Xinxiang

This research aims to evaluate the preliminary anti-tumor effects and safety of Hemay181 in adults with advanced solid tumors who have not responded to standard treatments or have no effective standard therapy available. It is an open-label Phase I clinical study focusing on patients with measurable tumors confirmed by pathology and who meet specific health and treatment history criteria. The study assesses the treatment's impact until tumor progression or death, with monitoring lasting up to 100 months. Participants receive Hemay181 through intravenous infusion once every three weeks. The study includes patients with a good performance status and adequate recovery from prior treatments. Women of childbearing potential must agree to use effective contraception during the study and for six months afterward. The treatment is administered in cycles, and patients are closely monitored for response and safety throughout the study. During the study, participants undergo regular evaluations including imaging scans such as CT or MRI to measure tumor changes. Researchers track the effectiveness of Hemay181 by recording the time until tumor progression or death. Safety is monitored continuously, and participants are followed for an extended period to assess long-term outcomes. The total duration of involvement depends on the patient's response and survival, with ongoing assessments to ensure safety and collect data on treatment effects.

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 investigating new treatments for rheumatoid arthritis (RA), a condition where current therapies like methotrexate (MTX) may not fully control symptoms for many people. This Phase 2b study evaluates a medicine called tulisokibart to see if it can better reduce RA symptoms in individuals already taking MTX. The trial aims to determine if one or more doses of tulisokibart work better than a placebo, which looks like the medicine but contains no active drug. The study includes a 12-week period where participants receive either tulisokibart or a placebo by subcutaneous injection while continuing their MTX treatment, which can be given by injection or orally. Following this, there is a long-term extension lasting 116 weeks, composed of a 44-week main extension and a 72-week optional extension, to further assess the medication's effects and safety over time. Participants will undergo assessments to measure treatment response, including the American College of Rheumatology 20% response criteria at week 12 to gauge symptom improvement. Throughout the study, researchers will monitor for safety and effectiveness, with evaluations extending through the long-term extension periods, totaling over two years of participation.

Researchers are evaluating a combination treatment using BNT326 and BNT327 in adults with advanced or metastatic non-small cell lung cancer (NSCLC), including those with relapsed, progressive, or treatment-nafve disease. This multi-site, open-label study includes dose-finding and dose-expansion phases to investigate the safety, tolerability, and preliminary effectiveness of this combination therapy. The study targets patients whose tumors are advanced, metastatic, or recurrent with no curative treatment options available and includes participants with different genomic alterations. The study is divided into several parts: Part 1 is a dose escalation phase to find safe dose levels of BNT326 with BNT327; Part 2a expands the dose to further evaluate safety and initial efficacy; Part 2b focuses on dose optimization and understanding the contributions of each component. Participants receive intravenous infusions of BNT326 and BNT327, with some cohorts possibly receiving additional treatments such as pembrolizumab or standard chemotherapy. Treatment continues until disease progression, unacceptable side effects, withdrawal, or a maximum of 24 months. Dose levels for certain cohorts are determined based on earlier phase data, and some parts include randomization to different treatment groups. Participants undergo a screening period before starting treatment, followed by treatment, safety follow-up, efficacy follow-up, and long-term survival monitoring, totaling about 36 months. Researchers assess dose-limiting toxicities within the first 21 days of treatment and monitor adverse events, treatment interruptions, and objective response rates up to 36 months. Tumor measurements, safety labs, imaging, and patient health status are regularly evaluated. The study tracks tolerability and efficacy while ensuring participant safety throughout treatment and follow-up.

Researchers are evaluating the safety, tolerability, how the body processes the drug, and early antitumor effects of BG-C137, an antibody-drug conjugate targeting FGFR2b, alone and combined with other anticancer drugs in people with advanced solid tumors. This study includes two phases: Phase 1a focuses on dose escalation and safety, while Phase 1b involves dose expansion. The trial is sponsored by BeOne Medicines, formerly BeiGene. Participants receive BG-C137 through intravenous infusion. In combination groups, anticancer agents are given either intravenously or orally. Phase 1a includes monotherapy dose escalation, safety expansion, and combination dose confirmation and safety expansion. Phase 1b focuses on dose expansion. The study will determine the maximum tolerated dose, recommended doses for expansion, and overall response rates over approximately two years. During the study, participants will undergo evaluations including safety monitoring for adverse events, pharmacokinetic and pharmacodynamic assessments, and tumor response measurements using RECIST v1.1 criteria. Researchers will collect tumor tissue samples to assess FGFR2b expression and other biomarkers. Participants' physical function, organ health, and prior treatments will be reviewed. The total study duration may last up to about two years, with close monitoring of side effects and treatment effects throughout.

Researchers are evaluating the safety, tolerability, and effectiveness of RC278 in treating patients with locally advanced unresectable or metastatic malignant solid tumors. This Phase I/II clinical trial aims to find the maximum tolerated dose and recommended dose for Phase 2, while also assessing side effects and tumor response. Participants will receive RC278 through intravenous infusion every three weeks. Treatment will continue until unacceptable side effects occur, the disease progresses, or the participant withdraws. The study includes a dose escalation period to determine optimal dosing and an evaluation period to monitor effects at the recommended dose. Throughout the 24-month study, participants will undergo regular monitoring for dose-limiting toxicities, adverse events, and effectiveness of treatment using imaging and clinical assessments following RECIST v1.1 criteria. Safety and response rates will be closely tracked to inform future research and treatment strategies.

Researchers are evaluating the safety and tolerability of DB-1311/BNT324 in adults with advanced or metastatic solid tumors in this Phase 1/2a trial. The study includes a dose-escalation phase to find the maximum tolerated dose and recommended Phase 2 dose, followed by a dose-expansion phase to confirm safety and explore effectiveness, including in prostate cancer patients receiving novel hormone therapy. Additionally, a sub-study will assess the effects of other drugs on DB-1311's behavior in the body. During Phase 1, participants receive increasing doses of DB-1311 administered intravenously using an accelerated titration and classic 3+3 design to determine safe dosage levels. Phase 2a expands on this to further evaluate safety and tolerability, with DB-1311 given alone or combined with hormone therapy drugs such as enzalutamide or abiraterone for prostate cancer. The study also investigates drug interactions with lopinavir/ritonavir and itraconazole. Treatment schedules and dosing details follow the study protocol at multiple centers. Participants will undergo various assessments including safety labs, vital signs, electrocardiograms, heart function tests, and performance status evaluations up to approximately one year after treatment. Researchers will monitor treatment-related toxicities, serious adverse events, and response rates. The involvement includes tumor biopsies for biomarker analysis and adherence to follow-up visits. The total study duration varies by phase, with ongoing safety and efficacy monitoring throughout.

Researchers are evaluating the safety and effectiveness of two antibiotic treatments, omadacycline and moxifloxacin, in Chinese adults with community-acquired bacterial pneumonia (CABP). This Phase 3b study is designed as a bridging trial to confirm whether omadacycline works as well as moxifloxacin in this specific population, building on results from a global CABP trial. Participants will receive either omadacycline or moxifloxacin through intravenous or oral routes. The treatments are given as a course, with details on dosing schedules not specified. The study compares these two drugs directly to assess their clinical efficacy and safety in treating CABP. During the study, participants will be monitored and evaluated for their clinical response at 18 months after therapy. Researchers will assess symptoms, vital signs, and overall health related to pneumonia to determine treatment success. Safety and efficacy data collected throughout the study will help understand how well each drug performs in this patient group.

Researchers are investigating the similarity in pharmacokinetic (PK) profile, effectiveness, safety, and immune response of HLX17 compared to US-sourced Keytruda® in patients who have had surgery for non-small cell lung cancer, melanoma, or renal cell carcinoma. This Phase I, multicenter, randomized, double-blind study aims to compare these two treatments in people with these resected solid tumors to better understand their performance and safety profiles. Participants will receive either HLX17 or US-sourced Keytruda®, each given at a dose of 200 mg on the first day of every 3-week cycle. The study is designed with parallel groups, where each participant receives one of the treatments across multiple cycles. The dosing schedule continues through six cycles, and the two treatments are directly compared under controlled conditions. Throughout the study, participants will be monitored closely with various assessments including laboratory tests and evaluations of organ function to ensure safety. The main outcomes measured are drug exposure over time from the first dose to 21 days after the initial and sixth doses. Participants are expected to have a performance status of 0 and a life expectancy of at least 12 weeks. Safety and immunogenicity will also be evaluated, with follow-up to monitor any side effects or immune responses during and after treatment.

This is a phase I/II, multicenter, open-label, first-in-human study of FWD1802 in patients with locally advanced or metastatic breast cancer that is estrogen receptor (ER)-positive/human epidermal growth factor receptor 2 (HER2)-negative (Phase II: restricted to patients with ESR1-mutated). It consists of three parts: the FWD1802 dose-escalation phase (Phase I Part A), the FWD1802 dose-expansion phase (Phase I Part B), and the dose-expansion study of FWD1802 in patients with ESR1 mutations (Phase II study). Each study phase includes a screening period (up to 4 weeks), a treatment period (maximum treatment duration of 2 years; continuation beyond 2 years is permitted if the investigator judges the subject is still benefiting, with agreement from both the investigator and sponsor), and a follow-up period. The Phase II study includes a pre-screening period; patients with unknown mutation status may undergo testing that includes ESR1 mutation status prior to the screening period. Phase I Part A is the FWD1802 dose-escalation study: A dose-escalation trial using a combination of an "accelerated titration" design and a "3+3" design is planned, with a maximum of 27 subjects to be enrolled. The Safety Monitoring Committee (SMC) will evaluate pharmacokinetic (PK), pharmacodynamic (PD), efficacy, and safety data to guide the determination of potentially effective doses for Part B and the Phase II study. Phase I Part B is the FWD1802 dose-expansion study: Based on safety, PK, PD, and other data obtained from Part A, 2 to 4 dose cohorts will be selected for further exploration of FWD1802's PK profile and the recommended phase 2 dose (RP2D). Each dose cohort will be expanded to include up to 10 subjects (including subjects from the corresponding dose cohort in Part A). The SMC will decide which dose cohorts to expand and the timing of expansion based on information obtained from Part A. Dose expansion may proceed concurrently with the dose-escalation phase, within dose ranges already confirmed as safe by the SMC. The Phase II study is cohort expansion study targeting the population with ESR1 mutations: Enrolled subjects will have ER-positive, HER2-negative breast cancer with ESR1 mutations. One to two dose levels will be selected for exploration, with each dose level enrolling no more than 30 subjects, for a maximum total enrollment of 60 subjects.