Tang Shan Shi

Researchers are evaluating TQB2934, a special antibody designed to treat multiple myeloma, a type of malignant plasma cell tumor. TQB2934 is a double-specific antibody that binds to both the CD3 receptor on T cells and the BCMA antigen on cancerous plasma cells. This binding helps recruit and activate T cells to attack and kill the cancer cells. The study is a Phase 1 clinical trial focusing on the safety and pharmacokinetics of this treatment in adults with multiple myeloma. The treatment involves subcutaneous injections of TQB2934. The antibody works by activating T cells to release substances that kill BCMA-positive target cells. The study monitors participants over time to assess how the drug is processed in the body, including measures like peak drug concentration and elimination half-life within 120 hours after administration. The trial also tracks adverse events for up to 24 months. Participants will undergo various laboratory tests and assessments to meet study requirements and monitor their health throughout the trial. Researchers will evaluate pharmacokinetics, including peak time, drug concentration, and clearance, as well as safety by recording any adverse events. The study includes careful monitoring of participants' condition and treatment responses, with follow-up lasting up to two years to ensure comprehensive safety data collection.

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 combining TQ05105 Tablets and TQB3617 Capsules in patients with intermediate- and high-risk Myelofibrosis. This open, single-arm, multi-center clinical trial is conducted in Phase Ib/II to study this combination treatment in adults with this condition. The goal is to find the best dose and assess how well the treatment works, including measuring spleen size reduction. The study treatment includes TQ05105 Tablets, which inhibit Janus kinase 1 and 2, and TQB3617 Capsules, which inhibit Bromodomain and Extra-Terminal proteins. Participants receive these drugs together, but specific dosing schedules are not detailed in the provided information. The study includes multiple phases to evaluate safety and dose levels for up to two years. Participants will undergo various assessments, including measuring spleen volume changes and determining maximal tolerated doses. The main outcomes include the recommended phase II dose and spleen volume reduction over 24 weeks and up to two years. Safety monitoring and evaluation of symptom scores are also part of the follow-up during the study period, helping researchers understand the treatment impact and tolerability.

Researchers are evaluating TQB2102, a new antibody-drug conjugate designed to target tumor cells in patients with recurrent or metastatic advanced gynecological tumors. This Phase 2 study focuses on assessing the safety and effectiveness of TQB2102, which combines a humanized antibody against HER2 with a powerful drug payload to kill cancer cells more specifically and potently than traditional treatments. The study includes patients who have not responded successfully to previous platinum-based chemotherapy. Participants will receive TQB2102 injections, which is a HER2 dual-antibody-drug conjugate. The treatment is given to women with measurable lesions confirmed by RECIST 1.1 criteria, and who have varying levels of HER2 expression in their tumor tissue. Women of childbearing potential must have a negative pregnancy test before starting and agree to use highly effective contraception throughout the study. The treatment period and dosing schedules are designed to monitor the drug's impact carefully. Throughout the study, participants will be closely monitored for overall response rate up to 12 months. Assessments include regular evaluations of tumor response, safety checks, and compliance with treatment. The study excludes patients with certain health conditions, recent surgeries, or other treatments that might interfere. The total duration and detailed follow-up procedures ensure thorough observation of TQB2102's effects and participant safety.

Researchers are evaluating CID-103, a new anti-CD38 monoclonal antibody, in adults with chronic immune thrombocytopenia (ITP) to determine its safety and effectiveness. This global Phase 1/2 study aims to find safe dosing levels and the best dose for future studies, focusing on adults aged 18 to 65 who have persistent ITP. The trial seeks to offer a new treatment option for people who have not responded well to current therapies. The study has two parts: Part A tests increasing doses of CID-103 to assess safety and tolerance and to identify a safe dose range. Part B compares up to three different doses to evaluate how well the drug works and gathers more safety information to select the optimal dose. Participants receive CID-103 through intravenous (IV) infusion once weekly for 6 weeks, then every two weeks up to Week 12. If treatment continues beyond Week 12, dosing occurs monthly for up to six months total treatment. During the study, participants will be closely monitored for safety and platelet response. Assessments include blood tests to measure platelet counts and regular safety evaluations over 10 months. The study includes a post-treatment safety follow-up period to check ongoing effects. Overall, participants are involved in treatment and monitoring visits for up to six months with additional follow-up to ensure safety and evaluate outcomes.

Researchers are evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and immune response to multiple doses of STSA-1301 given by subcutaneous injection in healthy adults and patients with Primary Immune Thrombocytopenia (ITP). The study also aims to explore the initial effectiveness of STSA-1301 in treating patients with ITP. This is a Phase Ib/II randomized, double-blind, placebo-controlled trial designed to gather detailed information on the drug's effects and safety profile. Participants will receive multiple doses of either STSA-1301 subcutaneous injections or a placebo according to a schedule specified in the study protocol. The trial includes two stages: one involving healthy subjects aged 18 to 50 years and another involving patients aged 18 to 75 years diagnosed with persistent or chronic primary ITP. The study allows patients to continue stable doses of certain ITP medications during participation. During the 78-day study period, participants will be closely monitored for any adverse events following drug administration. Researchers will collect data on safety, drug behavior in the body, immune responses, and initial treatment responses. Participants will undergo medical history reviews, physical exams, lab tests, and other assessments to ensure safety and gather study data. The total study duration includes screening, treatment, and follow-up to assess both immediate and longer-term effects of the drug.

Researchers are evaluating the effectiveness, safety, and how the body processes HMPL-760 combined with R-GemOx compared to a placebo plus R-GemOx in patients with relapsed or refractory Diffuse Large B-Cell Lymphoma (DLBCL). This Phase III randomized, double-blind study aims to provide clearer evidence for treatment options in this patient group. The study includes multiple phases such as screening, treatment, safety observation, progression-free survival follow-up, and overall survival follow-up. Participants will be randomly assigned to receive either HMPL-760 or a placebo, both taken orally once daily. All patients will also receive the R-GemOx chemotherapy regimen in 21-day cycles for a total of 8 cycles. This includes rituximab given intravenously on the first day of each cycle, followed by gemcitabine and oxaliplatin administered intravenously on the second day. The study treatment period lasts up to approximately two years, covering treatment and follow-up phases. During the study, participants will undergo regular assessments to monitor their health and treatment response, including measuring progression-free survival, overall survival, and any systemic antitumor therapy usage. Researchers will also track any premature withdrawal from the study treatment and observe safety outcomes over the course of up to two years. The study involves detailed evaluation through scans, laboratory tests, and clinical evaluations to ensure comprehensive monitoring of patient status.

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.

This trial studies patients with limited stage small cell lung cancer who have not shown disease progression after concurrent chemoradiation therapy. It is a randomized, double-blind, phase III clinical study designed to compare the effectiveness and safety of the drug AK112 against a placebo as a consolidation treatment. The goal is to evaluate the potential benefits of AK112 in improving outcomes for these patients. Participants receive either AK112 at a dose of 20 mg/kg or a placebo, both administered intravenously every three weeks (Q3W). The treatment is given as consolidation therapy following initial chemoradiation, aiming to maintain disease control. The study involves two groups: one receiving AK112 and the other receiving placebo, with both treatments delivered under double-blind conditions. Throughout the trial, researchers monitor participants for up to approximately six years, focusing on progression-free survival and overall survival as primary outcomes. Patients undergo regular assessments to track disease status and safety, including blinded independent center reviews. The long-term follow-up ensures comprehensive evaluation of treatment effects and participant safety over time.

Researchers are evaluating the safety and effectiveness of TQB2102 for injection, a HER2 dual-antibody-drug conjugate, in treating patients with HER2-positive biliary tract cancer. This study focuses on patients aged 18 to 75 years who have advanced or metastatic biliary tract cancer confirmed by specific tests and who have failed 1-2 prior systemic therapies. The trial is conducted in Phase 1 and Phase 2 stages to determine the recommended dose and assess adverse events. Participants receive TQB2102 injections as part of the treatment. This study includes a screening period to confirm eligibility, followed by treatment cycles where participants are monitored closely. Women of reproductive age and men must agree to use effective contraception during and for six months after the study. The study also excludes patients with certain medical conditions, recent treatments, or prior anti-HER2 therapies depending on the stage. During the study, participants undergo tumor evaluations, safety assessments, and laboratory tests to monitor the drug's effects and side effects. Researchers collect data on adverse events from the time participants consent until 28 days after the last dose or start of new antitumor therapy. The study period includes up to 24 weeks to establish the recommended dose and long-term monitoring to ensure participant safety and treatment adherence.