Shi Jia Zhuang Shi

Researchers are evaluating the safety and effectiveness of a drug called B001 injection in patients who have neuromyelitis optica spectrum disorder (NMOSD) and test positive for aquaporin-4 antibodies. This study is a multicenter, randomized, double-blind, placebo-controlled Phase II/III clinical trial designed to compare B001 with a placebo in this patient population. The goal is to assess whether B001 can reduce the time to the first NMOSD attack during the study period. Participants will receive either an intravenous dose of B001 or a matching placebo on Day 1 and Day 15 during the randomized controlled period (RCP). Both treatment groups follow the same dosing schedule to evaluate the effects of B001 compared to placebo over approximately 48 weeks. During the study, participants will be closely monitored through regular assessments to track any NMOSD attacks and overall health. Researchers will measure the time to the first NMOSD attack as the primary outcome. Safety and any side effects of the treatment will also be evaluated throughout the study period. Participants are expected to complete all required tests and follow study procedures as part of their involvement.

Researchers are investigating treatments for patients with locally advanced or metastatic gastric adenocarcinoma or adenocarcinoma of the gastroesophageal junction who have experienced failure after first-line treatment. This phase III, multicenter, randomized, controlled clinical trial compares the effects of two chemotherapy drugs, Docetaxel for injection (Albumin-bound) and Taxotere, in this patient population. The study aims to evaluate and compare the efficacy and safety of these treatments following prior systemic therapy failure. About 630 participants will be randomly assigned to either the test group receiving Docetaxel for injection (Albumin-bound) or the control group receiving Taxotere. Both treatments are administered by intravenous infusion every three weeks and will continue until the disease progresses. Regular visits and imaging examinations are conducted throughout the treatment period to monitor the response and safety. During the study, participants undergo routine assessments including imaging scans to measure tumor response based on RECIST V1.1 criteria. Safety and treatment effects are monitored continuously, and the primary outcome measured is overall survival at the end of the first treatment cycle (21 days). The study includes follow-ups and safety monitoring to assess long-term outcomes and patient well-being throughout the trial duration.

Researchers are investigating a treatment for precursor B-cell Acute Lymphoblastic Leukemia (B-ALL) in patients whose cancer has either returned after treatment or stopped responding to current therapies. This study has two parts: an initial dose escalation phase to evaluate the safety and find the best tolerated dose of the drug MK-1045, followed by a Phase II part to assess how well MK-1045 works in treating B-ALL. MK-1045 is given through an intravenous infusion once a week in cycles of 4 weeks, starting with two induction cycles. After a 2-week break, patients who respond to induction receive three consolidation cycles, followed by up to seven maintenance cycles or until certain conditions occur, such as intolerable side effects, disease progression, or withdrawal from the study. Each 4-week treatment cycle is followed by a 2-week treatment-free interval. Participants will be closely monitored throughout the study, including during the dose escalation phase lasting up to about 24 months and the Phase II part lasting up to about 10 weeks. Researchers will track side effects, treatment discontinuations due to adverse events, dose-limiting toxicities, and the maximum tolerated dose of MK-1045. They will also measure the rate of complete remission to understand the drug's effectiveness in this patient population.

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.

This study is a multicenter, open-label, phase I/II study of YL205 in China to evaluate the safety, tolerability, PK characteristics and preliminary efficacy of YL205 in the following selected patients with advanced solid tumors.

Researchers are evaluating HLX10 monotherapy in a phase II clinical trial for patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors. These patients have experienced disease progression or intolerable side effects after standard cancer treatments. The study aims to assess the clinical effectiveness and safety of HLX10, a recombinant humanized anti-PD-1 monoclonal antibody, in this patient group. Participants will receive HLX10 as an intravenous infusion at a dose of 3 mg/kg every two weeks. Treatment will continue until the patient no longer benefits, experiences intolerable toxicity, withdraws consent, or completes up to 2 years of treatment (52 dosing periods). The study includes three periods: a 28-day screening phase, the treatment phase, and a follow-up phase that involves safety and survival monitoring. During the study, participants will undergo assessments including tumor measurements and laboratory tests to track treatment response and safety. Researchers will evaluate the overall response rate for up to 2 years. Regular monitoring will include imaging, blood tests, and collection of tumor tissue samples. Safety follow-up and survival status will be tracked after treatment ends to understand long-term outcomes and tolerability.

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 efficacy and safety of TQ05105 tablets in patients with moderate to severe chronic graft-versus-host disease (cGVHD) who have already received systemic therapies. This is an open-label, multicenter Phase II clinical trial focusing on patients aged 18 to 70 years old who have undergone allogeneic hematopoietic stem cell transplantation and have stable disease requiring further treatment. The study aims to measure the objective response rate at 24 weeks to assess treatment impact. TQ05105 tablets contain Rovadicitinib, a novel oral drug that inhibits JAK 1/2 and ROCK 1/2 enzymes, targeting both inflammatory and fibrotic components of cGVHD. Participants will receive this drug as part of the trial, and their response to treatment will be carefully monitored during the study period. The trial involves patients who have previously been treated with immunosuppressants and are on a stable dose of glucocorticoids or other therapies. Participants will undergo regular assessments including blood tests to measure neutrophil, platelet, and hemoglobin levels, as well as liver, kidney, and coagulation function tests. Researchers will monitor safety and treatment response throughout the 24-week study period. Patients must agree to use contraceptive measures during and for six months after the trial. The study excludes those with recent malignancies, active acute GVHD, recent infections, recent use of similar inhibitors, or other serious uncontrolled illnesses.

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 the safety, tolerability, and pharmacokinetics of TQB3455 tablets in adults with hematological cancers, specifically acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). TQB3455 is an inhibitor targeting the IDH2 mutant enzyme. The study is divided into two phases: the first phase assesses safety and tolerability of single or multiple doses in patients with malignant blood tumors, while the second phase studies the efficacy and safety of TQB3455 alone or in combination with azacitidine for injection in AML or MDS patients. The treatment involves oral administration of TQB3455 tablets, either alone or combined with azacitidine, a drug used for demethylation therapy. The study aims to determine the maximum tolerated dose and observe dose-limiting toxicities. Participants receive the investigational treatment according to assigned groups, with ongoing safety monitoring during the study period lasting up to 48 weeks. Participants will undergo assessments including monitoring for dose-limiting toxicities, overall remission rates, and pharmacokinetic evaluations throughout the study. Safety and efficacy data will be collected up to 48 weeks, with follow-up visits to assess treatment response and adverse events. The total duration includes baseline screening, treatment phases, and extended monitoring to evaluate the drug's impact and tolerability in hematological malignancy patients.