Ning Bo Shi

Researchers are evaluating a new treatment called ifinatamab deruxtecan (I-DXd) for men with metastatic castration-resistant prostate cancer (mCRPC). This study compares I-DXd to chemotherapy to see if it helps people live longer overall and live longer without their cancer worsening. It is a Phase 3, open-label trial focused on patients who have progressed on prior therapies and have evidence of metastatic disease. Participants receive either I-DXd through an intravenous infusion every 3 weeks or docetaxel chemotherapy administered every 3 weeks. Prednisone tablets are also given daily as part of the treatment plan. Before each I-DXd dose, premedication is provided to help prevent nausea and vomiting using a combination of drugs such as corticosteroids and anti-nausea medicines. Treatment continues until disease progression, unacceptable side effects, or other reasons to stop. During the study, researchers monitor overall survival and how long patients live without their cancer progressing, for up to about 36 months. Participants undergo tumor tissue collection, scans, and assessments to track disease status and side effects. Safety is closely watched throughout treatment. The study includes men aged 18 and older with confirmed prostate cancer and metastatic disease who have previously received certain hormone therapies but no prior taxane chemotherapy for mCRPC.

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 effectiveness, safety, and tolerability of subcutaneous ianalumab in adults with diffuse cutaneous systemic sclerosis. This Phase 2 study compares ianalumab with a placebo in participants diagnosed according to established classification criteria, focusing on those with active disease and specific autoantibodies. The goal is to better understand ianalumab's impact on this condition over a long treatment period. The study includes several phases: up to 6 weeks for screening, followed by a 52-week initial treatment period where participants receive either ianalumab or placebo by subcutaneous injection. After this, there is a second 52-week open-label treatment period where all participants receive ianalumab. Finally, a post-treatment follow-up period lasts at least 20 weeks and can extend up to 2 years after the last dose. Participants will undergo various assessments throughout the study, including evaluations of their skin condition using the rCRISS25 response at week 52. Safety and tolerability will also be closely monitored. The study involves regular visits for clinical evaluations, laboratory tests, and monitoring of disease activity and antibody status, with the total participation potentially lasting over two years including follow-up.

Researchers are investigating new treatment options for people with locally advanced or metastatic urothelial cancer, a type of bladder cancer. This trial focuses on comparing a medicine called sacituzumab tirumotecan (sac-TMT) with certain non-platinum chemotherapy drugs. The goal is to find out if sac-TMT can help people live longer after their cancer has worsened following previous treatments, including immunotherapy, chemotherapy, and targeted therapy. This is a Phase 3 randomized, open-label study. Participants receive either sacituzumab tirumotecan or one of the chemotherapy drugs vinflunine, docetaxel, or paclitaxel through intravenous (IV) infusions. Rescue medications may also be given to manage side effects, based on the investigator’s judgment and approved treatment guidelines. The study compares these treatments to evaluate their effects on the cancer and survival. During the trial, participants will be closely monitored with regular assessments to measure overall survival, the main outcome of the study, over about 40 months. Researchers will check participants' health, cancer progression, and organ function, and collect tumor tissue samples when possible. Safety and side effects will be tracked throughout the study to understand the treatments’ impacts and support participant well-being.

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 conducting a Phase Ib/II clinical trial to assess the safety, effectiveness, and how the body processes TQB3909 tablets combined with azacitidine in adults with myeloid malignancies, which include diseases like acute myeloid leukemia and myelodysplastic syndromes. The study aims to evaluate how well patients tolerate this combination and its impact on their condition. Participants will receive TQB3909, a protein inhibitor, along with azacitidine, a cytidine nucleoside analogue. The treatment is administered as tablets, and the study is open-label and multi-center. The trial focuses on monitoring adverse events for up to 24 weeks and measuring remission rates within 4 weeks after starting treatment. During the study, participants will undergo various evaluations to track safety and treatment response, including monitoring for side effects and laboratory tests. Researchers will record the incidence and severity of any adverse events and assess the rate of complete remission or remission with partial blood recovery. Participants must be adults aged 18 years or older and will be followed closely for up to 24 weeks to ensure safety and effectiveness of the treatment combination.

Researchers are conducting a multicenter, randomized, double-blind, placebo-controlled phase II clinical trial to evaluate the efficacy and safety of TQH2929 injection in patients experiencing acute flare-ups of generalized pustular psoriasis (GPP). The study aims to provide evidence on how well TQH2929, a humanized monoclonal antibody, works in managing this severe skin condition. A total of 36 patients will participate in the trial. Participants will receive either TQH2929 injections or a placebo, with the placebo containing no active substance. The treatment is administered through injection, and all subjects will use either the study drug or placebo during the trial period. This setup allows researchers to compare outcomes between the two groups under controlled conditions. During the study, participants will be closely monitored through visits and procedures to assess treatment effects and safety. Researchers will measure outcomes such as the percentage of patients achieving a pustule score of zero after one week of treatment. Female participants of childbearing age must agree to use contraception during the study and for six months afterward. The trial will also include safety monitoring for infections, immune status, and other health factors over the course of participation.

Researchers are evaluating the safety and effectiveness of TQB3909 tablets in patients who have recurrent or refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL). This phase Ib/II clinical trial focuses on patients diagnosed according to specific criteria and aims to understand how well this treatment works and how safe it is for this population. The study investigates TQB3909, a drug designed to inhibit the B-cell lymphoma-2 (BCL-2) protein. Participants will receive TQB3909 tablets as part of the treatment regimen. The trial includes monitoring for side effects and disease response over time. The study will measure the recommended phase II dose and assess remission rates through evaluations conducted up to 34 months. Participants will be involved in assessments that include monitoring for adverse events, serious adverse events, and abnormal laboratory results. These will be tracked for up to 34 months to evaluate safety and treatment impact. The study also includes imaging tests for measurable lesions and pregnancy testing for women of childbearing potential. Overall, the trial may last up to nearly three years, with ongoing safety and effectiveness evaluations throughout.

Researchers are evaluating IBI343, a new investigational drug, in a Phase Ia/Ib, multicenter, open-label study involving participants with locally advanced unresectable or metastatic solid tumors. The study aims to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of IBI343. Participants include those with various solid tumors who have failed or are intolerant to standard therapies, and the study is conducted across multiple countries including China, Australia, and the US. The study includes several parts, including dose escalation, dose expansion, dose optimization, and combination therapy cohorts. IBI343 is administered intravenously every 21 days or every 14 days depending on the study part. Combination therapies with chemotherapy regimens such as FOLFIRINOX/mFOLFIRINOX and mFOLFOX are included in certain cohorts. The study has an initial safety lead-in phase to confirm tolerability, followed by randomized dose optimization stages to determine the recommended Phase 3 dose. Treatments are given in cycles, with specific dosing schedules for each drug involved. Participants will undergo regular assessments including physical exams, vital sign monitoring, laboratory tests, and imaging to measure tumor response based on RECIST criteria. Researchers will track adverse events, dose-limiting toxicities, and treatment-emergent side effects up to 90 days after the last administration, with some outcome measures followed for up to 2 years. The study focuses on determining the objective response rate and safety profile of IBI343 while monitoring participant health and treatment effects throughout the study duration.

Researchers are evaluating the long-term safety and effects of nerandomilast in people with idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF) who have previously completed treatment with nerandomilast in earlier studies. The study aims to understand how well participants tolerate nerandomilast over time, and whether it helps improve lung function, delays symptom worsening, reduces hospital visits, or impacts survival. This is a Phase 3 open-label extension trial. Participants take nerandomilast tablets daily for up to 1 year and 10 months while continuing their usual pulmonary fibrosis treatments. The study follows an open-label design where all participants receive nerandomilast. There are no placebo or comparator groups in this extension phase. Throughout the study, participants regularly visit their doctors for health assessments and lung function tests. Doctors monitor any health problems or side effects experienced during treatment. The main outcome measured is whether participants experience any adverse events up to the final follow-up visit, which occurs at week 99. This close monitoring helps evaluate the long-term safety and potential benefits of nerandomilast in this patient group.