Birtinya

Researchers are evaluating new treatment options for adults with locally advanced or metastatic colorectal cancer that cannot be removed by surgery and has a specific KRAS G12C gene mutation. This study compares the safety and effectiveness of adding calderasib and cetuximab, both targeted therapies, to a standard chemotherapy regimen called mFOLFOX6. The goal is to see if this combination can help patients live longer without their cancer growing or spreading compared to current treatments that may include mFOLFOX6 with or without bevacizumab. The study has two parts. It involves treatment with calderasib taken as an oral tablet, cetuximab given according to standard procedures, and mFOLFOX6 chemotherapy combining oxaliplatin, leucovorin/levofolinate calcium, and 5-fluorouracil. Some participants may receive bevacizumab or a bevacizumab biosimilar as part of the comparison. The treatments are given following approved dosing schedules. This design allows researchers to assess the safety and tolerability of these drug combinations in treating this type of colorectal cancer with the KRAS G12C mutation. Participants will be monitored for side effects, treatment tolerability, and cancer progression over a period that may last up to about 44 months. Researchers will track outcomes such as how many participants experience dose-limiting toxicities or adverse events, how many stop treatment due to side effects, and progression-free survival time. Assessments include health evaluations, laboratory tests, and imaging to observe cancer status. This long-term follow-up aims to understand both safety and effectiveness of the treatment combinations.

Researchers are conducting a phase 1/2 multicenter, open-label clinical trial to study IBI130 in adults with unresectable, locally advanced, or metastatic solid tumors. The study aims to find the maximum tolerated dose and recommended phase 2 dose of IBI130 during phase 1, and then evaluate its safety, tolerability, and potential effectiveness at the recommended dose in phase 2. Approximately 150 patients will participate in the phase 2 portion after initial dose escalation and expansion with 20 to 182 subjects in phase 1. Participants will receive IBI130 until they experience unacceptable side effects, disease progression, withdraw consent, face other reasons to stop, or reach a treatment limit of 24 months, whichever comes first. The study includes dose escalation and expansion to determine safe dosing, followed by treatment at the recommended phase 2 dose to explore IBI130's effects on certain solid tumors. During the trial, participants will be monitored for adverse events up to 30 days after their last dose. They must be able to provide informed consent, have good performance status, and adequate organ function. Safety and tolerability will be closely tracked, with ongoing assessments to ensure participant well-being throughout the treatment and follow-up periods.

Researchers are evaluating the effects of oral neflamapimod, a specific inhibitor of the enzyme p38 alpha kinase, on recovery after moderate to severe acute ischemic stroke. The study aims to determine whether neflamapimod can improve residual physical disability and cognitive dysfunction following such strokes. This is a Phase 2, double-blind, placebo-controlled clinical trial targeting adults who have recently experienced an ischemic stroke in the brain's anterior circulation. Participants will receive either neflamapimod capsules containing 40 mg of the active drug or placebo capsules that look identical but contain no active ingredients. The treatment will be administered over a 12-week period. The study compares motor recovery and other functional outcomes between the neflamapimod and placebo groups to assess the investigational drug's impact. During the study, participants will undergo various assessments including the Fugl-Meyer Assessment of Motor Recovery, the Timed Up and Go Test, and the National Institutes of Health Stroke Scale motor score. These evaluations will measure changes from baseline to Week 12 to track motor and cognitive recovery. Safety monitoring and adherence will be conducted through regular evaluations. The total participation period covers enrollment through the end of treatment at 12 weeks.

Researchers are evaluating the safety and effectiveness of the WiSE CRT System combined with an intracardiac pacemaker to achieve a totally leadless cardiac resynchronization therapy (CRT) for patients with heart failure. This is a single-arm, prospective, multicenter observational study focused on patients who meet specific guidelines for CRT implantation, including those with certain heart rhythm and heart function characteristics. The study aims to provide a leadless solution that may benefit patients with anatomical or infection-related concerns for traditional devices. Participants will receive the WiSE CRT System, an implantable device that provides left ventricular pacing stimulation, working together with an existing system that provides right ventricular pacing. Together, these devices deliver biventricular pacing to improve heart function. The study involves patients receiving either a new totally leadless CRT implant or an upgrade from a chronic intracardiac pacemaker to CRT. Treatment is delivered through device implantation, with follow-up visits scheduled to monitor outcomes. During the study, participants will be monitored for device- and procedure-related complications at 1 month and 6 months after implantation. Researchers will also assess biventricular capture using a 12-lead ECG at these same time points. Patients will provide consent and undergo assessments according to study protocols, with safety and effectiveness data collected throughout the follow-up period. The total duration and schedule of follow-up visits are designed to ensure careful observation of the devices' performance and patient health.

Researchers are evaluating IBI343, a new investigational drug, in a Phase Ia/Ib, multicenter, open-label study involving participants with locally advanced unresectable or metastatic solid tumors. The study aims to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of IBI343. Participants include those with various solid tumors who have failed or are intolerant to standard therapies, and the study is conducted across multiple countries including China, Australia, and the US. The study includes several parts, including dose escalation, dose expansion, dose optimization, and combination therapy cohorts. IBI343 is administered intravenously every 21 days or every 14 days depending on the study part. Combination therapies with chemotherapy regimens such as FOLFIRINOX/mFOLFIRINOX and mFOLFOX are included in certain cohorts. The study has an initial safety lead-in phase to confirm tolerability, followed by randomized dose optimization stages to determine the recommended Phase 3 dose. Treatments are given in cycles, with specific dosing schedules for each drug involved. Participants will undergo regular assessments including physical exams, vital sign monitoring, laboratory tests, and imaging to measure tumor response based on RECIST criteria. Researchers will track adverse events, dose-limiting toxicities, and treatment-emergent side effects up to 90 days after the last administration, with some outcome measures followed for up to 2 years. The study focuses on determining the objective response rate and safety profile of IBI343 while monitoring participant health and treatment effects throughout the study duration.

Researchers are conducting a Phase 1/2 study to evaluate the safety and tolerability of BDC-4182, an immune stimulating antibody conjugate, in patients with advanced gastric and gastroesophageal cancers. This first-in-human trial aims to find the recommended Phase 2 dose by gradually increasing doses and monitoring participants closely. The study focuses on patients with measurable metastatic or unresectable cancer who have already undergone prior standard treatments or cannot tolerate them. Participants will receive BDC-4182, which combines an anti-claudin 18.2 monoclonal antibody with a TLR 7/8 dual agonist, delivered as a single agent. The study includes a dose escalation phase where participants are enrolled in cohorts until the maximum tolerated dose is found. Additional participants may join backfill cohorts for further safety data or the expansion phase at the recommended dose level. Throughout the study, participants will undergo biopsies or tumor sample collection before enrollment. Researchers will monitor adverse events up to around two years, including serious and dose-limiting toxicities within the first 21 days. Organ function and other health assessments will be performed to ensure safety. The trial carefully tracks treatment effects and tolerability in this patient population over the course of the study.

Researchers are studying adults with confirmed Primary Biliary Cholangitis (PBC) and cirrhosis, a scarring of the liver caused by damage to bile ducts. PBC is a slowly progressing disease that causes bile acid buildup and further liver damage, which can lead to cirrhosis. This study aims to evaluate if elafibranor, a daily medication, can prevent worsening clinical outcomes such as the need for liver transplant or death, compared to a placebo. It also looks at the safety of long-term elafibranor use and its effect on symptoms like itching and tiredness. Participants will take either an 80 mg tablet of elafibranor or a matching placebo once daily for up to 3.5 years in a double-blind setup, meaning neither the participants nor researchers know who receives which treatment. This long-term treatment period is designed to monitor the drug's impact over time. The study includes two groups: one receiving elafibranor and the other receiving placebo, with treatment lasting up to approximately 42 months. During the study, participants will be regularly assessed from the start until 4 weeks after treatment ends, with a maximum involvement of 3.5 years. Researchers will measure event-free survival, tracking if participants avoid clinical events indicating disease worsening. Safety monitoring will include tracking side effects and overall health, while symptom impact will be evaluated. Participants will provide informed consent and follow the study protocol throughout this extended observation period.

Researchers are evaluating the safety and tolerability of DB-1311/BNT324 in adults with advanced or metastatic solid tumors in this Phase 1/2a trial. The study includes a dose-escalation phase to find the maximum tolerated dose and recommended Phase 2 dose, followed by a dose-expansion phase to confirm safety and explore effectiveness, including in prostate cancer patients receiving novel hormone therapy. Additionally, a sub-study will assess the effects of other drugs on DB-1311's behavior in the body. During Phase 1, participants receive increasing doses of DB-1311 administered intravenously using an accelerated titration and classic 3+3 design to determine safe dosage levels. Phase 2a expands on this to further evaluate safety and tolerability, with DB-1311 given alone or combined with hormone therapy drugs such as enzalutamide or abiraterone for prostate cancer. The study also investigates drug interactions with lopinavir/ritonavir and itraconazole. Treatment schedules and dosing details follow the study protocol at multiple centers. Participants will undergo various assessments including safety labs, vital signs, electrocardiograms, heart function tests, and performance status evaluations up to approximately one year after treatment. Researchers will monitor treatment-related toxicities, serious adverse events, and response rates. The involvement includes tumor biopsies for biomarker analysis and adherence to follow-up visits. The total study duration varies by phase, with ongoing safety and efficacy monitoring throughout.

Researchers are evaluating the safety and effectiveness of different doses of ZL-1102 topical gel, a human VH IL-17A antibody fragment, in adults with chronic plaque psoriasis. This phase 2, randomized, double-blind, vehicle-controlled, dose-ranging study involves about 250 patients with plaque psoriasis affecting 3% to 15% of their body surface area, excluding the head. The study aims to compare various doses of ZL-1102 gel to a placebo gel over a 16-week treatment period. Participants are randomly assigned to one of five groups receiving different doses and frequencies of ZL-1102 gel or placebo gel. The treatment arms include ZL-1102 1% gel applied twice daily, ZL-1102 3% gel applied either once or twice daily, and placebo gel applied once or twice daily. Each participant undergoes 16 weeks of topical treatment with their assigned gel. During the study, participants will be regularly assessed for treatment effectiveness and safety. Researchers will monitor the response to treatment at Week 16, focusing on the comparison of different ZL-1102 doses against placebo. Patient evaluations include clinical examinations, laboratory tests, and safety monitoring. Participants are asked to avoid prolonged sun exposure and tanning devices during the study period. The total study duration for each participant is 16 weeks.

Researchers are studying the real-world effectiveness of pegcetacoplan in patients with Paroxysmal Nocturnal Hemoglobinuria (PNH). This long-term, multicenter observational study aims to fill knowledge gaps about how pegcetacoplan works in routine medical practice. It also seeks to provide important information on red blood cell transfusions and healthcare resource use before and after starting pegcetacoplan treatment. Patients who have started pegcetacoplan treatment within the last 12 months or are prescribed it at enrollment will be followed for approximately 36 months. The study will collect both retrospective data from up to 12 months before treatment start and prospective data during treatment, with a total data collection period of up to about 48 months. After stopping pegcetacoplan, patients will remain in the study for 8 weeks to monitor for any adverse events. Participants will attend their usual medical visits, and data from these visits will be collected, including effectiveness measures, safety reports, patient- and clinician-reported outcomes, and healthcare use. The primary outcome includes changes in hemoglobin levels over 6 months from the start of pegcetacoplan treatment. The study plans to enroll about 200 patients across multiple countries, and data collection includes both retrospective and prospective periods, capturing comprehensive information on pegcetacoplan use in real-world settings.