Yanbian Korean Autonomous Prefecture

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 clinical trial is studying adults and adolescents with advanced solid tumors or primary central nervous system tumors that cannot be removed by surgery or have spread to other parts of the body. The study aims to evaluate the safety, tolerability, and how the body processes ICP-723, a drug being tested for these tumors. The trial is a phase I/II, open-label study conducted at multiple centers to gather detailed information about the effects of ICP-723 in these patients. Participants will receive ICP-723, an uncoated white, round tablet, as the investigational treatment. The study includes both adult and adolescent groups, with dosing and treatment monitored for safety and tolerability. The trial will assess the maximum tolerated dose within the first 2 months and continue to monitor for treatment-emergent adverse events throughout a 12-month period. Throughout the study, participants will undergo regular evaluations including physical exams, performance status assessments, and tumor measurements using standard criteria. Researchers will closely monitor safety by tracking adverse events and pharmacokinetic data. Participants are expected to follow the treatment and visit schedule, with safety and treatment effects observed for up to one year after starting ICP-723.

Researchers are evaluating the safety and effectiveness of HLX22 combined with trastuzumab and chemotherapy as the first treatment for patients with HER2-positive locally advanced or metastatic adenocarcinoma of the gastric or gastroesophageal junction. This phase 2, double-blind, randomized, and multiregional study compares this combination against trastuzumab and chemotherapy with or without pembrolizumab. The study aims to measure how well the treatments work in controlling the disease and improving survival for up to five years. Participants will be randomly assigned to one of two groups. One group receives HLX22 at 15 mg/kg every three weeks along with trastuzumab, chemotherapy (XELOX regimen), and possibly a placebo for pembrolizumab. The other group receives a placebo for HLX22 plus trastuzumab, chemotherapy (XELOX), and possibly pembrolizumab every three weeks. Treatment continues until the disease worsens, unacceptable side effects occur, withdrawal of consent, or other protocol-specified reasons. Throughout the study, participants will undergo regular assessments including tumor scans reviewed by an independent committee to evaluate progression-free survival and overall survival over up to five years. Other evaluations include safety monitoring and organ function tests. The study tracks how long patients live without disease progression and overall survival, aiming to better understand the benefits and risks of HLX22 combined with current standard treatments.

Researchers are investigating treatments for patients with non-squamous non-small cell lung cancer (NSCLC) that has spread to the brain and who have specific mutations in the EGFR gene. This Phase III, international, multicenter, randomized, controlled, open-label clinical trial aims to compare the effectiveness and safety of furmonertinib combined with platinum-based doublet chemotherapy versus osimertinib alone. A smaller group will receive furmonertinib alone to further understand its safety and effectiveness. The study has two stages. Stage 1 is a safety run-in phase enrolling about 30 participants to test two doses of furmonertinib (80 mg or 160 mg daily) combined with platinum chemotherapy. Stage 2 is the randomized controlled phase with approximately 350 participants assigned in a 3:3:1 ratio to receive either furmonertinib plus chemotherapy, osimertinib alone, or furmonertinib alone. Chemotherapy cycles last 21 days, with drugs administered intravenously including carboplatin or cisplatin and pemetrexed, while furmonertinib and osimertinib are taken orally daily. Participants will be monitored for up to 4 years, assessing adverse events, serious adverse events, and progression-free survival. Assessments include regular clinical evaluations, laboratory tests, and imaging to track disease progression and treatment safety. The study also involves close safety monitoring and follows participants until intolerable toxicity, disease progression, death, or new anti-tumor therapy initiation.

Researchers are evaluating the safety, tolerability, pharmacokinetic properties, and preliminary effectiveness of BL-M07D1 in patients with locally advanced or metastatic HER2-positive or low-expression breast cancer and other solid tumors. This Phase I clinical study aims to determine the dose-limiting toxicity, maximum tolerated dose, and recommended dose for Phase II studies of BL-M07D1. The trial focuses on patients whose tumors have failed standard therapy or are not eligible for it, including those with specific HER2 expression levels confirmed by pathology. Participants will receive BL-M07D1 administered through intravenous infusion. The study includes two parts: Phase Ia, where the safety and tolerability are assessed to find the maximum tolerated dose, and Phase Ib, which further evaluates safety at the recommended dose from Phase Ia and establishes the recommended Phase II dose. Both phases monitor dosing and patient responses within 21 days after the first dose. During the study, patients will undergo various assessments including tumor tissue analysis, physical exams, and monitoring of organ function and adverse effects. Researchers will track safety measures like dose-limiting toxicity and maximum tolerated dose, as well as pharmacokinetic and immunogenicity profiles. The study requires participants to have measurable tumors and good performance status, with ongoing monitoring to evaluate treatment effects and safety throughout the trial period.

Researchers are evaluating HLX42, an anti-EGFR antibody drug conjugate, in patients with advanced or metastatic solid tumors, including non-small cell lung cancer (NSCLC). This open-label, first-in-human Phase I study aims to assess the safety, tolerability, and pharmacokinetics of HLX42. The study includes two stages: an initial dose escalation phase and a randomized phase comparing two dosing levels of HLX42. In the first stage, patients receive increasing doses of HLX42 through intravenous infusion using a 3 + 3 dose escalation method, with a 3-week dose-limiting toxicity (DLT) observation period. The second stage randomizes about 60 patients into two groups receiving either 2.5 mg/kg or 2.0 mg/kg of HLX42, considering tumor type and EGFR mutation status. Treatment cycles last 3 weeks, and patients are monitored closely throughout. Participants undergo various assessments including safety evaluations, laboratory tests, and pharmacokinetic measurements during and after treatment cycles. The primary outcomes measured are the dose-limiting toxicity within 21 days after the first dose and the maximum tolerated dose of HLX42. The study includes patients aged 18 to 75 years, with ongoing monitoring to evaluate the drug's effects and safety profile.

Researchers are evaluating the safety and effectiveness of lebrikizumab in people aged 12 years and older who have chronic rhinosinusitis with nasal polyps and are being treated with intranasal corticosteroids. This Phase 3 study is designed to better understand how lebrikizumab works alongside standard nasal spray treatments over a period of about 18 months. Participants will receive either lebrikizumab or a placebo by subcutaneous injection, while continuing their regular intranasal corticosteroid spray treatment. The study is randomized, double-blind, and placebo-controlled, meaning neither participants nor researchers know who receives the active drug or placebo. The study measures changes from baseline in nasal congestion severity and nasal polyp size using participant reports and endoscopic scoring at the start and after 24 weeks. During the study, participants will undergo evaluations including nasal examinations and symptom assessments at specified times. Researchers will monitor nasal polyp scores and nasal congestion severity to assess treatment impact. Safety and side effects will also be closely observed throughout the study. The total duration of participation is approximately 18 months, allowing careful tracking of treatment outcomes and safety over time.

Researchers are conducting a global Phase 3 study to compare the effectiveness and safety of olverembatinib combined with chemotherapy versus the investigator's choice of tyrosine kinase inhibitor (TKI) combined with chemotherapy in patients newly diagnosed with Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia (Ph+ ALL). This study aims to evaluate these treatments in a randomized and open-label setting to determine the best approach for this condition. Participants will receive treatment in one of two groups: one group will take olverembatinib orally every other day along with chemotherapy, while the other group will receive an investigator-chosen TKI orally once daily combined with chemotherapy. Both treatments are studied over cycles of 28 days, focusing on the initial three cycles for measuring response. During the study, participants will be monitored for treatment effects, including the rate of minimal residual disease negative complete remission from cycles 1 to 3. Researchers will assess safety, treatment adherence, and any side effects. The study includes various evaluations to ensure participant health and treatment effectiveness over the course of therapy.

This research aims to evaluate the long-term safety of pirtobrutinib in adults who have previously been treated for chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). It focuses on participants who completed a prior study (J2N-MC-JZNN/LOXO-BTK-20020) and offers them continued access to the study drug or follow-up visits. The study is in Phase 4 and targets assessing safety outcomes over an extended period. Participants will receive pirtobrutinib orally every four weeks. The study includes treatment administration and ongoing follow-up for about five years, allowing researchers to monitor the long-term effects of the drug. Idelalisib is also listed as an intervention but the study primarily assesses pirtobrutinib. Throughout the study, researchers will monitor participants for any treatment-emergent adverse events of grade 3 or higher from the first dose until 30 days after the last dose or start of new anticancer therapy, whichever occurs first. Participants will be regularly assessed during their visits to ensure safety and collect necessary data over the duration of the study.

Researchers are evaluating the safety, tolerability, pharmacokinetics, and early effectiveness of XS-04 tablets in adults with relapsed or refractory hematologic cancers, including B-cell lymphoma, acute myeloid leukemia, and myelodysplastic syndrome. This phase 1 trial aims to find the highest dose patients can tolerate and the recommended dose for future studies while also exploring how the drug is processed in the body and its relationship with biomarkers and food intake. Participants receive XS-04 tablets taken orally twice a day in continuous 28-day treatment cycles. The study includes a dose escalation phase for patients with mature B-cell malignancies who have exhausted other treatments, and a dose expansion phase for patients with specific types of B-cell lymphoma and myeloid tumors. The study evaluates the drug's effects over up to 24 months, monitoring for dose-limiting toxicities and determining the maximum tolerated dose or recommended phase 2 dose. Participants will undergo regular assessments including physical exams, laboratory tests, bone marrow biopsies, and imaging to measure tumor lesions. Researchers will monitor side effects, drug levels, and biological markers throughout the study. Safety will be checked at the end of each treatment cycle, and participants are expected to comply with study procedures and follow-up visits to help evaluate XS-04's impact and tolerability.