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Clinical Trial News

Elevar Therapeutics Seeks FDA Approval for Rivoceranib and Camrelizumab Combination in Unresectable Hepatocellular Carcinoma

  • Elevar Therapeutics has submitted an NDA to the FDA for rivoceranib in combination with camrelizumab as a first-line treatment for unresectable hepatocellular carcinoma (uHCC).
  • The NDA submission is based on Phase 3 CARES 310 study results, which demonstrated statistically significant improvements in overall and progression-free survival compared to sorafenib.
  • The combination therapy showed a median overall survival of 22.1 months versus 15.2 months for sorafenib, with a hazard ratio of 0.62 (95% CI 0.49-0.80; p<0.0001).
  • Rivoceranib and camrelizumab combination was approved in China in February 2023 as a first-line treatment for liver cancer.

A Study to Evaluate SHR-1210 in Combination With Apatinib as First-Line Therapy in Patients With Advanced HCC

NCT03764293CompletedPhase 3
Jiangsu HengRui Medicine Co., Ltd.
Posted 6/10/2019

Dog Aging Project Explores Rapamycin to Extend Lifespan and Improve Healthspan

  • The Dog Aging Project is studying over 44,000 dogs to understand aging and age-related diseases, aiming to improve both canine and human healthspan.
  • Researchers are investigating rapamycin, a drug known to extend lifespan in lab animals, to see if it can promote healthy aging and longevity in dogs.
  • Early trials of rapamycin in dogs showed improvements in heart function and increased activity levels, with no significant side effects reported by owners.
  • The ongoing TRIAD study, involving 580 dogs, is assessing the impact of rapamycin on lifespan, with results expected in approximately three years.

NIH Awards $7.5M Grant to Advance Vaxxas' HD-MAP Vaccine Technology

  • Vaxxas receives a $7.5 million grant from the NIH to further develop its high-density microarray patch (HD-MAP) vaccine technology.
  • The funding follows promising Phase 1/2 clinical trial results published in The Lancet, supporting the potential of HD-MAP for improved vaccine delivery.
  • The grant will support advanced development and manufacturing scale-up of Vaxxas' needle-free vaccine delivery system.
  • Vaxxas' HD-MAP technology offers the potential for enhanced immune responses and simplified vaccine administration, addressing key challenges in global immunization.

Tucatinib Plus Trastuzumab Shows Promise in HER2-Positive Metastatic Colorectal Cancer

• Tucatinib plus trastuzumab demonstrates clinically meaningful anti-tumor activity in patients with chemotherapy-refractory, HER2-positive metastatic colorectal cancer. • The combination therapy achieved a confirmed objective response rate of 38.1% per blinded independent central review (BICR) in the full analysis set. • Diarrhea was the most common adverse event, with hypertension being the most frequent grade 3 or worse adverse event. • This regimen is the first FDA-approved anti-HER2 therapy for metastatic colorectal cancer, offering a new treatment option.

Tucatinib Plus Trastuzumab in Patients With HER2+ Colorectal Cancer

NCT03043313CompletedPhase 2
Seagen Inc.
Posted 6/23/2017

Viaskin Peanut Allergy Patch Shows Promise in Toddlers

  • A clinical trial reveals that a skin patch, Viaskin, significantly increases peanut tolerance in toddlers with peanut allergies.
  • Approximately 67% of children aged one to three wearing the Viaskin patch for a year could safely ingest more peanut protein than before.
  • The study, involving 362 toddlers across eight countries, offers hope for a new treatment option where few exist for young children.
  • The Viaskin patch represents a potential alternative to strict avoidance, which can significantly impact the quality of life for children and families.

GLP-1 Agonists Gain Traction in Cardiology for Weight Loss and CV Risk Reduction

  • GLP-1 receptor agonists like semaglutide are gaining popularity for weight loss and improving cardiometabolic risk factors in patients with obesity or overweight.
  • Clinical trials such as SELECT and SURMOUNT MMO are investigating the cardiovascular benefits of GLP-1 agonists and tirzepatide in diverse patient populations.
  • Experts emphasize the importance of combining medication with lifestyle interventions for optimal cardiovascular health and addressing the need for cardiometabolic education among cardiologists.
  • Emerging research suggests potential long-term benefits of GLP-1 agonists beyond weight loss, including improvements in heart failure, atrial fibrillation, and metabolic memory.

Novo Holdings Leads $200M Series A Investment in Windward Bio for Advanced Respiratory Treatments

Novo Holdings has invested in a $200M Series A financing round for Windward Bio, a clinical-stage drug development company focused on severe respiratory conditions. Windward Bio's lead candidate, WIN378, is a long-acting monoclonal antibody targeting the TSLP ligand, with potential dosing every six months. The investment aims to advance treatments for severe asthma and COPD, addressing a significant unmet medical need.

MIROCALS Trial Results: Low-Dose IL-2 Shows Potential Benefit for Subset of MND Patients

  • The MIROCALS trial testing low-dose interleukin-2 (IL-2) for motor neurone disease (MND) failed to meet its primary endpoint for the overall population, with results published in The Lancet on May 9, 2025.
  • Post-hoc analysis revealed a potential benefit for patients with slower disease progression, identified by low neurofilament levels, showing 18% higher survival rates and 23% decreased functional decline compared to placebo.
  • The UK MND Clinical Studies Group is currently evaluating the complex findings to determine next steps, with three MND organizations collaborating to expedite access to proven treatments.

Adjuvant Atezolizumab and Bevacizumab Delays Recurrence in Early-Stage HCC

The phase 3 IMBrave050 trial has shown that adjuvant atezolizumab plus bevacizumab significantly improves recurrence-free survival (RFS) in patients with early-stage hepatocellular carcinoma (HCC) at high risk of recurrence after curative resection or ablation. This combination, already a standard-of-care for unresectable HCC, could become a practice-changing treatment option in the adjuvant setting, offering hope for patients with historically poor prognosis.

A Study of Atezolizumab Plus Bevacizumab Versus Active Surveillance as Adjuvant Therapy in Patients With Hepatocellular Carcinoma at High Risk of Recurrence After Surgical Resection or Ablation

NCT04102098Active, Not RecruitingPhase 3
Hoffmann-La Roche
Posted 12/31/2019

A Study of Atezolizumab in Combination With Bevacizumab Compared With Sorafenib in Patients With Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma

NCT03434379CompletedPhase 3
Hoffmann-La Roche
Posted 3/15/2018

FDA Outlines 2023 Guidance for Clinical Trials, Including Decentralized Trials and Psychedelic Research

  • The FDA is set to release long-awaited draft guidance on decentralized clinical trials (DCTs) by the end of 2023, offering clarity and reducing perceived risks.
  • New draft guidance will address psychedelic research, standardizing methodologies and safety considerations for this rapidly growing field.
  • The FDA plans to expand master protocol guidance to non-oncology trials, facilitating data sharing and efficient trial designs across various disease areas.
  • International harmonization efforts are underway with the ICH to refine adaptive clinical trial designs, promoting consistency across regulatory jurisdictions.

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