An Yang Shi

Researchers are evaluating the effectiveness and safety of TQB2102 for injection compared to a standard chemotherapy regimen called TCbHP in patients with HER2-positive breast cancer. This phase III, randomized, open-label, multi-center study focuses on neoadjuvant treatment, which is therapy given before surgery. The study aims to measure the total pathological complete response and other outcomes such as event-free survival and overall survival. Participants receive either TQB2102 for injection at 6 mgkg by intravenous infusion every 3 weeks for 8 cycles or a combination of Trastuzumab, Pertuzumab, Docetaxel, and Carboplatin given intravenously every 3 weeks for 6 cycles. The study monitors participants throughout the treatment period and collects data on tumor response and side effects. During the study, participants will undergo assessments including tumor response evaluations by independent review and investigators, safety monitoring for adverse events, and laboratory tests. Follow-up will continue for up to 50 months after the start of the study to observe long-term outcomes. Participants are expected to comply with contraceptive use requirements and attend all scheduled visits for treatment and evaluations.

Researchers are studying the safety and effectiveness of T3011, a herpesvirus injection, combined with PD-1PD-L1 inhibitors in adults with advanced solid tumors. This clinical trial aims to evaluate how well this combination treatment works and how well patients tolerate it, with the study sponsored by Shanghai Pharmaceuticals Holding Co., Ltd. It is a Phase IbIIa trial conducted at multiple centers. Participants will receive T3011 injected directly into tumors every two weeks, along with PD-1PD-L1 inhibitors given by intravenous infusion at a dose of 3 mgkg also every two weeks. Different dose levels of T3011 high, middle, and low are being tested to assess safety and initial effectiveness. The study does not include a placebo group and is open-label, meaning both researchers and participants know the treatments being given. During the study, participants will be closely monitored for side effects and treatment responses over about two years. Researchers will measure outcomes such as the rate of treatment-related adverse events, objective response rate, disease control rate, duration of remission, progression-free survival, and overall survival. Participants will undergo regular assessments including physical exams, laboratory tests, and imaging to track their progress and safety throughout the trial.

Researchers are evaluating YL205, a drug given by intravenous infusion, in patients with advanced solid tumors. This multicenter, open-label phase III study in China aims to assess the safety, tolerability, pharmacokinetics how the drug moves through the body, and preliminary effectiveness of YL205. Eligible patients have advanced solid tumors that overexpress Napi2B and include cancers such as ovarian, non-squamous non-small cell lung, renal cell, and endometrial cancer. Participants receive YL205 as a lyophilized powder reconstituted for intravenous infusion at a dose of 160 mg per vial. Treatment is given once every three weeks in cycles, with dose levels adjusted during different study phases dose escalation phase Ia, dose expansion phase Ib, and cohort expansion phase II. The study evaluates at least two dose levels and the recommended phase 2 dose RP2D. Throughout approximately 36 months, participants are closely monitored for dose-limiting toxicities, treatment-emergent adverse events, and serious adverse events. Researchers assess tumor response using RECIST v1.1 criteria, including overall response rate, disease control rate, duration and depth of response, progression-free survival, and overall survival. Pharmacokinetic parameters like AUC, Cmax, and half-life are also measured. Patients undergo tumor sampling and radiological evaluations to track treatment effects and safety.

Researchers are evaluating the efficacy and safety of TQB3702 tablets combined with immunochemotherapy for treating B-cell lymphoma. This Phase II clinical trial focuses on patients diagnosed with specific types of B-cell lymphoma, including relapsed or refractory indolent B-cell lymphoma and diffuse large B-cell lymphoma DLBCL. The study aims to assess how well this combination therapy works and its overall safety. Participants will receive TQB3702 tablets at a dose of 200 mg every 4 weeks as one treatment cycle. Alongside this, they will undergo chemotherapy cycles every 3 or 4 weeks, with a total of 6 to 12 cycles of combination therapy. The chemotherapy regimen is designed to inhibit tumor cell growth, suppress DNA synthesis, induce cancer cell death, support immune function, and prevent new blood vessel formation that supports tumors. During the trial, participants will be closely monitored for treatment response and safety. Researchers will measure overall and complete response rates up to 2 years, as well as adverse events, progression-free survival, duration of response, and overall survival up to death from any cause. The study includes assessments from baseline through combination therapy completion and follow-up periods lasting up to 2 years. This comprehensive monitoring helps understand both the immediate and longer-term effects of the treatment.

Researchers are evaluating TQB6411 injection, an antibody-conjugated drug that targets EGFR and c-Met proteins on tumor cells, in people with advanced malignant tumors. The study aims to assess how well patients tolerate the treatment, understand how the drug moves through the body, and observe early signs of its effects. This phase I clinical trial focuses on patients who have advanced cancer and have not responded to or cannot tolerate standard treatments. TQB6411 is given by intravenous injection every three weeks, with doses ranging from 0.8 mgkg to 8 mgkg at the start of each treatment cycle. The antibody in TQB6411 binds to cancer cells to block important growth signals, and then releases toxins inside the cells to cause DNA damage and cell death. The study includes a dose escalation stage to find the maximum tolerated dose and a dose expansion stage for specific tumor types such as advanced non-small cell lung cancer and metastatic colon cancer. Participants will have regular blood tests and tumor imaging to monitor safety and treatment effects for up to 24 months. Researchers will track dose-limiting toxicities, adverse events, drug levels in the blood, tumor response rates, and survival outcomes. Women of childbearing potential must use effective contraception during and for six months after the study. The trial includes careful monitoring to assess the bodys reaction to the drug and to gather information for future studies.

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 efficacy and safety of TQB6411 for Injection in adults with advanced lung cancer. This phase IbII clinical trial focuses on patients aged 18 to 75 years who have lung cancer confirmed by histology or cytology and meet specific health criteria. The study is sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. and aims to determine the recommended phase II dosage and measure response rates over time. Participants will receive TQB6411 for Injection as the treatment, administered in cycles every 21 or 28 days. The study includes monitoring for response rates, disease control, duration of relief, progression-free survival, overall survival, adverse events, and the presence of anti-drug antibodies. Blood samples will be collected at specified cycles and timepoints before and after dosing to assess drug levels and immune responses. During the study, participants will be evaluated for tumor response using recognized criteria and undergo laboratory tests to monitor safety and drug effects. The study duration includes follow-ups up to three years for overall survival assessment. Participants will be regularly monitored for side effects and treatment efficacy to ensure comprehensive data collection throughout the trial period.

Researchers are evaluating the efficacy and safety of TQH3906, a Tyrosine Kinase 2 TYK2 inhibitor, in treating systemic lupus erythematosus SLE, an autoimmune disease. This randomized, double-blind, placebo-controlled, multi-center Phase II clinical trial aims to assess how well TQH3906 works and its safety profile in adults diagnosed with SLE based on established criteria. The study is sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Participants are randomly assigned to one of three groups 16 mg TQH3906 capsule, 24 mg TQH3906 capsule, or placebo. All treatments are taken orally once daily for 48 weeks. The trial compares these doses to placebo to understand TQH3906s impact on disease activity. The study uses a parallel design and includes a quadruple masking method to keep participants and researchers unaware of group assignments. During the study, participants undergo regular assessments including clinical evaluation of disease activity using the Systemic Lupus Erythematosus Responder Index 4 SRI-4, lupus activity indices, and joint assessments up to week 48. Safety is monitored throughout, and background lupus medications must remain stable during the trial. The primary outcome measure is the percentage of participants achieving SRI-4 response by week 32, with additional secondary measures assessing remission, low disease activity, and symptom improvements. Participation lasts up to 48 weeks with scheduled visits and monitoring.

Researchers are evaluating the safety and tolerability of DB-1303BNT323 in adults with advanced or metastatic solid tumors that express HER2. This Phase 12a trial focuses on patients with tumors that are advanced, unresectable, recurrent, or metastatic and have limited or no standard treatment options. The study aims to identify the best dose and explore early signs of effectiveness in a variety of HER2-expressing cancers. The trial has two parts an initial dose-escalation phase using an accelerated titration followed by a classic 33 design to find the maximum tolerated dose MTD or recommended Phase 2 dose RP2D, and a dose-expansion phase to further assess safety, tolerability, and potential effects at the established dose. Participants receive DB-1303BNT323 by intravenous infusion once every three weeks Q3W at various dose levels. Some groups are randomized to receive different dose levels or combinations with other drugs like Pertuzumab, Ritonavir, or Itraconazole to study drug interactions and responses. During the study, participants will have regular assessments including monitoring for dose-limiting toxicities, adverse events, and serious adverse events using standard criteria up to about one year after treatment. Researchers will also evaluate tumor responses using RECIST 1.1 criteria and collect pharmacokinetic and pharmacodynamic data. Other evaluations include heart function tests, organ function, and overall health status. The study duration varies per participant, with follow-up visits extending up to one year post-treatment to monitor safety and treatment effects.

Researchers are evaluating the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary efficacy of LBL-024 in patients with advanced malignant tumors in a phase III clinical study. This study includes patients who have failed previous standard treatments, lack standard treatment options, or are not suitable for such treatments. The trial consists of two parts a phase IIIa dose escalation and pharmacokinetic expansion phase, and a phase IIb pivotal single-arm clinical study. Participants receive LBL-024 injections at the maximum tolerated dose every three weeks. The phase IIIa part focuses on dose escalation, safety, and preliminary efficacy, while the phase IIb part serves as a single-arm registry study to further assess the treatment. The study evaluates the drugs pharmacokinetic characteristics and immune response throughout treatment. During the study, participants are closely monitored for dose-limiting toxicities within three weeks of the first dose and maximum tolerated dose completion. Researchers assess objective response rate, adverse events, immunogenicity, disease control rate, and progression-free survival. Follow-up visits occur up to 30 days after treatment discontinuation or withdrawal. The total study duration extends until December 2026.