Tonghua

Researchers are conducting a phase I/II clinical trial to study LBL-024 in patients with advanced malignant tumors. This trial aims to assess the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary effectiveness of LBL-024 in patients who have failed standard treatments or for whom no standard treatment is available or applicable. The study includes different phases to explore dose escalation, safety, and efficacy, with a focus on patients with advanced solid tumors. The treatment involves administering LBL-024 by injection every three weeks. The trial is divided into two parts: Part I includes a phase I/IIa dose escalation and pharmacokinetic expansion to evaluate safety and initial efficacy, while Part II is a phase IIb single-arm pivotal study to further assess the treatment in this patient population. Participants will be monitored through various assessments including safety evaluations, pharmacokinetic testing, and measuring tumor response. Key outcomes include determining the maximum tolerated dose, dose-limiting toxicities within three weeks of the first dose, and the objective response rate. Follow-up visits occur 30 days after treatment discontinuation or withdrawal to evaluate ongoing safety and treatment effects. The study requires participants to be adults aged 18 to 80 years with adequate organ function and an expected survival of at least 12 weeks.

Researchers are evaluating the safety and effectiveness of a combination treatment using selinexor, azacitidine, and venetoclax for adults newly diagnosed with acute myeloid leukemia (AML) who have not received prior treatment. This Phase 2, prospective, single-arm, multi-center clinical trial aims to understand how well this combination works specifically for patients who are either not suitable for intensive chemotherapy or who refuse it. The study focuses on measuring the percentage of participants who achieve complete remission from the start of the study up to about two years or until death. The treatment regimen involves giving selinexor orally at 60 mg on days 3, 10, and 17; azacitidine intravenously at 75 mg/m2 on days 1-3, 8-9, and 15-16; and venetoclax orally starting with 100 mg on day 1, 200 mg on day 2, and 400 mg on days 3-14. Each cycle lasts 28 days. Participants may proceed to receive a transplant at any time after achieving complete remission. Those who do not undergo transplant will continue treatment until their disease worsens or side effects become unacceptable. During the study, participants will be closely monitored through various evaluations to assess treatment response and safety. Researchers will track remission status, disease progression, and any adverse effects. The total study period involves treatment cycles and follow-up lasting up to approximately two years. This ongoing monitoring helps determine the overall benefit and risks of the combination therapy for AML patients who are treatment naive.

Researchers are investigating ZL-1310 as a single drug and in combination with Atezolizumab, with or without Carboplatin, to assess safety, effectiveness, and how the drugs behave in the body in people with extensive small cell lung cancer. This is an open-label, phase 1 study involving multiple doses to evaluate these treatments in different combinations for this serious lung cancer type. The study has several parts testing ZL-1310 alone, with Atezolizumab, and with both Atezolizumab and Carboplatin. Participants may receive the drugs in ascending doses to find safe levels and monitor how these treatments work together. Some parts of the study include participants who have received no prior systemic treatment, while others include those who have had previous chemotherapy or immunotherapy. The study carefully tracks the effects of these treatments over time, including any side effects and the cancer's response. Participants will be monitored up to 24 months for side effects like dose-limiting toxicities, treatment-related adverse events, and serious adverse events. The study measures tumor response using RECIST v1.1 criteria based on investigator assessments to understand treatment impact. Participants undergo scans, biopsies, and provide tumor tissue samples, with health and performance status evaluated regularly throughout the study to ensure safety and measure outcomes.

Researchers are evaluating the safety and effectiveness of TiLOOP4 Bra mesh in women undergoing two-stage expander-implant breast reconstruction following nipple or skin-sparing mastectomy. This randomized controlled study aims to determine whether using TiLOOP Bra mesh with tissue expanders can lower the rates of capsular contracture, improve expansion efficiency, and result in better cosmetic outcomes. The trial focuses on adult female breast cancer patients without distant metastasis and with good overall health. The study compares two types of procedures: one where the tissue expander is placed under the chest muscle with the addition of TiLOOP Bra mesh, and another where the expander is placed sub-pectorally without the mesh, only covered by muscle and fascia. The mesh is applied during the first stage of reconstruction immediately after mastectomy. The treatment phase involves monitoring the expansion and recovery process to assess both safety and effectiveness. Participants will be followed for up to 24 months after surgery to monitor complication rates and for about one year to assess how efficiently the tissue expands. Researchers will collect data on complications, expansion progress, and aesthetic results. Throughout the study, patients' health status and surgical outcomes will be carefully evaluated to ensure safety and to compare the benefits of using the TiLOOP Bra mesh in breast reconstruction.

Researchers are evaluating MCLA-129, a human bispecific antibody targeting EGFR and cMet, in patients with advanced solid tumors including non-small cell lung cancer (NSCLC), head and neck cancer, and colorectal cancer. This open-label, multicenter Phase I/II study aims to assess the safety, pharmacokinetics, and anti-tumor activity of MCLA-129. The study includes two parts: Part I focuses on dose finding and safety in patients with EGFR or MET positive tumors, and Part II further evaluates efficacy and safety in specific patient cohorts with advanced NSCLC and other solid tumors based on biomarker profiles. MCLA-129 is given as an intravenous infusion on a 28-day cycle. Part I includes a dose escalation and expansion phase to determine the maximum tolerated dose and observe dose-limiting toxicities during the first 28 days. Part II expands into parallel cohorts defined by specific genetic markers and tumor types, such as patients with EGFR mutations resistant to prior therapies, MET amplification, or exon 14 skipping mutations, as well as those with advanced colorectal cancer or other solid tumors that have failed standard treatments. Participants will undergo regular assessments including tumor measurements every 6 weeks to monitor response and disease progression for up to approximately two years. Safety is closely monitored during treatment and for 30 days after the last dose. Other evaluations include pharmacokinetic sampling and adverse event tracking. The study requires participants to meet certain health status, organ function, and biomarker criteria and involves follow-up procedures to assess long-term outcomes and treatment effects.

Researchers are investigating the effects of transcranial current stimulation on insomnia disorder, a common sleep problem. While this noninvasive treatment shows promise, the specific impact on brain mechanisms related to sleep, brain structure, and neurobiology is not yet fully understood. The study aims to explore these effects in detail. Participants will receive either real transcranial current stimulation or sham stimulation. The active treatment consists of daily 20-minute sessions with a 1.1-mA device applied consecutively. The sham group will wear the device without receiving actual stimulation. This approach helps compare the true effects of the treatment against placebo. Throughout the study, researchers will measure changes in brain activity using several neuroimaging markers, including blood-oxygen-level-dependent signals, functional connectivity, low-frequency brain activity, regional brain homogeneity, and cerebral autoregulation. These assessments will be conducted at two weeks and three months to monitor short- and longer-term effects. Participants will also complete questionnaires to support the evaluation of treatment impact and safety.