Dingxi

Researchers are evaluating the safety, tolerability, pharmacokinetics, immune response, and early clinical effects of BNT3212, both alone and combined with pumitamig, in adults with advanced solid tumors who have exhausted other treatment options. This first-in-human, open-label study includes dose escalation and expansion phases to find the best dose and assess how the treatments work across different tumor types. The study is divided into four parts Part A and Part B focus on BNT3212 as a single therapy, with dose escalation followed by dose expansion in specific tumor types. Parts C and D evaluate the combination of BNT3212 with a fixed dose of pumitamig, again starting with dose escalation and then expansion cohorts. Treatments are given by intravenous infusion, and doses are adjusted to find the maximum tolerated dose and recommended dose for further study. Participants will undergo regular monitoring including safety assessments, blood tests to study drug levels and immune reactions, and imaging to measure tumor response. Researchers will track side effects, treatment interruptions, and response rates over approximately 31 months. The study also measures progression-free and overall survival. Continuous evaluation of safety and clinical data supports participant well-being throughout the trial.

Researchers are evaluating how long adult participants with KRASNRAS and BRAF wild-type unresectable or metastatic left-sided colorectal cancer remain disease-free when treated with different combinations of drugs. The study compares amivantamab combined with chemotherapy regimens mFOLFOX6 or FOLFIRI versus cetuximab combined with the same chemotherapy regimens. This phase 3 trial aims to understand which treatment approach may better delay cancer progression. Participants will be randomly assigned to one of two treatment groups. One group receives amivantamab along with chemotherapy cycles consisting of 5-fluorouracil, leucovorin calcium or levoleucovorin, and oxaliplatin or irinotecan hydrochloride, repeated every 28 days. The other group receives cetuximab combined with the same chemotherapy regimens, also in 28-day cycles. Treatments continue until imaging shows disease progression or other criteria require stopping. During the study, participants will undergo regular assessments including radiographic imaging to monitor disease status and treatment effects. Researchers will measure progression-free survival for up to over 4 years, along with other outcomes such as overall survival, response rates, duration and time to response, and quality of life using validated questionnaires. Safety will be monitored through adverse event reporting and laboratory tests, with follow-up continuing for several years to capture long-term results.

Researchers are evaluating brenipatide, compared to a placebo, for adults with Alcohol Use Disorder AUD and hazardous alcohol use. This phase 3 study aims to assess whether brenipatide affects drinking patterns and cravings over approximately 56 weeks. The study is sponsored by Eli Lilly and Company and involves participants motivated to reduce or stop alcohol consumption. Participants receive escalating doses of brenipatide or placebo via subcutaneous injection. The study includes two experimental periods with LY3537031 brenipatide and a placebo group, all administered by injection. Participants who cannot self-inject may have assistance from a trained support person. The treatment phase lasts up to 56 weeks. During the study, participants attend scheduled visits and complete questionnaires and diaries to track alcohol use and cravings. Researchers monitor changes in drinking patterns using the Timeline Followback Method and assess alcohol craving, health outcomes, body weight, and potential immune responses to the drug. Safety and pharmacokinetics are also evaluated throughout the study duration.

Researchers are evaluating brenipatide for adults with moderate-to-severe Alcohol Use Disorder AUD to see how it compares to a placebo in effectiveness and safety. This Phase 3, multicenter, randomized, double-blind study is led by Eli Lilly and Company and aims to better understand treatment options for AUD. Participants in this study will be adults aged 18 to 75 years and will remain in the study for about 56 weeks. Participants will receive either brenipatide or a placebo through subcutaneous injections. The study has multiple treatment periods with escalating doses of brenipatide administered under medical supervision. Both the active drug and placebo are given by injection under the skin. The study uses a randomized design to assign participants to one of the study groups to compare outcomes. During the study, participants will be regularly assessed using questionnaires and diaries to track drinking patterns, alcohol cravings, and overall health. Researchers will also monitor changes in alcohol consumption, body weight, and health survey scores. Blood tests will check drug levels and the presence of antibodies against brenipatide. Safety and treatment effects will be observed for up to 56 weeks, with study visits scheduled throughout this period.

Researchers are evaluating the addition of Saruparib AZD5305 to standard radiation therapy RT and androgen deprivation therapy ADT for men with high-risk or very high-risk localized or locally advanced prostate cancer who have a BRCA1 or BRCA2 mutation. The study aims to determine if Saruparib improves metastases-free survival compared to placebo when added to these treatments. This phase 3 trial involves approximately 700 adult male participants. Participants are randomly assigned to receive either Saruparib or a matching placebo alongside physicians choice of ADT, with or without abiraterone and prednisoneprednisolone, depending on their cohort. Cohort A includes those receiving RT and continuous ADT, while Cohort B includes participants receiving RT, ADT, and abiraterone. Saruparib and placebo are administered orally. Treatment continues with close monitoring throughout the study. Participants will undergo scans including CT or MRI, bone scans, and PSMA-PET after their planned RT to confirm eligibility and monitor disease status. They will be followed for survival and disease progression for up to approximately 11 years. Researchers will assess metastasis-free survival, overall survival, prostate cancer-specific survival, biochemical recurrence, physical function, and urinary symptoms. Safety and drug levels will also be monitored. An independent committee will review safety and efficacy regularly throughout the trial.

Researchers are evaluating the effectiveness of claseprubart DNTH103 compared to a placebo in adults with chronic inflammatory demyelinating polyneuropathy CIDP. This Phase 3 study aims to assess treatment outcomes in participants with typical CIDP or certain CIDP variants, focusing on improving disease activity and disability measures. The study consists of several periods Part A includes an open-label phase lasting up to 13 weeks where participants receive an intravenous loading dose of claseprubart followed by subcutaneous injections every two weeks. Part B is a randomized, placebo-controlled, double-blind treatment phase lasting up to 52 weeks for those who respond to treatment in Part A, with participants receiving either claseprubart or placebo subcutaneously every two weeks. Eligible participants may then join an optional open-label extension lasting up to 104 weeks, continuing claseprubart treatment subcutaneously every two weeks, followed by a safety follow-up period of 40 weeks. Participants will undergo regular assessments throughout the study, including evaluations of disease relapse using the Adjusted Inflammatory Neuropathy Cause and Treatment INCAT score, disability scales, grip strength measurements, quality of life, fatigue severity, and antibody levels. Safety monitoring involves tracking adverse events and drug serum concentrations. The total study duration can extend up to approximately 209 weeks, including all treatment and follow-up phases, with careful monitoring of participants neurological stability and treatment responses.

Researchers are evaluating a medicine called nerandomilast for adults with systemic sclerosis, a condition affecting the skin and internal organs. The study focuses on people with limited or diffuse cutaneous systemic sclerosis who have had symptoms for less than 7 years. The goal is to see if nerandomilast helps improve symptoms and slows disease progression while assessing how well the medicine is tolerated. Participants are randomly assigned to one of two groups one takes nerandomilast tablets, and the other takes placebo tablets that look identical but do not contain medicine. Tablets are taken twice daily. The study lasts from 1 to about 4 years, with regular visits to the study site and phone check-ins. During visits, participants have blood tests and assessments of skin thickening, lung function, and organ health to monitor changes and treatment effects. Throughout the study, doctors monitor participants overall health and any side effects. They regularly assess safety and tolerability of the treatment. The main outcome measured is the time to disease progression or death over up to 4 years. Other outcomes include changes in skin scores, lung capacity, physical function, and disease impact questionnaires. Participants health is closely followed during the study period.

Colorectal cancer CRC is a common and growing health concern in China, with its incidence increasing faster than the global average. Early detection through screening is crucial to reduce the disease burden, especially in average risk populations where most sporadic cases occur. This trial aims to compare different colorectal cancer screening methods to find effective approaches for the average risk population in China. Participants will be randomly assigned to one of three screening groups a colonoscopy group that receives a single colonoscopy in the first year a FIT group that undergoes annual fecal immunochemical tests for four years, with positive results followed by diagnostic colonoscopy and a FIT plus blood test group that combines annual FIT and blood tests detecting cfDNA methylation, also followed by colonoscopy if positive. All groups will have suspicious lesions removed and examined, followed by annual follow-ups and long-term monitoring. During the study, participants will provide fecal, blood, and tissue samples. Researchers will assess colorectal cancer mortality over 10 years as the primary outcome, along with detection rates of advanced lesions, population compliance, cancer stages, incidence rates, quality of life, and cost-effectiveness over 4 to 10 years. This comprehensive approach includes a 4-year screening phase and extended follow-up to monitor outcomes and safety.

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 effects of a long-term infusion of lidocaine on postoperative chronic pain, quality of life, and survival among elderly patients undergoing colorectal cancer surgery. This study is a follow-up observation of patients previously enrolled in a related trial, focusing on how lidocaine impacts pain and survival over time. The goal is to better understand the long-term benefits and outcomes of using lidocaine in this surgical setting. Participants are randomly assigned to one of two groups the lidocaine group or the placebo group. Those in the lidocaine group receive a continuous infusion of lidocaine at a dose of 1.5 mgkgh during the surgery, followed by a postoperative analgesia pump containing lidocaine, sufentanil, and granisetron for 72 hours. The placebo group receives an equivalent volume of normal saline during surgery and a postoperative device with sufentanil and granisetron without lidocaine. The treatments are given under double-blind conditions. Participants will be followed from three months up to five years after surgery to assess chronic pain occurrence, the impact of pain on quality of life, and survival outcomes including relapse-free and overall survival. Researchers will use tools such as the Brief Pain Inventory to measure pain interference and monitor neuropathic pain prevalence. The study includes regular assessments and long-term follow-up to understand the lasting effects of lidocaine infusion on recovery and survival.