Ha Er Bin 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 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.

Researchers are evaluating the safety and effectiveness of the SHR-A1811 drug combination in patients with HER2-positive locally advanced or metastatic biliary tract cancer. This open, multicenter Phase II clinical trial focuses on patients aged 18 to 75 years old with measurable disease and good overall health status. The study aims to better understand how this treatment affects this specific type of cancer. The treatment involves the use of three drugs: SHR-A1811, SHR-1316, and SHR-8068. Participants will receive this combination as part of the study, with the goal of assessing its impact on tumor response. The trial includes patients who have not received prior systemic anticancer therapy or who had previous radical therapy completed at least six months before disease recurrence. Participants will be closely monitored from screening through study completion, which is expected to last about three years on average. Researchers will regularly assess tumor response according to standard guidelines, track safety and side effects, and evaluate overall treatment effects. Key outcomes include the objective response rate as judged by investigators throughout the study period.

Researchers are evaluating the safety and effectiveness of SPH5030 tablets in patients with Her2-positive or mutated biliary tract or colorectal cancer. This Phase II clinical trial focuses on people with metastatic or advanced forms of these cancers who meet specific health criteria and have not previously received certain targeted therapies. Participants will receive SPH5030 tablets orally once daily at a dose of 600 mg. The study is designed as a single-arm, open-label trial conducted at multiple centers. Treatment continues as per protocol, with patients monitored for response and safety throughout the study period. During the trial, participants will be regularly assessed for their response to treatment, including the objective response rate over approximately two years. Researchers will monitor safety, side effects, and overall health through clinical evaluations and laboratory tests. The study includes ongoing observation to evaluate the drug's impact and patient well-being during and after treatment.

Researchers are investigating the safety, tolerability, pharmacokinetics, and early effectiveness of SYS6023, a new antibody-drug conjugate targeting HER3, in people with advanced solid tumors. This open-label, Phase I study is conducted at multiple centers and aims to find appropriate dose levels and evaluate treatment effects in various tumor types, including breast cancer, non-small cell lung cancer, ovarian cancer, and others with specific molecular profiles. Participants will receive SYS6023 as an intravenous infusion on the first day of each 21-day treatment cycle. Treatment continues until the disease worsens, unacceptable side effects occur, another anti-tumor treatment begins, consent is withdrawn, follow-up is lost, or death. The study includes a dose-escalation phase followed by cohort expansion to evaluate different groups based on tumor type and molecular markers. During the study, participants will undergo assessments for side effects, including dose-limiting toxicities, and adverse events for up to two years. Researchers will also monitor pharmacokinetics and determine the recommended Phase 2 dose. Tumor responses will be evaluated using standard criteria, and safety will be closely followed through laboratory tests, imaging, and clinical evaluations. Participation duration depends on individual treatment response and safety outcomes.

Researchers are investigating treatments for women with recurrent endometrial cancer that expresses different levels of the HER2 protein. The study has two groups based on the tumor's HER2 score: Cohort 1 includes patients with HER2 IHC 1+ or 2+ who have previously received immune checkpoint inhibitors and platinum-based chemotherapy, while Cohort 2 includes patients with HER2 IHC 3+. The purpose is to compare the effectiveness and safety of the investigational drug BNT323 (also called DB-1303) against chemotherapy in Cohort 1 and to evaluate BNT323 alone in Cohort 2. The study also looks at how the drug affects the immune system, the body's handling of the drug, quality of life, and potential side effects. Participants in Cohort 1 are randomly assigned to receive either BNT323 via intravenous infusion or a chemotherapy drug chosen by the investigator (doxorubicin, paclitaxel, or docetaxel if paclitaxel is unsuitable). Treatment continues until the cancer progresses, unacceptable side effects occur, or the participant withdraws consent. Those in Cohort 2 receive BNT323 alone until disease progression or other discontinuation criteria are met. The study includes a screening period, a treatment period expected to last about six months, followed by safety monitoring, efficacy follow-up, and long-term survival follow-up lasting up to approximately 53 months. During the study, participants undergo regular assessments including imaging scans to measure tumor response by RECIST criteria, safety monitoring for adverse effects, and evaluations of quality of life. Researchers also study the pharmacokinetics of BNT323 and the immune response. The main outcomes measured are progression-free survival in Cohort 1 and objective response rate in Cohort 2. Safety follow-up ensures ongoing monitoring after treatment to evaluate longer-term effects and participant wellbeing.

Researchers are evaluating the effectiveness and safety of TQB2102 injection compared to a combination of docetaxel, trastuzumab, and pertuzumab in treating adults with HER2 positive recurrent or metastatic breast cancer. This Phase III, randomized, open-label, multicenter trial aims to compare these treatments in patients who have not received systemic anti-tumor therapy during their recurrence or metastasis stage, except for limited first-line endocrine therapy. Participants must have HER2 positive invasive breast cancer confirmed by pathology and measurable lesions. Participants are randomly assigned to one of two treatment groups in equal numbers. One group receives TQB2102, a next-generation HER2 Antibody-Drug Conjugate, while the other group receives docetaxel combined with trastuzumab and pertuzumab as a positive control. The study monitors the patients during treatment and collects data on tumor response and progression. During the study, participants undergo regular assessments including imaging to measure tumor size and progression according to RECIST 1.1 criteria. Researchers track the objective response rate and progression-free survival for up to approximately 30 months. Safety and adverse events are monitored throughout the trial, and participants must have good compliance and major organ function to continue. The study includes long-term follow-up to assess treatment outcomes and tolerability.

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.