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Clinical Trial News

Avenzo and Gilead Partner to Evaluate Novel Breast Cancer Combination Therapy

• Avenzo Therapeutics and Gilead Sciences have entered a clinical trial collaboration to study a combination regimen for HR+, HER2- breast cancer. • The regimen will combine Avenzo's investigational CDK2 inhibitor, AVZO-021, with Gilead's Trop-2 directed antibody-drug conjugate, Trodelvy (sacituzumab govitecan-hziy). • Gilead will supply Trodelvy for the study, while Avenzo will be responsible for conducting and sponsoring the trial, maintaining all development and commercial rights for their respective assets. • The Phase Ib study is planned to start in Q4 2024 and will evaluate the combination of AVZO-021 with Trodelvy, as well as CDK4/6 inhibitors.

Invivyd Initiates Phase 1 Trial of VYD2311, a Novel Monoclonal Antibody for COVID-19

  • Invivyd has dosed the first participants in a Phase 1 clinical trial of VYD2311, a next-generation monoclonal antibody (mAb) candidate for COVID-19.
  • The Phase 1 trial is a randomized, blinded, placebo-controlled study evaluating the safety, tolerability, pharmacokinetics, and immunogenicity of VYD2311 in healthy volunteers.
  • VYD2311 was engineered from adintrevimab and aims to provide enhanced protection against current and future SARS-CoV-2 variants, especially for immunocompromised individuals.
  • Preliminary data from the Phase 1 trial are expected in the fourth quarter of 2024, with additional clinical readouts anticipated throughout 2025.

A Study of the Investigational Monoclonal Antibody, VYD2311, in Healthy Participants

NCT06523153Active, Not RecruitingPhase 1
Invivyd, Inc.
Posted 8/28/2024

BlueRock Therapeutics' OpCT-001 Receives FDA Clearance for Phase I/IIa Trial in Primary Photoreceptor Diseases

  • BlueRock Therapeutics received FDA clearance for its IND application for OpCT-001, an iPSC-derived cell therapy targeting primary photoreceptor diseases.
  • The Phase I/IIa trial will assess the safety, tolerability, and efficacy of OpCT-001 in restoring vision for individuals with these conditions.
  • The study will explore various dose levels of OpCT-001 across multiple US sites, evaluating its impact on retinal structure and visual function.
  • OpCT-001, exclusively licensed from FUJIFILM Cellular Dynamics and Opsis Therapeutics, aims to replace degenerated retinal cells with functional ones.

Merck and EyeBio Initiate Phase 2b/3 Trial of Restoret for Diabetic Macular Edema

  • Merck and EyeBio have commenced the Phase 2b/3 BRUNELLO trial to assess Restoret (MK-3000) for treating diabetic macular edema (DME).
  • The BRUNELLO trial is a randomized, double-masked study evaluating the safety and efficacy of two dose levels of Restoret versus ranibizumab.
  • Restoret (MK-3000) is a novel tetravalent, tri-specific antibody that acts as an agonist of the Wnt signaling pathway to restore the blood-retinal barrier.
  • The trial's primary endpoints include safety and mean change in best-corrected visual acuity (BCVA) from baseline to week 52.

A Study to Evaluate the Efficacy and Safety of 2 Doses of EYE103 Compared With Ranibizumab (0.5 mg) in Participants With DME

NCT06571045Active, Not RecruitingPhase 2
EyeBiotech Ltd.
Posted 8/7/2024

Immunic's Vidofludimus Calcium Enters Phase 2 Trial for Post-COVID Syndrome

  • Immunic's vidofludimus calcium (IMU-838) is being evaluated in a Phase 2 trial for Post COVID Syndrome (PCS), with a focus on reducing inflammation and fatigue.
  • The RAPID_REVIVE trial, sponsored by Goethe University Frankfurt, will enroll 376 patients in Germany to assess vidofludimus calcium's impact on physical function.
  • Vidofludimus calcium's potential to prevent Epstein-Barr virus (EBV) reactivation, a possible cause of fatigue in PCS and MS, is also under investigation.
  • Previous data suggest vidofludimus calcium may reduce fatigue in COVID-19 patients, warranting further study in PCS and its implications for multiple sclerosis.

Wearable Heart Monitor Significantly Boosts A-fib Detection, Study Finds

  • A new study reveals that a wearable heart monitor increases the detection rate of atrial fibrillation (A-fib) by more than 50% compared to standard care.
  • The trial, involving over 12,000 participants, aimed to determine if earlier A-fib detection could lead to more timely treatment and reduced stroke risk.
  • Despite the increased detection, the study did not demonstrate a significant reduction in stroke incidence, prompting further research into systematic A-fib screening.
  • Researchers emphasize the need for definitive evidence linking A-fib diagnosis through screening to subsequent anticoagulation treatment and lower stroke risk.

NIH HEAL Initiative Funds Pragmatic Trials for Non-Opioid Pain Management

  • The NIH HEAL Initiative is funding pragmatic clinical trials focused on non-opioid pain management within the NIH-DOD-VA Pain Management Collaboratory.
  • The trials will study non-opioid approaches, including complementary and integrative methods, for managing pain and comorbid conditions in veterans and military personnel.
  • Supported projects will generate data, tools, and best practices to facilitate research partnerships within healthcare systems serving veterans and military families.
  • The application deadline for this funding opportunity, which involves multiple NIH institutes, is November 7, 2024.

Axcellant Launches Clinical Trial for Novel Nuclear Medicine Diagnostic Agent

  • Axcellant, a European CRO, has initiated a clinical trial in the U.S. to evaluate a new radioactive compound for diagnostic use.
  • The trial will involve approximately 20 sites across the East Coast and Midwest, focusing on oncology, cardiology, and neurology.
  • The FDA has reviewed and approved the clinical development plan, paving the way for manufacturing site setup and clinical center activation.
  • The diagnostic agent targets a patient population of over 20 million in the US and 200 million worldwide, potentially changing standard care.

Sabatolimab Shows Promise in Phase I/Ib Trial for Advanced Solid Tumors

  • Sabatolimab, an anti-TIM-3 antibody, demonstrates potential clinical benefit in patients with advanced solid tumors, both as a monotherapy and in combination with spartalizumab.
  • The Phase I/Ib trial assessed the safety and efficacy of sabatolimab, providing valuable insights into its use in diverse cancer types.
  • The study's findings support further investigation of sabatolimab-based immunotherapy regimens in larger clinical trials to validate its therapeutic potential.
  • This research highlights the importance of TIM-3 as a target in cancer immunotherapy and the potential of sabatolimab to improve outcomes for patients with advanced malignancies.

Navigating Trial Endings: MHRA Guidelines for Clinical Trial Termination and Reporting

  • Sponsors must notify the MHRA within 15 days if a trial is terminated early, using the End of Trial Form, and provide a brief explanation for the early termination.
  • Following the declaration of the end of a trial, no further substantial amendments are permitted, and a Clinical Trial Summary Report must be produced within specified timelines.
  • For CTIMPs not submitted through the Combined Review process, the End of Trial Form must be sent to the MHRA within 90 days of the global end of the trial.
  • Notification to the relevant ethics committee, NHS R&D offices, and funders is also required for both early termination and completion of clinical trials.

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