Yanbian Korean Autonomous Prefecture

Researchers are conducting a multicenter, randomized, double-blind, parallel-controlled phase I clinical study to compare HLX17 and US-sourced Keytruda in patients with resected non-small cell lung cancer, melanoma, or renal cell carcinoma. The study aims to evaluate how similar the pharmacokinetic profiles, efficacy, safety, and immune responses are between these two treatments in this patient population. Participants will receive either HLX17 or US-sourced Keytruda. Those in the HLX17 group will get 200 mg on Day 1 of every 3-week cycle for up to 12 months or until disease recurrence, death, new anti-tumor therapy, unacceptable toxicity, consent withdrawal, or study end. The Keytruda group will receive 200 mg every 3 weeks for 8 cycles 24 weeks, then switch to HLX17 on the same schedule until 12 months or similar conditions occur. During the study, participants will undergo various assessments including pharmacokinetic measurements such as drug concentration over time and at steady state, disease-free survival evaluation for up to 12 months, and monitoring for adverse events and laboratory abnormalities for up to 15 months. Safety follow-up includes vital signs, physical exams, ECGs, and immunogenicity evaluation. The total study duration includes treatment and safety monitoring phases.

Researchers are conducting a multicenter, nonrandomized, open-label Phase III clinical trial to evaluate the safety, tolerability, and pharmacokinetics of ICP-723 in patients with solid tumors. The study focuses on patients with surgically unresectable locally advanced or metastatic solid tumors, including primary central nervous system tumors. This trial aims to better understand how ICP-723 behaves in the body and its safety profile during treatment. Participants will receive ICP-723, a white, round, uncoated tablet, as the investigational drug. The study includes adolescent participants aged 12 to under 18 years and adults aged 18 years and older. The trial involves monitoring treatment-emergent adverse events for up to 12 months and determining the maximum tolerated dose within the first two months. Secondary measures include peak drug concentration and objective response rate within specified time frames. During the study, participants will undergo evaluations of safety and tolerability, including assessments of adverse events and pharmacokinetic measurements. Measurable tumor lesions will be monitored according to established criteria. Patients will need to agree to use effective birth control methods if of childbearing potential and comply with visit schedules and treatment regimens. The total participation period includes follow-up for safety and treatment response, with data collected up to 12 months.

Researchers are evaluating HLX22 combined with trastuzumab and chemotherapy as a first-line treatment for patients with HER2-positive locally advanced or metastatic adenocarcinoma of the gastric or gastroesophageal junction. This phase 3, randomized, double-blind study compares this combination against trastuzumab plus chemotherapy with or without pembrolizumab. The trial aims to assess the efficacy and safety of adding HLX22 in this patient population. Participants will be randomly assigned in a 11 ratio to either the experimental group receiving HLX22 15 mgkg plus trastuzumab and chemotherapy XELOX with or without a placebo for pembrolizumab every three weeks, or the control group receiving placebo for HLX22 plus trastuzumab and chemotherapy XELOX with or without pembrolizumab also every three weeks. Treatment continues until clinical benefit is lost, intolerable side effects occur, death, withdrawal, or other protocol-specified reasons. Throughout the study, participants will have their disease progression monitored by an independent radiology review committee using RECIST v1.1 criteria for up to five years, along with overall survival and response rates. Safety will be regularly assessed by tracking adverse events. The study includes multiple assessments to evaluate treatment effects, and participants will be followed for long-term outcomes during the trial period.

Researchers are conducting a Phase III, international, multicenter, randomized, controlled, open-label clinical trial to compare treatments for patients with non-squamous non-small cell lung cancer NSCLC who have brain metastases and specific EGFR mutations. The study aims to evaluate how well furmonertinib combined with platinum-based chemotherapy works compared to osimertinib alone, as well as to explore the effects of furmonertinib alone in some patients. This research focuses on treatments for this type of lung cancer with brain involvement, with safety and effectiveness as key concerns. The trial includes two main stages Stage 1 is a safety run-in phase enrolling about 30 subjects to test different doses of furmonertinib with platinum-based chemotherapy. Stage 2 is the randomized controlled phase, where approximately 350 subjects will be assigned to one of three groups furmonertinib plus platinum-based chemotherapy, osimertinib alone, or furmonertinib alone. Furmonertinib is taken orally daily in varying doses, while chemotherapy drugs like carboplatin, cisplatin, and pemetrexed are given by intravenous infusion every three weeks in cycles. Osimertinib is also taken orally daily. Treatment continues until unacceptable side effects, disease progression, death, or new anti-cancer therapy is started. Participants will undergo safety monitoring for adverse and serious adverse events for up to four years. Researchers will assess progression-free survival, response rates, disease control, overall survival, and patient-reported outcomes using questionnaires. Blood samples and other lab tests will measure drug levels and effects. The study also tracks tumor response using imaging and other evaluations. Participants are expected to attend regular visits for treatment, monitoring, and assessments throughout the study duration.

Researchers are studying BL-M07D1, an intravenous drug, to evaluate its safety, tolerability, and preliminary effectiveness in patients with locally advanced or metastatic HER2-positive or low-expression breast cancer and other solid tumors. This phase I trial aims to identify the dose-limiting toxicity, maximum tolerated dose, and the recommended dose for future studies. The study includes patients who have failed or are not eligible for standard therapies. Participants receive BL-M07D1 through intravenous infusion every three weeks during the first treatment cycle. Those who show clinical benefit may continue receiving additional cycles until disease progression, intolerable side effects, or other reasons cause treatment to stop. The study proceeds through phase Ia to phase Ib to determine safe dosing and monitor the drugs pharmacokinetics and immunogenicity. During the trial, participants will undergo assessments including tumor tissue analysis, imaging to measure lesions, and health evaluations such as heart function and blood tests. Researchers will track side effects, immune response to the drug, and tumor response over approximately 24 months. The primary outcomes focus on safety and dose recommendations within 21 days after the first dose, while secondary outcomes include longer-term measures like disease control, response duration, and progression-free survival.

Researchers are evaluating HLX42, an investigational 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 and tolerability of HLX42, focusing on dose-limiting toxicities and maximum tolerated dose. The study includes patients whose tumors are resistant or intolerant to standard treatments or for whom no standard therapy exists. The trial has two stages initially, a dose escalation phase using a 33 design where patients receive escalating doses of HLX42 via intravenous infusion and are monitored for toxicities during the first 3 weeks. In the second stage, about 60 patients are randomized into two groups receiving fixed doses of HLX42 at 2.5 mgkg or 2.0 mgkg every three weeks. Treatment continues until disease progression, intolerable side effects, or patient withdrawal. Participants will undergo regular assessments including tumor measurements by RECIST 1.1 criteria, laboratory tests, and evaluations of organ function. Safety is closely monitored through adverse event recording up to 90 days after the last dose. The study will also evaluate pharmacokinetic characteristics and anti-drug antibodies over approximately 24 months, with survival outcomes tracked during this period. Treatment tolerability and clinical benefit guide ongoing therapy decisions throughout the trial.

Researchers are studying the effectiveness and safety of lebrikizumab in people aged 12 and older who have chronic rhinosinusitis with nasal polyps and are treated with intranasal corticosteroids. This Phase 3 trial compares different dosing schedules of lebrikizumab with a placebo to find out how well it reduces symptoms such as nasal congestion and polyp size over about 18 months. Participants receive lebrikizumab or placebo as subcutaneous injections while continuing their regular intranasal corticosteroid therapy. Adolescents aged 12 to under 18 weighing at least 40 kg will receive open-label lebrikizumab every 2 or 4 weeks. The study includes two experimental lebrikizumab groups with different dosing intervals and a placebo group, all alongside background intranasal corticosteroids. During the study, participants will have regular assessments including symptom severity scores, nasal polyp size measured by endoscopy, sinus imaging, lung function tests, and questionnaires about nasal symptoms and quality of life. Researchers will monitor changes from baseline to week 24 primarily for nasal congestion and polyp scores. Safety and long-term effects will also be observed throughout the study duration of about 18 months.

Researchers are evaluating the safety and effectiveness of olverembatinib combined with chemotherapy compared to an investigators choice of tyrosine kinase inhibitor TKI combined with chemotherapy in adults newly diagnosed with Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia Ph ALL. This global, randomized, open-label Phase 3 study aims to provide important information about treatment options for this specific type of leukemia. Participants will receive either olverembatinib taken orally every other day along with chemotherapy, or a TKI chosen by the investigator taken orally once daily with chemotherapy. The study includes two groups one receiving the experimental olverembatinib combination and the other receiving the control treatment with investigator-selected TKI. Treatment cycles last 28 days, and the study follows participants through multiple cycles. During the study, participants will be monitored for their response to treatment by checking minimal residual disease negative complete remission rates during the first three cycles. Researchers will also assess event-free survival for up to 3 to 6 years, treatment-related side effects, drug levels in the blood, and quality of life related to leukemia. Safety assessments and other evaluations will continue through approximately two years of study participation, allowing for long-term monitoring of treatment effects and participant health.

This research aims to evaluate the long-term safety of pirtobrutinib in people who have previously been treated for chronic lymphocytic leukemia CLL or small lymphocytic lymphoma SLL. It offers continued access to the study drug or follow-up for participants who completed a prior related study LOXO-BTK-20020. The study is designed to observe and monitor safety outcomes over an extended period. Participants receive either pirtobrutinib or idelalisib orally as part of the study treatments. These medications are taken every four weeks. The study is expected to last about five years, allowing researchers to collect long-term safety data on these treatments in a parallel group setup. Throughout the study, participants will have regular visits to monitor their health and any treatment-related effects. Researchers will track the percentage of participants experiencing serious treatment-emergent adverse events. They will also observe overall survival from the original study enrollment. Safety monitoring will continue up to 30 days after the last dose or until new anticancer therapy begins, ensuring careful follow-up for each participant.

Researchers are studying XS-04 tablets in patients with relapsed or refractory blood cancers, including B-cell lymphoma, acute myeloid leukemia, and myelodysplastic syndrome. The main goal is to evaluate the safety and tolerability of XS-04, determine the highest dose patients can handle, and find the recommended dose for future studies. The trial also looks at how the body processes the drug and explores early signs of how well the treatment works, including how food affects drug levels and the relationship between drug exposure and biological markers. This is a Phase I, open-label study with a dose escalation phase and a dose expansion phase. In the dose escalation phase, patients receive increasing doses of XS-04 tablets orally twice daily in 28-day cycles, starting with a smaller initial dose to observe drug behavior. Dose levels range from 1 mg up to 160 mg per day, with adjustments allowed based on safety and drug levels. Following this, selected doses will be studied further in the dose expansion phase with specific patient groups. Treatment is continuous throughout each cycle. Participants will attend visits for safety monitoring, laboratory tests, and assessments throughout the study. Researchers will track adverse events, measure drug levels in blood after single and multiple doses, and evaluate treatment impact through biomarker analysis. Bone marrow samples and imaging will be used to assess disease status. Participants will be followed for up to 24 months to monitor side effects and determine the maximum tolerated dose and recommended Phase II dose. The study ensures careful monitoring of health and treatment effects during and after the trial.