Gan Zhou Shi

Researchers are evaluating the safety, effectiveness, and cellular pharmacokinetics of GT719 Injection in adults with relapsed or refractory CD19-positive B-cell non-Hodgkin lymphoma and B-acute lymphoblastic leukemia. This early phase 1, prospective, single-arm, open-label clinical trial will enroll 34 participants to assess these outcomes in this specific group of hematological malignancy patients. Participants will receive the GT719 Injection, a biological treatment, during the dose escalation and expansion phases of the study. The study involves administering the investigational treatment and monitoring its effects, without a comparator group. The detailed dosing schedule and treatment delivery methods are part of the trial design but are not further specified in the provided information. During the study, participants will be closely monitored for safety by tracking adverse events and dose-limiting toxicities over 28 days. Researchers will assess participants' responses and monitor their health through physical evaluations and laboratory tests. The total duration of participation and additional follow-up procedures are not specified in the available data.

Researchers are evaluating the safety and effectiveness of LBL-024 combined with other drugs in treating patients with advanced non-small cell lung cancer (NSCLC), a type of advanced solid tumor. This open-label, multicenter, phase II study includes four different patient groups to assess this combination therapy. The goal is to understand how well these treatments work together and their safety in this patient population. The study involves a safety run-in period for each group, where a small number of patients receive the LBL-024 combination to monitor tolerability over 21 days. Depending on the safety results, some groups will continue treatment with LBL-024 combined with other drugs such as pemetrexed, or LBL-024 alone for maintenance therapy. Patients are randomized into different arms to receive various combinations of intravenous infusions including LBL-024, docetaxel, bevacizumab, pemetrexed disodium, paclitaxel, and carboplatin. Participants will be closely monitored throughout the study for tumor response using established criteria and safety assessments. Researchers will track the objective response rate from the time patients consent through 28 days after stopping the study drug or before starting new anti-tumor treatment. The study will enroll up to 230 subjects aged 18 to 75 years and includes regular evaluations, laboratory tests, and follow-ups to ensure safety and measure treatment effects.

Researchers are evaluating TQB2102, an antibody-drug conjugate designed to target tumor cells with a potent drug payload, for its effectiveness and safety in treating locally advanced or metastatic non-small cell lung cancer (NSCLC) with HER2 gene abnormalities. This Phase 2 study focuses on patients whose cancer is either inoperable or has recurred and who have not responded to previous standard treatments. The goal is to assess the overall response rate up to 8 months after starting treatment. Participants may receive TQB2102 alone or in combination with Benmelstobart injection, a monoclonal antibody targeting PD-L1. TQB2102 combines a humanized antibody against HER2 with a topoisomerase I inhibitor payload, aiming to specifically attack cancer cells. The treatments are administered by injection, and the study examines their safety and effectiveness in this patient population. During the study, participants will be monitored closely with evaluations including tumor measurements based on standard criteria. Researchers will track treatment responses and any side effects to determine safety and overall benefit. The study includes adults aged 18 to 75 years with specific performance status and survival expectations, and it also requires contraception use for participants of childbearing potential. The total duration includes baseline through up to 8 months of treatment response assessment.

Researchers are conducting a Phase I trial to study BB-1705, a drug made of an engineered antibody linked to a cancer-fighting agent, in adults with locally advanced or metastatic solid tumors that have not responded to standard treatments. The study aims to evaluate the safety, tolerability, the maximum tolerated dose (MTD), maximum administered dose (MAD), recommended Phase 2 dose (RP2D), pharmacokinetics, and preliminary anti-tumor activity of BB-1705. The study includes two parts: Phase Ia dose escalation and Phase Ib cohort expansion. During Phase Ia, participants receive increasing doses of BB-1705 to identify the safest and most effective dose. Phase Ib involves giving one or more recommended doses to additional patients to further assess safety and early treatment effects. Treatment cycles last 21 days, and dosing frequency is based on these cycles. Participants will undergo regular assessments including monitoring for side effects and serious adverse events for up to two years. Researchers will track dose-limiting toxicities during the first 21-day cycle. Evaluations include safety tests, blood samples for drug levels, tumor measurements, and questionnaires about health status. The study monitors patients closely through all treatment cycles and follows them for long-term safety and response.

Researchers are studying the gut microbiome in people with several serious chronic diseases in China, including various cancers, hypertension, epilepsy, and kidney disease. The study aims to better understand the differences and similarities in gut microbiome patterns linked to these diseases and different regions, and how these patterns affect microbiome-based diagnostic tests. This work is important because past research has shown links between microbial imbalances and disease, but variability between studies has made it hard to draw clear conclusions. This observational study will recruit 500 patients diagnosed with each target disease and 500 healthy control participants matched by age and sex. Researchers will collect detailed information about participants' demographics, lifestyle, diet, medications, and health status. Biological samples including feces, saliva, urine, and blood will be collected for analysis. There is no active treatment or intervention; the study focuses on characterizing the microbiome and related health data. Participants will undergo assessments of their medical history and lifestyle, with sample collections to analyze microbiome and biochemical markers. Researchers will measure the baseline microbiome to identify disease-associated signatures. The study requires participants to be aged 18 to 75 and to have lived in the hospital's province for at least three years. Safety monitoring is observational, with no study treatments given. The total participant involvement includes data and sample collection for cross-sectional analysis.

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.

This study is an open-label phase II clinical study to explore the reasonable dosage and to evaluate the efficacy, safety and tolerability of HLX43 (Anti-PD-L1 ADC) in patients with recurrent/metastatic Nasopharyngeal Carcinoma (NPC) who failed or are intolerant to second-line therapy. In this study, eligible subjects will be randomized at 1:1:1 ratio, and the patients will be administered with HLX43 at three different doses via intravenous infusion.

Researchers are evaluating the safety and effectiveness of MC2-01 cream in treating Chinese adults aged 18 years and older with plaque psoriasis affecting the body (trunk and/or limbs). This phase 3, multi-center, randomized, investigator-blinded study compares MC2-01 cream to both calcipotriol and betamethasone dipropionate gel and a vehicle cream. The study includes screening, treatment, and safety follow-up periods to thoroughly assess the treatment's impact. Participants receive one of three treatments: MC2-01 cream (containing calcipotriene and betamethasone dipropionate), CAL/BDP gel (calcipotriol and betamethasone dipropionate gel), or a vehicle cream without active ingredients. Treatments are applied during the treatment period following the study protocol. The design allows comparison of MC2-01 cream’s efficacy and safety against the gel and vehicle. During the study, participants undergo evaluations including physician assessments using the Physician's Global Assessment (PGA) to measure treatment success on the body after 8 weeks. Researchers monitor safety and treatment response through scheduled visits covering screening, treatment, and follow-up phases. Participation involves completing visits as required by the protocol to ensure comprehensive data collection over the study duration.

Researchers are evaluating the effectiveness and safety of combining RC108 with Furmonertinib compared to using Furmonertinib alone for first-line treatment in adults aged 18 to 75 years with EGFR-mutated, MET-positive, unresectable locally advanced or recurrent metastatic non-small cell lung cancer (NSCLC). This Phase II trial aims to provide new options for patients whose cancer cannot be removed by surgery or treated with radiation. The study also looks at how the body processes RC108 and whether the immune system reacts to it when given with Furmonertinib. Participants will be randomly assigned to receive either the combination of RC108 and Furmonertinib or Furmonertinib alone. Treatments are taken as medications, and the study monitors patients over time to compare their responses. The study includes patients who have not received previous systemic therapy for their advanced or recurrent disease. Tumor tissue samples are collected for testing, and participants must have measurable cancer lesions. During the study, participants will undergo regular assessments including physical exams, performance status evaluation, and tumor measurements according to RECIST criteria. Researchers will track the objective response rate over 24 months to determine how well the treatments work. Safety will be closely monitored along with patient survival and overall health. Participants are expected to use effective contraception if of childbearing potential and will be followed for treatment effects and side effects throughout the study period.

Researchers are evaluating the safety, tolerability, and effectiveness of common chemotherapy drugs—cyclophosphamide, doxorubicin, epirubicin, fluorouracil, and methotrexate—in women with infiltrating ductal carcinoma (IDC) of the breast. IDC is the most frequent type of breast cancer, often spreading beyond the milk ducts into surrounding tissue and possibly to lymph nodes or other body areas. This phase I, randomized, multi-center trial aims to test these chemotherapy treatments in women scheduled for surgery for IDC breast cancer to better understand their impact and potential benefits. Participants receive either one chemotherapy drug alone or a combination of two drugs (from the five mentioned), administered intravenously on the 1st and 8th days of each 28-day cycle, for a total of six cycles. Treatment occurs 30 to 60 days before surgery, followed by a 30-day break before the surgical procedure. A placebo group is also included, receiving a standard placebo used in clinical oncology instead of chemotherapy drugs. The study collects tumor and blood samples to assess treatment effects and correlates these with patient outcomes over time. During the study, participants undergo regular monitoring including assessments of side effects, blood tests to evaluate blood cell counts and liver function, and imaging tests before surgery. Researchers measure the occurrence of treatment-related adverse events over six months as the primary outcome. They also track survival rates, tumor response, and potential damage to the tumor environment to understand how these chemotherapy regimens affect disease progression and patient health. Participants are followed from treatment initiation through surgery and beyond to assess both short- and long-term effects.