Xinxiang

Researchers are evaluating the preliminary anti-tumor effects and safety of Hemay181 in adults with advanced solid tumors who have not responded to standard treatments or have no effective standard therapy available. This open-label Phase I clinical study focuses on patients with measurable lesions that can be assessed using CT or MRI scans. The study aims to measure how well Hemay181 works by monitoring the time until tumor progression or death. Participants receive Hemay181 as an intravenous infusion once every three weeks during each treatment cycle. The study does not include a placebo group and is designed to observe the effects and safety of this drug over time. The treatment period continues until the patient experiences disease progression or death, with assessments lasting up to 100 months. During the study, participants will have regular evaluations including imaging scans to track tumor size and laboratory tests to monitor safety. Researchers will follow patients closely from the start of treatment until progression or death, with a focus on both efficacy and safety indicators. The total duration of participation varies depending on individual response and disease progression.

Researchers are evaluating the effectiveness and safety of TQB2102 for injection compared to a standard chemotherapy regimen called TCbHP in patients with HER2-positive breast cancer. This phase III, randomized, open-label, multi-center study focuses on neoadjuvant treatment, which is therapy given before surgery. The study aims to measure the total pathological complete response and other outcomes such as event-free survival and overall survival. Participants receive either TQB2102 for injection at 6 mgkg by intravenous infusion every 3 weeks for 8 cycles or a combination of Trastuzumab, Pertuzumab, Docetaxel, and Carboplatin given intravenously every 3 weeks for 6 cycles. The study monitors participants throughout the treatment period and collects data on tumor response and side effects. During the study, participants will undergo assessments including tumor response evaluations by independent review and investigators, safety monitoring for adverse events, and laboratory tests. Follow-up will continue for up to 50 months after the start of the study to observe long-term outcomes. Participants are expected to comply with contraceptive use requirements and attend all scheduled visits for treatment and evaluations.

Researchers are investigating a combination therapy of BNT326 and pumitamig also called BNT327 or PM8002 in adults with advanced or metastatic non-small cell lung cancer NSCLC who may have relapsed, progressive, or treatment-nafve disease. This multi-site, open-label study aims to find the best dose levels for this combination, assess how well participants tolerate the therapy, including side effects, and evaluate its ability to shrink tumors in this population. The study has three parts Part 1 focuses on finding safe dose levels for the combination Part 2a expands the dose evaluation to assess preliminary effectiveness and safety Part 2b is a randomized phase to optimize doses and understand the contribution of each drug component. Participants will receive intravenous infusions of BNT326 and pumitamig or pumitamig alone in some arms. Treatment continues until disease progression, unacceptable side effects, withdrawal, study end, or up to 24 months. Dose levels for later parts are chosen based on earlier safety and efficacy data. Participants will go through screening, treatment, safety follow-up, efficacy follow-up, and long-term survival follow-up phases, with total involvement expected to last about 36 months unless treatment benefit continues. Assessments include monitoring for dose-limiting toxicities, adverse events, tumor response, progression-free survival, overall survival, and pharmacokinetics of the drugs. Safety evaluations continue up to 90 days after treatment ends, and antibody responses to the drugs are also measured for up to one year post-treatment.

Researchers are evaluating BG-C137, an antibody-drug conjugate targeting FGFR2b, in people with advanced solid tumors. This study aims to assess the safety, tolerability, how the drug moves and acts in the body, and early antitumor effects. It is a phase 1ab trial involving participants with tumors expressing FGFR2b or FGFR2 gene amplification who have received prior cancer treatments. The study is sponsored by BeOne Medicines and includes two main phases dose escalation and dose expansion. The trial has three parts Phase 1a evaluates increasing doses of BG-C137 alone and then in combination with other anticancer agents to establish safe dose levels. Phase 1b further explores the recommended dose in selected patient groups. BG-C137 and anticancer agents are given intravenously or orally depending on the treatment. Participants undergo dose escalation, safety expansions, and dose confirmations to determine the best dosing for further study. Participants will be monitored regularly for side effects and response to treatment for up to about two years. Assessments include measuring adverse events, drug levels in the blood, tumor response, and immune reactions to the drug. Safety follow-up visits occur after treatment ends. Researchers will measure outcomes such as maximum tolerated dose, overall response rate, disease control, and progression-free survival. The trial involves frequent visits for treatment and assessments throughout the study period.

Researchers are evaluating the safety, tolerability, and effectiveness of a drug called RC278 for treating locally advanced unresectable or metastatic malignant solid tumors. The study aims to find the highest safe dose, the recommended dose for further testing, and to assess how well RC278 works at that dose. This trial is a combined Phase III clinical study sponsored by RemeGen Co., Ltd., focusing on patients with solid tumors who meet specific health criteria. The study includes several stages starting with five groups receiving increasing doses of RC278 to identify the maximum tolerated dose or maximum administered dose. Following this dose-escalation, selected doses will be further tested in a randomized manner to determine the recommended Phase II dose. In the expansion phase, this dose will be studied in different types of cancers to further evaluate safety and effectiveness. RC278 is given intravenously every three weeks, and treatment continues until unacceptable side effects occur, the disease progresses, or the participant withdraws. Participants will be monitored for up to 24 months to track dose-limiting toxicities, adverse events, and tumor response using standard criteria. Assessments include imaging to measure tumor size, safety evaluations, and pharmacokinetic testing. The study collects data on how well participants tolerate the drug and how their tumors respond. Follow-up continues throughout the study to ensure participant safety and to gather comprehensive information on the drugs effects.

Researchers are studying DB-1311BNT324 in adults with advanced solid tumors that have progressed after standard treatments or have no standard options available. This Phase 12a trial aims to evaluate the safety, tolerability, and early effectiveness of DB-1311BNT324, including its use alone or combined with new hormone therapies in prostate cancer. The study also investigates drug interactions with lopinavirritonavir and itraconazole. Participants receive intravenous doses of DB-1311BNT324 every three weeks at different dose levels to identify the best tolerated dose and recommended dose for further study. The trial includes various groups with specific tumor types, such as small cell lung cancer, non-small cell lung cancer, esophageal cancer, prostate cancer, melanoma, liver cancer, cervical cancer, ovarian cancer, head and neck cancer, and rare tumors. Some groups receive DB-1311BNT324 alone, while others receive it combined with oral hormone therapies or other drugs. During the study, participants undergo regular safety checks including vital signs, blood tests, heart function tests, and cancer status assessments. Researchers monitor side effects, serious adverse events, and tumor responses up to about one year after treatment. The main goal is to find the maximum tolerated dose and assess the drugs safety and preliminary antitumor activity. Participants health and cancer are closely followed throughout and after treatment.

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 evaluating FWD1802, a drug being studied for patients with estrogen receptor-positive ER, human epidermal growth factor receptor 2-negative HER2- advanced breast cancer that cannot be removed by surgery or has spread to other parts of the body. This phase III study aims to find the best dose of FWD1802 and assess its safety, tolerability, and effect on tumors, especially in patients whose cancer has specific ESR1 mutations. The study is multicenter, open-label, and includes patients with locally advanced or metastatic breast cancer. The study has three parts Phase I Part A is a dose-escalation phase where up to 27 patients receive increasing doses of FWD1802 tablets, starting with a single dose followed by daily dosing in 28-day cycles. Phase I Part B is a dose-expansion phase exploring 2 to 4 selected dose levels in up to 10 patients per dose to study pharmacokinetics and confirm the recommended dose for Phase II. Phase II focuses on up to 60 patients with ESR1 mutations receiving one or two dose levels to evaluate FWD1802s anti-tumor efficacy and safety. Treatment may continue up to two years or longer if beneficial and agreed upon. Participants will undergo screening including mutation testing and must meet health criteria to join. During treatment, they will receive FWD1802 daily and have blood tests to monitor mutations and drug effects. The study measures safety, drug levels in the body, tumor response, and patient outcomes over about two years. Follow-up includes monitoring for side effects, response to treatment, and disease progression. The trial is designed to gather detailed information about FWD1802s use in this breast cancer type and mutation status.

Researchers are evaluating a phase IbII study of ATG-022 plus pembrolizumab with or without chemotherapy in participants who have Claudin 18.2-positive, HER2-negative, PD-L1 positive advanced or metastatic gastric or gastroesophageal junction adenocarcinoma. The study targets adults who have either progressed after prior systemic therapy or who have not received any systemic therapy for their condition. The study aims to assess the combination treatments for this specific cancer type. Participants receive either ATG-022 plus pembrolizumab alone or combined with chemotherapy CAPOX regimen, including capecitabine and oxaliplatin. The ATG-022 and pembrolizumab drugs are given every 21 days as one cycle, while the CAPOX chemotherapy is administered in 3-week cycles for up to 8 cycles. The study begins with the evaluation of ATG-022 plus pembrolizumab alone, and the addition of chemotherapy will start based on clinical data from this initial group. Throughout the study, participants undergo tumor testing, imaging, and clinical evaluations to measure safety and effectiveness. Researchers monitor adverse events, dose-limiting toxicities, and treatment responses for up to 12 months after enrollment. Blood samples are collected to analyze drug concentrations. Participants are closely followed to assess overall response, duration of response, and progression-free survival, ensuring comprehensive safety and treatment effect data collection.

Researchers are evaluating the safety, effectiveness, and how the body processes INT-210 capsules in adults with active ulcerative colitis UC. This randomized, open-label study focuses on participants aged 18 to 75 years diagnosed with active UC, aiming to gather detailed information on the drugs pharmacokinetics and pharmacodynamics while monitoring treatment safety. Participants will receive oral INT-210 capsules in one of two doses 200 mg twice daily or 400 mg twice daily, starting from Day 1 of a 12-week treatment period. The study is designed to compare these two dosing regimens in parallel groups to assess their impact on UC symptoms and drug behavior in the body. During the study, participants will undergo various assessments including laboratory tests to monitor safety, clinical evaluations to measure remission and response rates, and pharmacokinetic sampling up to Day 85. Safety follow-up continues through Day 92 to track adverse events and important clinical parameters. Overall, participants can expect regular visits and monitoring throughout the treatment and follow-up phases lasting approximately 3 months.