Tonghua

Researchers are evaluating AHB-171 Injection in a Phase I clinical trial to assess its safety, tolerability, immune response, and pharmacokinetics in both healthy adults and adults with chronic hepatitis B CHB. The study also aims to explore the preliminary effectiveness of AHB-171 in CHB participants. This trial includes two parts Part A with healthy participants and Part B with CHB participants receiving background treatment. Participants receive AHB-171 Injection or placebo via subcutaneous injection. CHB participants also continue stable treatment with nucleostide analogue NA orally. Part A focuses on single ascending doses in healthy adults, while Part B involves multiple ascending doses in CHB participants. The study monitors participants for up to 16 weeks in Part A and up to 48 weeks in Part B, assessing various safety and pharmacokinetic parameters. During the study, participants undergo laboratory tests, physical exams, vital sign checks, electrocardiograms, and ultrasound assessments. Researchers track adverse events and measure drug levels in the blood and urine, as well as immune responses against AHB-171. In CHB participants, viral markers and liver function tests are monitored to evaluate treatment effects. Participants are followed closely throughout the study duration, which may last up to 48 weeks depending on the group.

Researchers are evaluating the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary efficacy of LBL-024 in patients with advanced malignant tumors in a phase III clinical study. This study includes patients who have failed previous standard treatments, lack standard treatment options, or are not suitable for such treatments. The trial consists of two parts a phase IIIa dose escalation and pharmacokinetic expansion phase, and a phase IIb pivotal single-arm clinical study. Participants receive LBL-024 injections at the maximum tolerated dose every three weeks. The phase IIIa part focuses on dose escalation, safety, and preliminary efficacy, while the phase IIb part serves as a single-arm registry study to further assess the treatment. The study evaluates the drugs pharmacokinetic characteristics and immune response throughout treatment. During the study, participants are closely monitored for dose-limiting toxicities within three weeks of the first dose and maximum tolerated dose completion. Researchers assess objective response rate, adverse events, immunogenicity, disease control rate, and progression-free survival. Follow-up visits occur up to 30 days after treatment discontinuation or withdrawal. The total study duration extends until December 2026.

This research aims to evaluate the safety and effectiveness of combining selinexor with azacitidine and venetoclax in adults newly diagnosed with acute myeloid leukemia AML who have not received prior treatment. The study is a prospective, single-arm, multi-center clinical trial focusing on patients who are either ineligible for or refuse intensive chemotherapy. It is designed to gather data on how well this combination works and its safety profile in this patient group. Participants will receive selinexor orally at 60 mg on days 3, 10, and 17 azacitidine intravenously at 75 mgm2 on days 1-3, 8-9, and 15-16 and venetoclax orally starting at 100 mg on day 1, increasing to 200 mg on day 2, and 400 mg on days 3-14 within each 28-day treatment cycle. Those who achieve complete remission may undergo a transplant at any time, while others will continue treatment until the disease progresses or unacceptable side effects occur. During the study, participants will be closely monitored for treatment response and safety through assessments including remission rates up to about two years. Secondary measures include overall survival, response rates, minimal residual disease negativity, and recurrence-free survival over approximately four years. The total participation time varies based on individual outcomes, with ongoing evaluations to track effectiveness and side effects throughout the study period.

Researchers are evaluating ZL-1310 alone and in combination with Atezolizumab, with or without Carboplatin, in people with extensive small cell lung cancer SCLC. This open-label, phase 1 study aims to assess the safety, effectiveness, and how the body processes these treatments. Participants include those with metastatic or extensive-stage SCLC, either previously treated or newly diagnosed depending on the study part. Participants may receive ZL-1310 as a single drug, combined with Atezolizumab, or combined with both Atezolizumab and Carboplatin. The study includes several parts dose escalation to find safe dose levels, dose expansion, and dose extension phases. Some groups receive induction therapy followed by maintenance therapy. The exact dosing and combinations vary by study part and are adjusted based on emerging data. During the study, participants undergo regular assessments including tumor scans CT, PETCT, or MRI, tumor biopsies or tissue sample collection, and monitoring of side effects and treatment responses per RECIST v1.1 criteria. Researchers track safety outcomes such as dose-limiting toxicities and adverse events for up to 24 months, along with measures of tumor control, response rates, and survival. Participants are monitored closely throughout treatment and follow-up periods lasting up to two years.

Researchers are studying 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 multi-center, open-label Phase III study aims to evaluate the safety, pharmacokinetics, and antitumor activity of MCLA-129. The study includes patients with tumors that have progressed after standard treatments or are intolerant to them. The study has two parts Part I involves dose escalation and dose expansion to determine safe and effective dose levels of MCLA-129 administered by intravenous infusion every one or two weeks. Part II is a cohort expansion phase assessing efficacy, safety, and pharmacokinetics at the recommended Phase II dose in groups of patients with specific biomarker profiles, such as EGFR mutations or MET amplification. Participants will receive MCLA-129 infusions in 28-day cycles and undergo regular assessments including tumor measurements, safety monitoring, and pharmacokinetic testing. Primary outcomes include dose-limiting toxicity, maximum tolerated dose, overall response rate, and treatment-emergent adverse events. Secondary outcomes measure drug levels, response duration, progression-free survival, and overall survival. Follow-up continues for approximately two years after treatment initiation to monitor effects and safety.

Researchers are evaluating plozasiran in adults with severe hypertriglyceridemia SHTG who have experienced at least two prior acute pancreatitis AP events, with one event occurring within the last 12 months before screening. The study aims to assess the efficacy and safety of plozasiran compared to a placebo in reducing AP events and managing triglyceride levels. About 288 adult participants will be involved in this randomized, double-blind, phase 3 clinical trial. Participants will be randomly assigned to receive either plozasiran 25 mg or a matching placebo by subcutaneous injection every three months Q3M. They will be counseled to maintain a low-fat diet and continue their prescribed lipid and triglyceride-lowering medications throughout the study. After the double-blind treatment period or upon experiencing a confirmed AP event, participants will enter a 12-month open-label extension, receiving plozasiran 25 mg by subcutaneous injection every three months. During the study, participants will be regularly monitored for the time to first AP event, changes in fasting serum triglyceride levels, cardiovascular events, patient-reported productivity, and health status. Safety assessments will include tracking treatment-emergent adverse events. The study will last approximately up to 62 months, including the double-blind and open-label phases, with ongoing evaluations and follow-up visits to assess treatment effects and participant health.

Researchers are investigating the effects of transcranial current stimulation on insomnia disorder, a common sleep problem. This study aims to understand how this noninvasive device impacts brain activity and neurobiological changes related to sleep. Although this treatment is promising, its specific effects on brain structure and function during sleep are still unclear. Participants will receive either active or sham transcranial current stimulation for 14 consecutive days. Each session lasts 20 minutes with a 1.1-mA current, including 30 seconds of gradual current changes at the start and end. The sham group will wear the device without any stimulation. The study is randomized and quadruple-blinded to compare the outcomes between these two groups. During the study, participants will be assessed at 2 weeks and 3 months after treatment. Researchers will measure brain blood flow signals, brain connectivity, and other brain activity markers using imaging techniques. They will also evaluate insomnia severity, anxiety, depression, sleep quality through polysomnography, and biological factors such as hormone and protein levels in the blood. This comprehensive monitoring will help understand the treatments effects and safety over time.