Luo Yang Shi

Researchers are evaluating the effects of adding SG301 injection to pomalidomide and dexamethasone in adults with relapsed or refractory multiple myeloma who have had at least one prior treatment including lenalidomide and a proteasome inhibitor. This phase III, randomized, placebo-controlled, double-blind study aims to compare SG301 combined with pomalidomide and dexamethasone against placebo combined with these drugs. The study includes two stages: a dose exploration phase to determine the recommended dose of SG301, followed by a randomized controlled phase to assess treatment outcomes. Participants will receive SG301 or placebo as an intravenous infusion weekly for 8 weeks, then every two weeks thereafter. All participants will take pomalidomide capsules orally at 4 mg once daily on days 1 through 21 of each 28-day cycle. Dexamethasone will be given orally or intravenously at 40 mg on days 1, 8, 15, and 22 of each 28-day cycle, with a reduced dose for participants with low body mass index. The study treatment continues through these cycles, with dosing and treatment monitored carefully. Participants will be monitored for adverse events from the first dose through about 30 days after the last dose, with follow-up lasting up to approximately 4 years. Disease progression and survival will be tracked regularly, with assessments every 4 weeks initially and then every 8 weeks after randomization. The study includes evaluations of organ function, disease status, and safety to gather comprehensive data on the treatments' impact and participant well-being throughout the trial period.

Researchers are conducting a phase III, randomized, open-label, multicenter clinical trial to evaluate the safety and effectiveness of TQB2102 for injection compared to the chemotherapy regimen TCbHP in the neoadjuvant treatment of patients with HER2-positive breast cancer. The study aims to assess key outcomes including the total physiological complete response (tpCR), breast pathological complete response (bpCR), overall response rate (ORR), event-free survival (EFS), invasive disease-free survival (IDFS), overall survival (OS), and adverse events (AEs). Participants will receive either TQB2102, a HER2 dual-antibody drug conjugate, or the TCbHP chemotherapy combination consisting of Trastuzumab, Pertuzumab, Docetaxel, and Carboplatin. Treatment is given before surgery as part of the neoadjuvant approach. The study compares these two treatment regimens to determine their relative effectiveness and safety in this setting. During the study, participants will be monitored for response to treatment and side effects over a period of up to 26 months from the start of the study. Evaluations by an Independent Review Committee will include measuring the rate of total physiological complete response. Additional assessments will track other clinical outcomes and adverse events. Participants must comply with study requirements, including surgery after neoadjuvant therapy if appropriate, and safety will be closely observed throughout the trial.

Researchers are evaluating tulisokibart as a potential treatment for radiographic axial spondyloarthritis (r-axSpA), a type of arthritis causing pain, stiffness, and inflammation in the spine and pelvis joints, visible on X-rays. This Phase 2b study aims to determine if different doses of tulisokibart improve symptoms better than a placebo, which looks like the study medicine but contains no active drug. The study has two main parts: a 16-week placebo-controlled period where participants receive either tulisokibart or placebo through subcutaneous injections, followed by a 124-week long-term extension divided into a 40-week main extension and an 84-week optional extension. This allows researchers to assess both the short-term and longer-term effects and safety of tulisokibart. Participants will be monitored for their response using the Assessment of Spondyloarthritis International Society (ASAS) 40 response at week 16 as the primary outcome. Throughout the study, researchers will evaluate disease activity and safety while tracking symptoms and any side effects. The total involvement spans up to 140 weeks, including both initial treatment and extension phases.

This phase I clinical trial is investigating the safety and tolerability of AWT020, both as a single treatment and combined with other antitumor therapies, in patients with advanced cancers. The study focuses on patients with advanced malignancies such as non-small cell lung cancer, colorectal cancer, renal cell carcinoma, melanoma, and other solid tumors. The goal is to understand how well patients tolerate AWT020 alone and in combination, as well as to assess its pharmacokinetics and potential efficacy. Participants may receive AWT020 intravenously every two or three weeks, either alone or combined with other cancer drugs including Taxol, Cisplatin, Carboplatin, Pemetrexed, Oxaliplatin, Capecitabine, Bevacizumab, and Renvastinib. These combination therapies follow specific dosing schedules, such as every three weeks or daily dosing for some drugs. The trial includes dose escalation and expansion phases to test different doses and combinations, tailored to patients' previous treatments and cancer types. Throughout the study, patients will be closely monitored for dose-limiting toxicities, adverse events, and serious adverse events for up to approximately 12 months after their first dose. Researchers will determine the maximum tolerated dose and recommend doses for future studies over a period extending up to about 32 months. Participants will undergo evaluations including physical exams, laboratory tests, and safety assessments to track treatment effects and overall well-being during the study period.

Researchers are evaluating the efficacy and safety of a new antibody-coupled drug called TQB2102 for injection in patients with unresectable locally advanced, recurrent, or metastatic HER2-positive gastroesophageal adenocarcinoma. This Phase II study focuses on how TQB2102 works in combination with Benmelstobart Injection or Penpulimab Injection, with or without chemotherapy, to target HER2 proteins on tumor cells and potentially improve treatment outcomes. The study aims to assess the Objective Response Rate (ORR) over about one year of participation. The treatments being studied include TQB2102 combined with Benmelstobart and chemotherapy or TQB2102 combined with Penpulimab and chemotherapy. TQB2102 is designed to bind more effectively to tumor cell HER2 proteins, while Benmelstobart and Penpulimab are antibodies that may help the immune system target cancer cells. Different dosing regimens of TQB2102 (6 mg or 7.5 mg) are being evaluated, and chemotherapy may be included depending on the treatment group. Participants will be monitored through regular evaluations during the study, which lasts approximately one year. Researchers will measure tumor response and safety outcomes, including lab tests and imaging to confirm measurable lesions according to RECIST 1.1 criteria. The study also involves reviewing previous PD-L1 expression test results or collecting tumor tissue for testing. Safety is closely observed, and participants must meet specific health criteria to join and continue in the trial.

Researchers are evaluating the safety and effectiveness of LBL-024 combined with other drugs in treating patients with advanced non-small cell lung cancer (NSCLC), a type of advanced solid tumor. This open-label, multicenter, phase II study includes four different patient groups to assess this combination therapy. The goal is to understand how well these treatments work together and their safety in this patient population. The study involves a safety run-in period for each group, where a small number of patients receive the LBL-024 combination to monitor tolerability over 21 days. Depending on the safety results, some groups will continue treatment with LBL-024 combined with other drugs such as pemetrexed, or LBL-024 alone for maintenance therapy. Patients are randomized into different arms to receive various combinations of intravenous infusions including LBL-024, docetaxel, bevacizumab, pemetrexed disodium, paclitaxel, and carboplatin. Participants will be closely monitored throughout the study for tumor response using established criteria and safety assessments. Researchers will track the objective response rate from the time patients consent through 28 days after stopping the study drug or before starting new anti-tumor treatment. The study will enroll up to 230 subjects aged 18 to 75 years and includes regular evaluations, laboratory tests, and follow-ups to ensure safety and measure treatment effects.

Researchers are evaluating the safety and effectiveness of LBL-024 combined with etoposide and platinum chemotherapy drugs as a first treatment for patients with advanced neuroendocrine carcinoma (NEC). This open-label, multicenter study includes two parts: a Phase Ib dose-escalation to find the best dose and a Phase II study to optimize and expand the dosing. The trial aims to determine the recommended Phase 2 dose by assessing safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy in patients who have not previously received systemic therapy. During Phase Ib, patients receive increasing doses of LBL-024 with etoposide and platinum (cisplatin or carboplatin) via intravenous infusion to evaluate safety. Phase II includes dose optimization in two dose groups to fully understand the dose-exposure-effect relationship. After confirming the recommended dose, a dose expansion phase will enroll more patients treated at this dose level to gather more efficacy data. This study plans to enroll a total of 178 patients across both phases. Participants will be closely monitored from the time they sign informed consent through follow-up periods after treatment withdrawal. Researchers will measure objective response rate, progression-free survival, dose-limiting toxicities during the first 3 weeks, adverse and serious adverse events up to 90 days after treatment ends, and determine the recommended Phase 2 dose. The study involves multiple visits for treatment administration, safety evaluations, and efficacy assessments to ensure comprehensive data collection throughout the trial.

Researchers are conducting a multicenter, randomized, double-blind, placebo-controlled phase II clinical trial to evaluate the efficacy and safety of TQH2929 injection in patients experiencing acute flare-ups of generalized pustular psoriasis (GPP). The study aims to provide evidence on how well TQH2929, a humanized monoclonal antibody, works in managing this severe skin condition. A total of 36 patients will participate in the trial. Participants will receive either TQH2929 injections or a placebo, with the placebo containing no active substance. The treatment is administered through injection, and all subjects will use either the study drug or placebo during the trial period. This setup allows researchers to compare outcomes between the two groups under controlled conditions. During the study, participants will be closely monitored through visits and procedures to assess treatment effects and safety. Researchers will measure outcomes such as the percentage of patients achieving a pustule score of zero after one week of treatment. Female participants of childbearing age must agree to use contraception during the study and for six months afterward. The trial will also include safety monitoring for infections, immune status, and other health factors over the course of participation.

Researchers are evaluating the effectiveness and safety of TQB6411 for Injection in adults with advanced lung cancer. This clinical trial is designed as a Phase Ib/II study to determine the recommended Phase II dosage and to observe the objective response rate over a period of up to six months. Participants must have confirmed lung cancer with measurable lesions and meet specific health and laboratory criteria to be eligible. The treatment involves administering TQB6411 for Injection every 21 days as a cycle. The study focuses on monitoring the drug’s safety and how well it works in treating advanced lung cancer. Participants will receive this treatment while being closely observed for any side effects or responses to the therapy. During the study, participants will undergo various assessments including laboratory tests, tumor tissue sampling for immunohistochemical testing, and regular health evaluations. The main outcomes measured are the recommended dosage for Phase II and the cancer's response to treatment over six months. Participants will be monitored for safety and treatment effects throughout the study period, which includes initial treatment and follow-up assessments.

Researchers are evaluating the safety, tolerability, how the body processes the drug, and early antitumor effects of BG-C137, an antibody-drug conjugate targeting FGFR2b, alone and combined with other anticancer drugs in people with advanced solid tumors. This study includes two phases: Phase 1a focuses on dose escalation and safety, while Phase 1b involves dose expansion. The trial is sponsored by BeOne Medicines, formerly BeiGene. Participants receive BG-C137 through intravenous infusion. In combination groups, anticancer agents are given either intravenously or orally. Phase 1a includes monotherapy dose escalation, safety expansion, and combination dose confirmation and safety expansion. Phase 1b focuses on dose expansion. The study will determine the maximum tolerated dose, recommended doses for expansion, and overall response rates over approximately two years. During the study, participants will undergo evaluations including safety monitoring for adverse events, pharmacokinetic and pharmacodynamic assessments, and tumor response measurements using RECIST v1.1 criteria. Researchers will collect tumor tissue samples to assess FGFR2b expression and other biomarkers. Participants' physical function, organ health, and prior treatments will be reviewed. The total study duration may last up to about two years, with close monitoring of side effects and treatment effects throughout.