Tang Shan Shi

Researchers are evaluating TQB2934, a special antibody designed to target multiple myeloma, a cancer affecting plasma cells. This antibody binds to T cells and cancer cells to activate the immune system to attack the disease. The study is a Phase 1 clinical trial focusing on safety and the bodys handling of the drug in patients with malignant plasma cell tumors. The study involves giving TQB2934 as a subcutaneous injection at doses of 40mg or 60mg. Treatment cycles occur once weekly during the first three cycles, then every two weeks for cycles four to six. If patients achieve a partial remission or better after six cycles, dosing continues every four weeks. Each treatment cycle lasts 28 days. Participants will undergo various assessments including blood tests to measure drug levels and immune response over 120 hours after each dose. Researchers will monitor adverse events for up to 24 months and evaluate treatment responses such as remission rates and survival outcomes. The total study participation includes treatment and long-term safety follow-up lasting up to two years.

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 safety and effectiveness of TQ05105 Tablets combined with TQB3617 Capsules in people with intermediate- and high-risk Myelofibrosis, a type of bone marrow cancer. This open, single-arm, multi-center clinical trial is sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. and aims to find the best dose and measure improvements in spleen size and symptoms over time. Participants will take TQ05105 Tablets, which target Janus kinase 1 and 2 enzymes, together with TQB3617 Capsules, which inhibit bromodomain and extra-terminal proteins. Both medications are taken orally in 21-day treatment cycles. The study includes an initial phase to determine the maximum tolerated dose and recommended dose, followed by longer evaluation periods lasting up to 120 weeks. During the study, participants will undergo regular assessments including measurement of spleen volume, symptom questionnaires, gene mutation analysis, and monitoring of side effects. The main outcomes focus on spleen volume reduction and symptom improvement, as well as survival and safety over the study period. Total participation may last up to two years, with ongoing monitoring to evaluate treatment response and tolerability.

Researchers are evaluating TQB2102, an antibody-drug conjugate designed to target Human Epidermal Growth Factor Receptor 2 HER2 positive tumor cells, in patients with recurrent or metastatic advanced gynecological tumors. This Phase 2 study aims to assess the safety and effectiveness of TQB2102 in this patient population, addressing the need for new treatments after unsuccessful platinum-based chemotherapy. Participants will receive TQB2102 through intravenous infusion every three weeks, with each treatment cycle lasting 21 days. This investigational drug combines a humanized antibody with a potent drug payload to specifically attack tumor cells. The study includes monitoring for adverse events and anti-drug antibodies during treatment and follow-up. During the trial, participants will undergo regular assessments including tumor measurements to evaluate overall response rate, duration of remission, progression-free survival, overall survival, and disease control rate for up to 12 to 17 months. Safety evaluations will continue until 28 days after the last dose or the start of new cancer therapies. Blood samples for anti-drug antibody testing will be collected at specific treatment cycles and after treatment completion. The total involvement period depends on individual treatment duration and follow-up schedules.

Researchers are evaluating CID-103, a new anti-CD38 monoclonal antibody, in adults with chronic immune thrombocytopenia ITP to assess its safety and effectiveness. This global Phase 12 trial aims to find a safe dose range and the optimal dose for further studies, particularly for patients who have not responded well to current treatments. The study is sponsored by CASI Pharmaceuticals, Inc. and involves adults aged 18 to 65 with chronic ITP diagnosed according to established guidelines. The study has two parts Part A uses an accelerated dose escalation design to test increasing doses of CID-103 delivered by intravenous infusion. If significant side effects occur, the study switches to a standard dose escalation design. Part B is a randomized, open-label phase comparing up to three selected doses low, intermediate, and high to evaluate safety, tolerability, and platelet response. Treatment is given weekly for 6 weeks, then every two weeks up to week 12, and monthly if extended, for up to six months total. Participants will undergo regular monitoring during the treatment and a post-treatment safety follow-up period. Researchers will assess safety, tolerability, platelet counts, and platelet response over 12 weeks and up to 10 months. Other evaluations include organ function and response to prior treatments. The study includes detailed safety reviews and dose adjustments based on participant reactions, aiming to identify a dose regimen suitable for future clinical trials.

Researchers are studying the safety, tolerability, and pharmacological effects of multiple doses of STSA-1301 subcutaneous injection in both healthy individuals and patients with Primary Immune Thrombocytopenia ITP. This randomized, double-blind, placebo-controlled trial also explores the initial effectiveness of STSA-1301 in patients with ITP. The study is sponsored by Jiangsu BioJeTay Biotechnology Co., Ltd. and aims to better understand how this treatment influences platelet counts and immune markers. Participants receive different doses of STSA-1301 or a placebo as subcutaneous injections according to the study protocol. The trial includes multiple dose levels low, median, and high doses, administered in separate cohorts. The study design is parallel and randomized, ensuring participants are assigned to one of the treatment groups or placebo without knowing their group. Treatments are given on specified dates, with monitoring for safety and immune responses over the course of the study. During the trial, participants undergo regular assessments including blood tests to measure platelet counts, immune markers such as serum IgG, cytokines, and anti-drug antibodies, as well as pharmacokinetic parameters like drug concentration in the blood. Researchers monitor any adverse events and changes in bleeding scores over a 78-day period following treatment. The study includes healthy volunteers and patients aged 18 to 75 years and lasts until September 2026. Participants will be closely observed throughout for treatment effects and safety.

Researchers are evaluating the efficacy, safety, pharmacokinetics, and pharmacodynamics of SR604 in adults with von Willebrand disease VWD. This Phase II trial focuses on understanding how SR604 works and its effects in treating patients diagnosed with VWD who have experienced recent bleeding episodes. Participants will receive SR604 through subcutaneous injections given as multiple doses every 4 weeks or at varying intervals of 4, 6, or 8 weeks, depending on the dose group they are assigned to. The study consists of four cohorts exploring different dosing schedules to assess treatment effects over approximately one year. Throughout the trial, participants will be closely monitored for bleeding rates, drug levels in the blood, and safety outcomes such as adverse events and antibody responses. Health status questionnaires and blood tests will be conducted regularly to evaluate treatment impact and pharmacokinetic parameters. The total participation duration is about 52 weeks, during which researchers will collect detailed data on bleeding frequency and treatment safety.

Researchers are evaluating the combination of HMPL-760 with the R-GemOx regimen compared to placebo with R-GemOx in adults with relapsed or refractory diffuse large B-cell lymphoma DLBCL. This Phase III randomized, double-blind, positive-controlled study aims to assess the efficacy, safety, and pharmacokinetics of HMPL-760 in this patient population. The trial includes multiple phases such as screening, treatment, safety observation, progression-free survival follow-up, and overall survival follow-up. Participants are assigned to one of two groups one group receives HMPL-760 orally once daily in combination with the R-GemOx chemotherapy regimen, and the other group receives a placebo orally once daily with the same R-GemOx regimen. The R-GemOx treatment consists of rituximab given intravenously on Day 1, followed by gemcitabine and oxaliplatin intravenously on Day 2, repeated every 21 days for a total of 8 cycles. The study includes a safety observation period after treatment and long-term follow-up periods to monitor progression-free and overall survival. During the study, participants undergo various assessments including physical exams, safety monitoring, and evaluations of treatment response. Researchers measure progression-free survival, overall survival, response rates, duration of response, clinical benefit, and pharmacokinetics of HMPL-760. These assessments occur up to approximately two years. Participants adherence and safety are closely monitored throughout the trial, which lasts until the study completion date in late 2028.

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.

Researchers are evaluating AK112, a PD-1VEGF bispecific antibody, as a consolidation treatment for patients with limited stage small cell lung cancer who have not shown disease progression after concurrent chemoradiation therapy. This phase III, randomized, double-blind study aims to compare the effectiveness and safety of AK112 against a placebo in this specific patient group. Participants will receive either AK112 or a placebo intravenously every three weeks as consolidation therapy following their initial chemoradiation. The study includes two groups one receiving AK112 at a dose of 20 mgkg every three weeks, and the other receiving a matching placebo on the same schedule. Treatment continues under close monitoring to assess outcomes. Throughout the study, participants will undergo regular assessments including scans and evaluations to monitor progression-free survival and overall survival over approximately six years. Additional outcome measures include response rates and disease control rates assessed by both independent review and investigators, along with safety monitoring for adverse events. This long-term follow-up helps researchers understand how the treatments perform and their impact on patient health.