Ji An

Researchers are evaluating the effectiveness and safety of IN10018 combined with D-1553 compared to a standard first-line treatment involving an anti-PD-1 monoclonal antibody combined with platinum and pemetrexed chemotherapy. This Phase III, multicenter, randomized, open-label study focuses on patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) that has the KRAS G12C mutation. The study builds on earlier Phase Ib/II results showing promising antitumor activity and tolerability of the drug combination in KRAS G12C-mutant solid tumors, including NSCLC and metastatic colorectal cancer. Participants will receive either IN10018 at 100 mg once daily by mouth plus D-1553 at 600 mg twice daily by mouth in 21-day cycles, or the standard therapy of tislelizumab 200 mg intravenously every 3 weeks combined with either carboplatin or cisplatin plus pemetrexed every 3 weeks intravenously. The study compares these two treatments as first-line options for advanced KRAS G12C-mutant NSCLC. During the study, participants will be closely monitored up to 36 months to assess progression-free survival. Evaluations include clinical assessments, tumor measurements following RECIST criteria, and safety monitoring. Participants must comply with study requirements and use effective contraception if of reproductive potential. The overall goal is to determine if the new combination therapy offers improved outcomes compared to standard treatment over the study period.

This trial studies patients with limited stage small cell lung cancer who have not shown disease progression after concurrent chemoradiation therapy. It is a randomized, double-blind, phase III clinical study designed to compare the effectiveness and safety of the drug AK112 against a placebo as a consolidation treatment. The goal is to evaluate the potential benefits of AK112 in improving outcomes for these patients. Participants receive either AK112 at a dose of 20 mg/kg or a placebo, both administered intravenously every three weeks (Q3W). The treatment is given as consolidation therapy following initial chemoradiation, aiming to maintain disease control. The study involves two groups: one receiving AK112 and the other receiving placebo, with both treatments delivered under double-blind conditions. Throughout the trial, researchers monitor participants for up to approximately six years, focusing on progression-free survival and overall survival as primary outcomes. Patients undergo regular assessments to track disease status and safety, including blinded independent center reviews. The long-term follow-up ensures comprehensive evaluation of treatment effects and participant safety over time.

Researchers are evaluating HCB301, an engineered fusion protein given by intravenous injection, as a potential treatment for adults aged 18 years and older with advanced solid tumors or relapsed and refractory classical Hodgkin lymphomas. This phase 1, open-label, multicenter, dose-escalation study aims to assess the safety, tolerability, pharmacokinetics, preliminary effectiveness, and to find the maximum tolerated dose (MTD) of HCB301. Participants included must have failed standard treatments or be considered unsuitable for them by their doctors. Participants will receive HCB301 through intravenous infusion. Treatment continues until unacceptable side effects, disease progression confirmed by scans or clinical evaluation, withdrawal of consent, loss to follow-up, death, or study end, whichever happens first. There is no comparator group mentioned, and dose escalation will help identify the safest and most effective dose range. During the study, researchers will monitor participants for side effects, including the presence of anti-drug antibodies, and track the number of participants reaching the maximum tolerated dose and recommended dose for expansion over 12 months. Regular assessments include tumor tissue sampling, clinical evaluations, and performance status checks. The study also evaluates safety and tolerability throughout the treatment period, with follow-up for adverse events and disease status.

Researchers are evaluating the effectiveness and safety of TQC2731 injection, a humanized monoclonal antibody that targets Thymic Stromal Lymphopoietin (TSLP) to block its pathway and reduce inflammation. The study focuses on adults aged 18 to 75 years with chronic rhinosinusitis and nasal polyps (CRSwNP), a condition involving persistent nasal symptoms and polyps in both nostrils. This is a Phase III clinical trial designed to assess improvements in nasal polyp size and nasal congestion over 24 weeks. Participants will be randomly assigned to receive either TQC2731 injection or a placebo. The study involves monitoring the nasal polyp score (NPS) and nasal congestion score (NCS) from baseline through 24 weeks to evaluate changes. Both groups will continue using a stable dose of intranasal corticosteroids during the study. The trial is double-blind and placebo-controlled, ensuring that neither participants nor researchers know which treatment is given. During the study, participants will undergo nasal endoscopy to assess polyp size and daily or weekly symptom scoring for nasal congestion. Researchers will track adherence to nasal spray use and symptom recording through electronic diaries. Safety will be monitored throughout, and participants will be followed for 24 weeks to measure changes in nasal polyp and congestion scores as primary outcome measures.

Researchers are investigating a high-risk form of locally advanced nasopharyngeal carcinoma characterized by N3 classification, rENE positivity, and detectable Epstein-Barr virus (EBV) DNA after induction chemotherapy. This phase III clinical trial aims to determine if maintenance therapy combining toripalimab with capecitabine is more effective than capecitabine alone in reducing the risk of disease progression in these high-risk patients. Participants are randomly assigned to one of two groups: one receiving maintenance therapy with both toripalimab and capecitabine, and the other receiving capecitabine alone. Capecitabine is taken orally at 1000 mg/m2 twice daily on days 1 to 14 every three weeks, and toripalimab is administered intravenously at 240 mg every three weeks. The total duration of maintenance therapy for both groups is one year. During the study, participants will undergo regular assessments to monitor their health and response to treatment. Researchers will measure progression-free survival over three years as the main outcome. Safety and organ function will also be evaluated, with careful monitoring for any side effects or complications. The study involves multiple centers and includes patients aged 18 to 70 years who have completed prior chemotherapy and chemoradiotherapy.

Researchers are evaluating PM8002, a bispecific antibody that targets PD-L1 and VEGF-A, as a single treatment in adults with advanced solid tumors. This Phase Ib/IIa study aims to understand the safety, tolerability, how the drug moves and acts in the body, immune response, and anti-tumor effects of PM8002 in this patient group. The study focuses on patients with malignant tumors confirmed by tissue analysis who have not fully recovered from previous anti-tumor treatments. Participants will receive PM8002 through intravenous infusion. The study does not mention comparator groups, focusing on the effects of this single agent. Treatment monitoring includes evaluating dose-limiting toxicities during the first three weeks of therapy. The treatment period is followed by safety monitoring for adverse events up to 30 days after the last dose. Participants will be observed for objective tumor response for up to approximately two years. Throughout the study, participants will undergo various assessments including safety evaluations, pharmacokinetic and pharmacodynamic tests, and immunogenicity measurements. Researchers will track adverse events and tumor responses based on RECIST 1.1 criteria, requiring at least one measurable lesion. Participants must have an ECOG performance status of 0-1 and an expected survival of at least 12 weeks. The overall study duration includes treatment and long-term follow-up to evaluate the drug's safety and effectiveness.