Cheng De 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 TQB3107, a targeted inhibitor designed to induce cell death and stop tumor growth, in patients with advanced cancers. This Phase I clinical trial aims to assess the safety and tolerability of TQB3107 tablets, determine dose-limiting toxicities, find the maximum tolerated dose, and recommend a dose for future Phase II studies. Participants receive TQB3107 tablets following one of two dosing schedules either daily for five consecutive days each week with a two-day break per 28-day cycle, or intermittent dosing every 28 days. The study begins with an initial single fasting dose followed by a seven-day observation before continuing the dosing cycles. This design allows researchers to monitor participants closely during the first cycle to assess safety and dosing effects. During the study, participants will have regular assessments including pharmacokinetic blood sampling at multiple time points to measure drug levels, and evaluations of dose-limiting toxicities and maximum tolerated dose at the end of the first 28-day cycle. Longer-term outcomes such as response rates, disease control, progression-free survival, and overall survival will be followed for up to three years. Participants are monitored for up to 24 months for recommended dosing and safety, with comprehensive evaluations throughout the study period.

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 the safety, tolerability, and effectiveness of TQB3909 tablets combined with azacitidine in adults with myeloid malignancies, including acute myeloid leukemia and myelodysplastic syndromes. This open, multi-center clinical trial is designed as a Phase IbII study to better understand how this combination treatment works in these blood cancers. Participants receive TQB3909 tablets once daily in 28-day treatment cycles along with azacitidine. The study focuses on monitoring how well patients tolerate the treatment and its effects on their disease. The trial includes assessment of various response rates and survival outcomes over several weeks. Throughout the trial, participants undergo regular evaluations including monitoring for adverse events and laboratory tests for up to 24 weeks. Researchers measure remission rates, duration of remission, and survival outcomes up to 60 weeks. Participants safety and response to treatment are closely tracked during the study.

This trial investigates TQ05105 tablets in adults with intermediate or high-risk myelofibrosis, a type of bone marrow cancer. It includes two groups one studying how the drug behaves in the body in participants with different levels of kidney function, and another assessing the drugs safety and effect in those who have not responded well or cannot tolerate previous Janus kinase JAK inhibitor treatments. The study is a phase II, open-label, single-arm, multicenter trial. Participants receive TQ05105 tablets in 28-day treatment cycles. The first group focuses on pharmacokinetics to guide dosing for normal to moderate kidney impairment. The second group evaluates the drugs safety and potential benefits in participants with spleen enlargement and prior JAK inhibitor therapy that was ineffective or intolerable. Treatment continues with regular dosing and monitoring. During the study, participants undergo assessments including measurements of spleen volume reduction and various pharmacokinetic parameters such as drug concentration over time. Safety is monitored through recording adverse events during treatment and up to 4 weeks after the last dose. Additional outcomes include symptom assessments, survival rates, and blood transfusion needs. The study lasts up to several years, with primary measurements at 24 weeks and extended follow-up averaging three years.

Researchers are evaluating the effectiveness and safety of TQB3473 tablets compared to a placebo in adults with primary immune thrombocytopenia ITP who have not responded well to standard corticosteroid and other ITP treatments. This randomized, double-blind, placebo-controlled Phase III clinical trial aims to show that TQB3473 can improve the sustained platelet response rate in these patients. The study is sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Participants will be randomly assigned to receive either TQB3473 tablets at a dose of 600 mg once daily or a placebo once daily, both for 24 consecutive weeks. The study includes a treatment period followed by a safety follow-up period. The trial carefully monitors platelet counts and bleeding events throughout the treatment duration. During the study, participants will have regular assessments including platelet count measurements, evaluations of bleeding events, and monitoring for any adverse effects. Researchers will track the durable response rate between weeks 14 and 24, as well as response rates and effectiveness within the first 12 weeks. Safety is closely monitored from consent signing until 28 days after the last dose or the start of new ITP treatment. The total participation covers the treatment and safety follow-up periods.

Researchers are evaluating whether combining tucatinib with trastuzumab and mFOLFOX6 works better than standard treatments for people with HER2 positive colorectal cancer that has spread or cannot be removed by surgery. This Phase 3 study also aims to learn about the side effects that may occur when taking this combination of drugs. Participants have metastatic or unresectable colorectal cancer and are randomly assigned to different treatment groups. Participants are randomly placed in one of two study groups. One group receives tucatinib taken orally twice daily along with trastuzumab given intravenously every 3 weeks and mFOLFOX6 chemotherapy every 2 weeks. The other group receives standard care, which may be mFOLFOX6 alone or combined with bevacizumab or cetuximab, both given intravenously on different schedules. Tissue samples and biopsies are collected before treatment to confirm HER2 positivity and other markers. During the study, participants will have regular evaluations including imaging scans to measure cancer progression, blood tests, and assessments of side effects and quality of life. Progression-free survival is the primary outcome measured for up to about 3 years, with other outcomes like overall survival and response rate also tracked. Safety monitoring continues for about one year after the last treatment. The study lasts several years, with ongoing follow-up to understand long-term effects and benefits.

Researchers are evaluating the effects and safety of efgartigimod given intravenously in adults with primary immune thrombocytopenia ITP, a condition where the immune system attacks platelets. This phase 3 clinical trial aims to determine how well efgartigimod controls platelet counts compared to a placebo during a 24-week double-blinded treatment period. The study is sponsored by argenx and includes follow-up periods to monitor ongoing effects and safety. Participants will be randomly assigned in a 21 ratio to receive either efgartigimod IV or placebo IV during the double-blinded treatment period. After this, all participants will receive efgartigimod IV during a first 52-week open-label treatment phase, followed by an optional second 52-week open-label phase. After completing these treatment periods, participants will have an approximately 8-week follow-up while off the study drug, with total study participation lasting up to 138 weeks. During the study, participants will have regular blood tests to measure platelet counts and assess disease control. Researchers will track the number of weeks participants maintain platelet counts above specified levels and monitor any bleeding events or adverse effects. Safety is closely observed throughout the trial, including antibody responses to the drug. Participants will have scheduled visits and assessments throughout treatment and follow-up to gather comprehensive data on efgartigimods impact.

Researchers are evaluating the drug HMPL-306 compared to salvage chemotherapy in patients with relapsed or refractory acute myeloid leukemia AML who have mutations in the IDH1 or IDH2 genes. This phase III, multicenter, open-label study divides patients into two groups based on their specific IDH mutation and investigates the effectiveness, safety, and pharmacokinetics of HMPL-306. The trial aims to provide new treatment options for AML patients with these genetic mutations who have not responded to prior therapies. Patients are randomly assigned to receive either HMPL-306 monotherapy or one of several salvage chemotherapy regimens selected by their investigator. HMPL-306 is given orally at 250 mg once daily for the first 28-day cycle, then 150 mg once daily for subsequent cycles. Salvage chemotherapy options include intensive regimens like EAMitox and FLAGIda, or less intensive treatments like azacitidine and LoDAC. Treatment continues in 28-day cycles until treatment failure or other study-defined endpoints. Participants will undergo genetic testing to confirm IDH mutation status before enrollment and will be closely monitored throughout the study. This includes bone marrow biopsies, quality of life assessments, and evaluations of treatment response and safety using established criteria. Follow-up extends beyond treatment discontinuation, including safety monitoring and long-term tracking of survival and disease progression. The total study duration may last up to approximately 33 months depending on individual patient outcomes and study progress.

Researchers are conducting a multi-center, randomized, open-label clinical study to evaluate and improve the accuracy of the target-controlled infusion TCI model for cipepofol during general anesthesia in patients undergoing elective surgery. The study aims to verify and optimize the infusion parameters to ensure precise control of drug delivery in this setting. Participants will be randomly assigned to one of two groups receiving different plasma target-controlled concentrations of cipepofol during anesthesia induction a low concentration group 0.9 bcgml and a high concentration group 1.2 bcgml. An interim analysis will be done after collecting about 5% of data from each group to evaluate key parameters like the effect-site equilibrium rate constant Ke0. During the study, participants will undergo general anesthesia with tracheal intubation for elective surgeries lasting at least one hour. Researchers will monitor vital signs, anesthesia effects, and infusion accuracy, focusing on optimizing parameters such as CeLoCCeRoC and Ke0 within two hours. The study will include screening for eligibility, informed consent, and close observation throughout surgery with ongoing assessments to ensure safety and data quality.