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Clinical Trial News

Superpulse Thulium Fiber Laser Shows Promise in Ureteroscopic Lithotripsy: A Randomized Trial

  • A randomized controlled trial is underway comparing superpulse thulium fiber laser (SPTL) to holmium laser lithotripsy for treating upper urinary tract stones.
  • The study aims to evaluate the clinical efficacy and safety of SPTL, focusing on stone-free rate, operative time, and complication rates.
  • The trial incorporates rigorous data monitoring and adverse event reporting to ensure patient safety and data integrity.
  • Statistical analysis will include chi-square tests, t-tests, and Wilcoxon rank sum tests, with multiple imputation used to manage missing data.

Levothyroxine Use Linked to Bone Density Loss in Older Adults with Normal Thyroid Function

  • A new study reveals that levothyroxine use is associated with bone density loss in older adults, even when thyroid function is within the normal range.
  • The research included 81 levothyroxine users and 364 non-users, with a median age of 73, monitored over a median of 6.3 years.
  • Findings suggest a need for careful risk-benefit assessment of levothyroxine treatment in older adults, considering potential adverse effects on bone health.
  • Regular monitoring of thyroid function is recommended for individuals taking levothyroxine to mitigate potential bone loss.

SCG101 Shows Promise in Phase I Trial for HBV-Related Hepatocellular Carcinoma

• SCG101, an autologous HBV-specific TCR-T cell therapy, demonstrated substantial antiviral activity in patients with advanced HBV-related hepatocellular carcinoma. • In a Phase I trial, 92% of subjects experienced a significant decrease in serum HBsAg levels, with some achieving complete HBsAg loss within 21 days. • The therapy was generally well-tolerated, with adverse events consistent with the targeted immune activation and clearance of diseased cells. • SCG101 has received trial approvals from regulatory bodies including the China NMPA, the US FDA, the Hong Kong DOH, and the Singapore HSA.

FDA Approves Zanidatamab (Ziihera) as First HER2-Targeted Bispecific Antibody for Biliary Tract Cancer

• The FDA granted accelerated approval to zanidatamab (Ziihera) for HER2-positive biliary tract cancer (BTC), marking it the first dual HER2-targeted bispecific antibody approved for this indication. • Approval was based on the HERIZON-BTC-01 trial, which showed a 52% objective response rate and a 14.9-month median duration of response in previously treated patients. • Zanidatamab's approval highlights the increasing role of bispecific antibodies in oncology, offering a novel approach to target cancer cells more precisely and effectively. • Continued approval may be contingent on confirmatory trials, including the Phase 3 HERIZON-BTC-302 trial, evaluating zanidatamab in combination with standard-of-care therapy.

Cysteamine Ophthalmic Solution Shows Promise in Japanese Cystinosis Patients

  • A Phase III study in Japan evaluated cysteamine hydrochloride 0.55% ophthalmic solution for treating corneal cystine crystals in cystinosis patients.
  • The study showed a decrease in corneal crystal density and improvement in photophobia, suggesting potential efficacy in Japanese patients.
  • The ophthalmic solution demonstrated an acceptable safety profile, with most adverse events being eye-related and manageable.
  • These findings support the use of cysteamine eye drops for managing ocular manifestations of cystinosis, a rare genetic disorder.

Peer Education Improves Medication Adherence and Cost-Effectiveness in Elderly Hypertensive Patients

  • A randomized clinical trial demonstrated that peer-led education significantly improved medication adherence among elderly patients with hypertension.
  • The study involved 74 participants and compared peer-led sessions to traditional nurse-led education, both based on Ministry of Health guidelines.
  • Cost-effectiveness analysis revealed that peer education was a more efficient method for enhancing medication adherence in this population.
  • The findings suggest peer education as a valuable strategy for hypertension management in elderly patients, offering both clinical and economic benefits.

TiCARos Unveils Switchable CAR-T Therapy Demonstrating Enhanced Safety and Efficacy in Solid Tumors

  • TiCARos' switchable CAR-T technology overcomes on-target off-tumor toxicity, a major limitation in existing CAR-T therapies, particularly for solid cancers.
  • The novel approach uses a chemically tagged cotinine adapter to indirectly target cancer cells, sparing normal tissues and reducing toxicity in animal studies.
  • A suicidal switch mechanism provides an added layer of safety, allowing for the removal of CAR-T cells if necessary, enhancing the therapeutic control.
  • Human T-cell trials confirmed the efficacy and safety of the switchable CAR-T system, suggesting its potential for treating both solid tumors and hematologic cancers.

Transferrin Receptor-Targeted ASOs Show Promise in Crossing the Blood-Brain Barrier

  • Researchers have developed antisense oligonucleotides (ASOs) conjugated with a transferrin receptor (TfR)-targeting antibody fragment for enhanced brain delivery.
  • Intravenous administration of these TfR-ASO conjugates in mice demonstrated effective ASO distribution throughout the brain.
  • The TfR-ASO conjugates led to significant target mRNA reduction in the brain, showcasing their potential for treating neurological disorders.
  • This targeted delivery approach may improve the efficacy and reduce systemic exposure of ASO therapeutics for CNS diseases.

Leclaza Downstages Lung Cancer in 55% of Patients in Preoperative Trial

  • A Korean study found that nine weeks of Leclaza treatment can lower the stage of inoperable lung cancer patients with EGFR mutations, making them eligible for surgery.
  • The NeoLazBAL phase 2 trial used lung lavage fluid biopsies to detect EGFR mutations and guide Leclaza treatment in suspected lung cancer patients.
  • Results showed a 55.8% partial remission rate with Leclaza, and surgical pathology confirmed lung adenocarcinoma in all patients who underwent resection.
  • Lung lavage fluid biopsy demonstrated 77.3% sensitivity for detecting EGFR mutations in stage I NSCLC, offering a less invasive diagnostic approach.

AstraZeneca's AZD1390 to Be Evaluated in GBM AGILE Trial for Glioblastoma

  • AstraZeneca's AZD1390 will be assessed in the Glioblastoma Adaptive Global Innovative Learning Environment (GBM AGILE) trial to treat newly diagnosed glioblastoma patients.
  • The global adaptive platform trial aims to accelerate the identification and confirmation of effective glioblastoma therapies through its unique design.
  • AZD1390, a brain-penetrant ATM kinase inhibitor, impedes ATM-dependent signaling and DNA repair, potentially enhancing glioblastoma treatment.
  • Recruitment for the AZD1390 arm of the trial is anticipated to commence in the second quarter of next year, with data potentially supporting regulatory submissions.

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