Cang Zhou Shi

Researchers are evaluating the effectiveness and safety of B001 injection in patients who have neuromyelitis optica spectrum disorder NMOSD and test positive for aquaporin-4 antibodies. This condition involves recurrent attacks affecting the nervous system. The study is a multicenter, randomized, double-blind, placebo-controlled trial conducted in phases II and III to understand how well B001 works and how safe it is for these patients. Participants will receive intravenous doses of either B001 or a placebo on Day 1 and Day 15 during the randomized controlled period. The study includes two groups one receiving B001 injections and the other receiving placebo injections matching B001s schedule. The trial will extend over several years, monitoring patients closely for disease relapse and treatment side effects. During the study, participants will be regularly assessed for the time to their first NMOSD attack, changes in disability status, vision acuity, and opticospinal function. Researchers will also observe the annual relapse rate and document any adverse events. The trial includes safety monitoring for about three years to ensure comprehensive data collection on treatment impact and participant health.

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 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 dose-effect relationship of TQH3906 capsules compared to placebo in treating active Psoriatic Arthritis PsA. This Phase II, randomized, double-blind, placebo- and active drug-controlled clinical trial aims to measure the proportion of participants achieving a 20% improvement in arthritis symptoms by Week 12, using the American College of Rheumatology ACR20 criteria as the primary endpoint. Participants are randomly assigned to receive one of several oral treatments daily from Day 1 to Day 85 either 24 mg or 16 mg of TQH3906 capsules, placebo capsules matching TQH3906, or 5 mg tofacitinib citrate tablets. The treatments are administered in the morning while fasting, with tofacitinib also taken at bedtime. This study evaluates efficacy and safety across these groups over 12 weeks of treatment. During the study, participants are assessed at multiple timepoints for improvements in arthritis symptoms ACR20, ACR50, ACR70 and psoriasis severity PASI 75 and PASI 90. Blood samples are collected to evaluate drug levels and immune markers at baseline and Weeks 2, 4, 8, and 12. Safety is monitored continuously through adverse event reporting up to 28 days after the last dose. The total study duration per participant is approximately 12 weeks of treatment plus follow-up.

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.

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 safety, tolerability, and maximum tolerated dose of BPI-371153, a PD-L1 inhibitor, in patients with advanced solid tumors or relapsedrefractory lymphoma. This phase 1 open-label study aims to establish the recommended dose for further research and to understand how the drug behaves in the body and its anti-tumor activity. Participants will receive oral capsules of BPI-371153 once daily in 21-day treatment cycles. The study includes a dose escalation phase to find the maximum tolerated dose and a dose expansion phase where patients receive the recommended dose. Different patient groups include those with advanced non-small cell lung cancer, relapsed or refractory lymphoma, hepatocellular carcinoma, and other advanced solid tumors. During the study, participants will be monitored for adverse events, drug levels in the body, and tumor response over approximately 24 months. Researchers will assess tumor lesions using recognized criteria and evaluate PD-L1 expression levels. The study requires adequate organ function and performance status, with ongoing evaluation to ensure safety and determine the best dose for future studies.

Researchers are conducting a multicenter, randomized, double-blind, parallel-controlled phase I clinical study to compare HLX17 and US-sourced Keytruda in patients with resected non-small cell lung cancer, melanoma, or renal cell carcinoma. The study aims to evaluate how similar the pharmacokinetic profiles, efficacy, safety, and immune responses are between these two treatments in this patient population. Participants will receive either HLX17 or US-sourced Keytruda. Those in the HLX17 group will get 200 mg on Day 1 of every 3-week cycle for up to 12 months or until disease recurrence, death, new anti-tumor therapy, unacceptable toxicity, consent withdrawal, or study end. The Keytruda group will receive 200 mg every 3 weeks for 8 cycles 24 weeks, then switch to HLX17 on the same schedule until 12 months or similar conditions occur. During the study, participants will undergo various assessments including pharmacokinetic measurements such as drug concentration over time and at steady state, disease-free survival evaluation for up to 12 months, and monitoring for adverse events and laboratory abnormalities for up to 15 months. Safety follow-up includes vital signs, physical exams, ECGs, and immunogenicity evaluation. The total study duration includes treatment and safety monitoring phases.

Researchers are evaluating the appropriate dose and the safety, tolerability, and effectiveness of HLX43 combined with Serplulimab in patients with advanced lung cancer. This phase II randomized, open-label study focuses on patients with advanced non-small cell lung cancer NSCLC without actionable gene alterations and small cell lung cancer SCLC who have previously received immunotherapy and platinum-based chemotherapy. The aim is to better understand how these treatments work together in this patient group. Participants are randomly assigned to receive one of two doses of HLX43, an anti-PD-L1 antibody linked to a potent DNA topoisomerase I inhibitor, along with a fixed dose of Serplulimab, an anti-PD-1 antibody. Both medications are given by intravenous infusion every three weeks. Those who tolerate the treatment well and have controlled disease will continue receiving the combination every three weeks until disease progression, new anti-cancer therapy is started, intolerable side effects occur, death, or withdrawal of consent. During the study, participants will have regular assessments including tumor measurements according to RECIST 1.1 criteria, laboratory tests, and safety monitoring for adverse events. The main outcome measured is the overall response rate within 24 weeks, with additional measurements including progression-free survival up to 12 months and overall survival up to approximately 18 months. Follow-up for safety will continue up to 90 days after the last dose. The total duration of participation varies based on treatment response and tolerability.

Researchers are evaluating the effectiveness, safety, and tolerability of elecoglipron alone or combined with dapagliflozin compared with a placebo in adults with type 2 diabetes mellitus T2DM who are not adequately controlled by lifestyle management alone or who are on other background glucose-lowering medications. This Phase III study aims to understand how these treatments impact blood sugar control and related health factors. Participants will be randomly assigned to one of four groups elecoglipron at dose level 1 with dapagliflozin-matched placebo, elecoglipron at dose level 2 with dapagliflozin-matched placebo, a combination of elecoglipron at one of the studied doses with dapagliflozin, or matching placebos for both drugs. All treatments are taken orally once daily. The study uses a quadruple-blind design to compare these options over a treatment period lasting up to 40 weeks. During the study, participants will have their blood sugar levels measured by changes in Hemoglobin A1c HbA1c from baseline to week 40. Other assessments include body weight, blood pressure, and the time to start any additional rescue medication. Participants will attend regular visits for monitoring and safety evaluations throughout the study duration, which extends until the primary completion date in July 2028.