Jinhua

Researchers are studying 89Zr-TLX250, a diagnostic imaging agent, to detect clear cell renal cell carcinoma ccRCC in Chinese patients with indeterminate renal masses. This Phase 3, open-label, single-arm study aims to confirm the safety, tolerability, sensitivity, and specificity of 89Zr-TLX250 PETCT imaging. The study supports prior ZIRCON trial data and involves adult patients scheduled for partial or total nephrectomy as part of their standard care. Participants will receive a single intravenous dose of 37 MBq of 89Zr-TLX250 containing 10 mg of girentuximab. Imaging of the abdomen using PETCT will be performed 5 days post-administration, with possible whole-body imaging if widespread disease is suspected. Nephrectomy will occur any time after imaging but within 90 days. Histological analysis of tumor samples will confirm diagnosis. The study includes approximately seven visits over 4 to 6 months. Assessments include baseline exams, PETCT imaging, surgery, and follow-up visits. Imaging and histological data will be centrally analyzed to evaluate diagnostic accuracy. Safety and tolerability will be monitored throughout. The study is expected to last about 12 months with 4 months of follow-up per participant.

Researchers are evaluating the safety, tolerability, drug levels, and early clinical activity of JAB-21822 in patients with locally advanced or metastatic non-small cell lung cancer NSCLC who have tumors with a KRAS p.G12C mutation and a co-mutation in STK11, while having wild-type KEAP1. This trial includes patients who are either newly diagnosed or have received at least one prior treatment for advanced disease. The study is a Phase IbII, open-label, multi-center trial sponsored by Allist Pharmaceuticals, Inc. The study includes a Dose Escalation phase where JAB-21822 is given as a monotherapy to find the maximum tolerated dose MTD and recommended Phase 2 dose RP2D. After this, there are two Dose Expansion parts Part 1 tests safety and clinical activity in patients who have not been treated before, and Part 2 evaluates the same outcomes in patients who have had at least one previous systemic therapy. JAB-21822 is administered orally throughout the study. Participants will be monitored for dose-limiting toxicities and adverse events during the Dose Escalation phase and safety and clinical responses during the Dose Expansion phases for up to three years. Researchers will assess tumor responses using objective response rates and other measures like progression-free survival and overall survival. Drug plasma levels will also be tracked. This comprehensive monitoring includes regular clinical evaluations and follow-up to understand the drugs effects and safety over time.

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.

Researchers are evaluating the safety and antitumor activity of the drug INV-9956 in adult men with advanced metastatic castration resistant prostate cancer. This study is conducted in two parts Phase 1 focuses on finding the right dose and assessing safety, while Phase 2 aims to confirm safety and explore how well the drug works in patients with different androgen receptor gene statuses. Participants receive INV-9956 along with dexamethasone and fludrocortisone acetate. In Phase 1, dose levels are gradually increased using a careful monitoring process to find the maximum tolerated dose and recommended dose range. Phase 2 includes two groups one with mutated androgen receptor cancer and one with wild-type androgen receptor cancer, to further evaluate the drugs effects. During the study, participants will undergo various assessments including safety evaluations, blood tests for drug concentration and hormone levels, and imaging to track cancer progression. The main outcomes measured are maximum tolerated dose, radiographic progression-free survival, and overall response rate over 12 months. The study also monitors side effects and drug behavior in the body to better understand treatment effects and safety.

Researchers are studying Hydronidone capsules, a new pyridinone-based drug, to understand its safety and how it behaves in the body, especially in patients with kidney problems. Although preliminary studies showed Hydronidone may be safe and effective for liver fibrosis caused by chronic hepatitis B, this trial focuses on how the drug works and is tolerated in people with different levels of kidney function. Participants will take a single 90mg dose of Hydronidone capsules on an empty stomach on the first day. The study includes groups of healthy individuals and patients with mild, moderate, or severe renal insufficiency, defined by their estimated glomerular filtration rate eGFR. Each participant receives the same dose, and the trial compares these groups to assess differences in drug processing. During the study, researchers will collect blood and urine samples over 48 hours to measure drug and metabolite levels. Safety will be monitored through ultrasound exams of various organs and electrocardiograms within 72 hours after dosing. Participants will be observed for any adverse events, and their overall health will be assessed before and after the study period, which runs until July 2026.

Researchers are evaluating the effectiveness and safety of Tegileridine Fumarate Injection for managing prolonged abirritation lasting 48 to 72 hours in patients receiving mechanical ventilation in the intensive care unit ICU. This Phase II, randomized, single-blind study compares different doses of Tegileridine Fumarate Injection with Remifentanil Hydrochloride for Injection as a positive comparator, aiming to better support patients during extended ventilation periods. Participants are randomly assigned to one of three groups low dose Tegileridine Fumarate Injection, high dose Tegileridine Fumarate Injection, or Remifentanil Hydrochloride for Injection. The study explores dose levels and monitors responses over the drug administration period, which lasts up to three days. The trial takes place across multiple centers and includes a single-blind design to assess safety and efficacy. During the study, participants will be closely monitored for their ability to maintain target abirritation, use of rescue analgesic drugs, sedation levels, nursing scores, and the timing of mechanical ventilation and extubation. Outcomes are measured within 72 hours after drug administration. The study involves detailed assessments to understand treatment impact and ensure participant safety, with the total participation period lasting up to three days post-treatment.

Psoriasis is a chronic, recurring inflammatory disease influenced by genetics and environmental factors, marked by skin lesions that can affect multiple organs. Researchers are evaluating the effectiveness of different treatments chosen by patients in real-world clinical settings, comparing phototherapy, traditional systemic therapies, and biologics among Chinese psoriasis patients. This observational study aims to gather real-world evidence under routine care without intervention. Patients diagnosed with psoriasis by dermatologists choose their preferred treatments, which may include phototherapy, traditional systemic drugs, or biologics. The study does not assign treatments but observes outcomes as patients follow their chosen therapies. Data collection is supported through a phone application called Psoriasis New World, and the study includes multiple centers. Participants will be assessed regularly for treatment effectiveness using measures such as the Psoriasis Area and Severity Index PASI, Physician and Investigator Global Assessments, Body Surface Area affected, and Dermatology Life Quality Index. Adverse events and laboratory tests, including liver function, will be monitored throughout up to 12 months. The primary outcome is the percentage of patients achieving complete skin clearance PASI 100 at 6 months, with additional follow-up evaluations at 12 months.

Researchers are evaluating the efficacy, safety, and immune response of a bivalent enterovirus-inactivated vaccine Vero cell designed to prevent Hand, Foot, and Mouth Disease HFMD caused by CA16 infection in healthy children aged 6 to 71 months. This Phase III, multicenter, randomized, double-blind, controlled trial compares this investigational vaccine to an existing EV71-inactivated vaccine to see if it provides better or similar protection and immune response. Participants will be randomly assigned to receive either two doses of the bivalent enterovirus vaccine or two doses of the EV71 vaccine, given one month apart. The study includes a large group of 8000 children divided by age and vaccination history. After vaccination, children will be monitored through two epidemic seasons for signs of enterovirus infection, with swabs collected for lab testing when symptoms appear. Researchers will closely track any adverse events following vaccination, and subsets of participants will provide blood samples to assess detailed immune responses over time. During the study, guardians will report symptoms and adverse events, and researchers will collect throat or rectal swabs for lab confirmation if infection is suspected. Safety monitoring includes immediate and longer-term follow-up for side effects. Blood samples from selected participants will measure antibody levels at multiple time points up to 12 months after vaccination. The main outcomes include vaccine effectiveness against CA16-caused HFMD and immune responses to EV71. Participation involves regular visits, sample collections, and monitoring for up to two years post-vaccination.

Researchers are conducting an open, single-arm Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics, and preliminary effectiveness of FS-8002, alone and in combination with Toripalimab Injection and chemotherapy, in patients with advanced solid tumors. This study aims to better understand how these therapies work and their potential impact on patients who have not responded to or cannot tolerate standard treatments. Participants will receive FS-8002 injection every three weeks, either alone or combined with Toripalimab Injection, with some also receiving chemotherapy chosen by their doctor. Treatment continues until the patient experiences disease progression, unacceptable side effects, death, loss of follow-up, voluntary withdrawal, or the study ends. The study includes a dose escalation phase with six dose groups involving 42 patients to determine the best dose levels. Throughout the study, participants will be closely monitored with regular assessments of drug levels in the blood, side effects, and tumor responses using recognized criteria. Researchers will evaluate multiple outcomes including maximum tolerated dose, dose-limiting toxicities, adverse events, and various measures of tumor control and patient survival over one to two years. Participants will have ongoing evaluations during treatment and follow-up periods to track safety and effectiveness.

Researchers are evaluating the combination of lasofoxifene and abemaciclib compared to fulvestrant and abemaciclib for treating pre- and postmenopausal women and men with locally advanced or metastatic estrogen receptor positive ERhuman epidermal growth factor 2 negative HER2- breast cancer who have an ESR1 mutation and have previously been treated with ribociclib or palbociclib. The study aims to compare the effectiveness, safety, and tolerability of these two treatment combinations. Participants are randomly assigned to one of two groups one receives 5 mg daily oral lasofoxifene plus oral abemaciclib 150 mg twice a day the other receives fulvestrant 500 mg via intramuscular injections on Days 1, 15, and 29 and then monthly thereafter, combined with oral abemaciclib 150 mg twice a day. This open-label study assesses these treatments over approximately three years. During the trial, participants will be monitored through regular assessments including tumor measurements, survival tracking, quality of life questionnaires, and evaluation of adverse events. Researchers will measure progression-free survival as the primary outcome and also track response rates, overall survival, treatment duration, and time to chemotherapy. Brain metastases patients meeting specific criteria are allowed, and safety is closely observed throughout the study period which may last up to about three years.