs for treating patients with advanced non-small cell lung cancer NSCLC in this open-label, multicenter phase II clinical trial. The study aims to assess the efficacy and safety of LBL-024 combined with various chemotherapy drugs. It plans to enroll up to 230 participants who have advanced solid tumors and measurable lesions. The trial consists of four cohorts, each including a safety run-in period where a small group receives LBL-024 combined with different drugs such as docetaxel, bevacizumab, pemetrexed, carboplatin, and paclitaxel through intravenous infusion. After a 21-day safety observation, researchers evaluate tolerability before continuing enrollment and extension treatments. Some cohorts include maintenance treatment phases with LBL-024 alone or combined with other drugs. Participants will undergo treatment and follow-up visits to monitor response and safety. Researchers will assess outcomes including objective response rate, disease control rate, duration of response, drug concentration levels, and immunogenicity. The study involves regular laboratory tests, physical assessments, and evaluation of measurable tumor lesions. Participation lasts through the treatment and a 28-day follow-up after stopping the study drug or before new anti-tumor therapy starts.

Researchers are evaluating the safety and effectiveness of a combination treatment using LBL-024 with etoposide and platinum drugs in people with advanced neuroendocrine carcinoma NEC. This study is an open-label, multicenter phase IbII trial designed to explore new treatment options for patients who have not received prior systemic therapy for NEC. The study aims to carefully assess how well patients respond to this combination and to find the best dose for further use. The trial has two parts phase Ib focuses on finding a safe and tolerable dose of LBL-024 combined with etoposide and platinum cisplatin or carboplatin using a dose-escalation method. Phase II then optimizes the dose and expands the study to more patients to confirm the recommended dose for future research. Participants are randomly assigned to receive either LBL-024 with etoposide and carboplatincisplatin or a comparator group receiving atezolizumab with etoposide and carboplatin. All treatments are given by intravenous infusion. Participants will undergo regular assessments including tumor measurements according to RECIST 1.1 criteria, monitoring of drug levels and immune responses, and tracking any side effects or serious events. The main outcomes measured include objective response rate, progression-free survival, dose-limiting toxicities, and safety events over a follow-up period after treatment ends. The study plans to enroll 178 patients aged 18 to 75 years and will continue through March 2027, with careful safety monitoring throughout.