An Yang Shi

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 safety and initial effectiveness of T3011, a herpesvirus injection, combined with PD-1/PD-L1 inhibitors in adults with advanced solid tumors. This phase Ib/IIa clinical trial focuses on patients who have measurable tumors and a good performance status, aiming to understand how well this combination treatment is tolerated and how it impacts tumor response. Participants receive T3011 through injections directly into the tumor every two weeks. Alongside this, PD-1/PD-L1 inhibitors are given by intravenous infusion at a dose of 3 mg/kg every two weeks. The study includes high, middle, and low doses of T3011 to monitor different effects. This multi-center, single-arm trial does not include a comparison group and spans roughly two years. Throughout the study, researchers will monitor treatment-emergent side effects and measure how tumors respond to the therapy over about two years. Participants will undergo regular laboratory tests and pregnancy tests for women of childbearing potential. Safety assessments, including monitoring for adverse events and overall treatment tolerability, will be conducted. The study requires participants to comply with all procedures and follow-up visits during this period.

This study is a multicenter, open-label, phase I/II study of YL205 in China to evaluate the safety, tolerability, PK characteristics and preliminary efficacy of YL205 in the following selected patients with advanced solid tumors.

Researchers are evaluating the safety and effectiveness of TQB3702 tablets combined with immunochemotherapy in treating B-cell lymphoma. This phase II clinical trial focuses on patients with specific types of B-cell lymphoma, including relapsed or refractory indolent B-cell lymphoma and diffuse large B cell lymphoma (DLBCL). Participants must meet diagnostic criteria according to the 2022 World Health Organization standards and have measurable disease. The treatment involves administering TQB3702 tablets, a tyrosine kinase inhibitor, together with a chemotherapy regimen designed to inhibit tumor cell growth, suppress DNA synthesis, induce cancer cell death, enhance immune function, and inhibit blood vessel formation that supports tumors. The study monitors patients throughout the treatment period to assess the combined therapy's impact on lymphoma. Participants will be closely observed during the study to evaluate their response to treatment, including overall response rate and complete response rate over a period of up to two years. Researchers will perform regular assessments of organ function, tumor measurements, and safety monitoring. Women of childbearing potential and men must agree to use contraception during the study and for six months afterward. The trial includes follow-up to ensure participant safety and treatment effectiveness over time.

Researchers are evaluating TQB6411 for injection, an antibody-drug conjugate (ADC) designed to treat advanced malignant tumors by targeting EGFR and c-Met on tumor cells. This drug binds to these receptors to block their signaling pathways, delivering toxins that cause DNA damage and cell death. The trial is a Phase I clinical study assessing the tolerance, pharmacokinetics, and preliminary efficacy of TQB6411 in patients with advanced cancers. Participants will receive TQB6411 administered intravenously. The antibody portion targets tumor cells expressing EGFR and c-Met, leading to internalization and toxin release inside the cells. This process aims to damage and kill tumor cells. The study includes dose escalation to determine the maximum tolerated dose and a dose expansion phase for specific tumor types such as advanced non-small cell lung cancer, metastatic colon cancer, esophageal squamous cell carcinoma, and nasopharyngeal carcinoma. During the study, participants will undergo various assessments including monitoring for dose-limiting toxicities, adverse events, and determination of the recommended Phase II dose over up to 24 months. Safety, pharmacokinetics, and tumor response evaluations will be conducted, alongside laboratory tests and tumor tissue analyses. The study requires compliance with contraception guidelines and includes follow-up for treatment effects and safety throughout the treatment period.

Researchers are evaluating the efficacy and safety of a new antibody-coupled drug called TQB2102 for injection in patients with unresectable locally advanced, recurrent, or metastatic HER2-positive gastroesophageal adenocarcinoma. This Phase II study focuses on how TQB2102 works in combination with Benmelstobart Injection or Penpulimab Injection, with or without chemotherapy, to target HER2 proteins on tumor cells and potentially improve treatment outcomes. The study aims to assess the Objective Response Rate (ORR) over about one year of participation. The treatments being studied include TQB2102 combined with Benmelstobart and chemotherapy or TQB2102 combined with Penpulimab and chemotherapy. TQB2102 is designed to bind more effectively to tumor cell HER2 proteins, while Benmelstobart and Penpulimab are antibodies that may help the immune system target cancer cells. Different dosing regimens of TQB2102 (6 mg or 7.5 mg) are being evaluated, and chemotherapy may be included depending on the treatment group. Participants will be monitored through regular evaluations during the study, which lasts approximately one year. Researchers will measure tumor response and safety outcomes, including lab tests and imaging to confirm measurable lesions according to RECIST 1.1 criteria. The study also involves reviewing previous PD-L1 expression test results or collecting tumor tissue for testing. Safety is closely observed, and participants must meet specific health criteria to join and continue in the trial.

Researchers are evaluating the effectiveness and safety of TQB6411 for Injection in adults with advanced lung cancer. This clinical trial is designed as a Phase Ib/II study to determine the recommended Phase II dosage and to observe the objective response rate over a period of up to six months. Participants must have confirmed lung cancer with measurable lesions and meet specific health and laboratory criteria to be eligible. The treatment involves administering TQB6411 for Injection every 21 days as a cycle. The study focuses on monitoring the drug’s safety and how well it works in treating advanced lung cancer. Participants will receive this treatment while being closely observed for any side effects or responses to the therapy. During the study, participants will undergo various assessments including laboratory tests, tumor tissue sampling for immunohistochemical testing, and regular health evaluations. The main outcomes measured are the recommended dosage for Phase II and the cancer's response to treatment over six months. Participants will be monitored for safety and treatment effects throughout the study period, which includes initial treatment and follow-up assessments.

Researchers are conducting a Phase 1/2a trial to assess the safety and tolerability of DB-1303/BNT323 in people with advanced solid tumors that express HER2. The study focuses on patients with HER2-positive or HER2-expressing malignant solid tumors that are advanced, unresectable, recurrent, or metastatic, and have not responded to standard treatments or have no available standard treatments. This multicenter, open-label study includes an initial dose-escalation phase followed by a dose expansion phase to explore safety, tolerability, and preliminary efficacy of the treatment.

Researchers are conducting a phase I/II clinical trial to study LBL-024 in patients with advanced malignant tumors. This trial aims to assess the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary effectiveness of LBL-024 in patients who have failed standard treatments or for whom no standard treatment is available or applicable. The study includes different phases to explore dose escalation, safety, and efficacy, with a focus on patients with advanced solid tumors. The treatment involves administering LBL-024 by injection every three weeks. The trial is divided into two parts: Part I includes a phase I/IIa dose escalation and pharmacokinetic expansion to evaluate safety and initial efficacy, while Part II is a phase IIb single-arm pivotal study to further assess the treatment in this patient population. Participants will be monitored through various assessments including safety evaluations, pharmacokinetic testing, and measuring tumor response. Key outcomes include determining the maximum tolerated dose, dose-limiting toxicities within three weeks of the first dose, and the objective response rate. Follow-up visits occur 30 days after treatment discontinuation or withdrawal to evaluate ongoing safety and treatment effects. The study requires participants to be adults aged 18 to 80 years with adequate organ function and an expected survival of at least 12 weeks.

Researchers are investigating a phase Ib/II clinical trial of ATG-022 combined with pembrolizumab, with or without chemotherapy, in participants with Claudin (CLDN) 18.2-positive, HER2-negative, PD-L1 positive, unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma. The study includes participants who have either progressed after prior systemic therapy or who have not received prior systemic therapy. The trial aims to evaluate the safety, dosing, and efficacy of these treatment combinations within this specific patient population. The study involves two main treatment groups: one receiving ATG-022 plus pembrolizumab (A+P), and the other receiving ATG-022 plus pembrolizumab combined with chemotherapy using the CAPOX regimen (A+P+C). ATG-022 is administered at 1.8 mg/kg every 21 days, pembrolizumab at 20 mg every 21 days, and CAPOX chemotherapy includes capecitabine and oxaliplatin given every 21 days for eight cycles. The trial starts with the A+P treatment phase, and based on its clinical data, the A+P+C treatment phase may then be initiated. Participants will undergo tumor tissue testing for CLDN 18.2 and PD-L1 expression before enrollment and must have at least one measurable lesion. Researchers will monitor adverse events and serious adverse events up to 12 months after the last participant is enrolled, dose-limiting toxicities within 21 days, and determine the recommended phase 2 dose. The study includes assessments of safety, treatment response, and tolerability throughout the treatment and follow-up periods.