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Clinical Trial News

Advances in Immunotherapy and Precision Medicine Transform Endometrial Cancer Treatment

  • Recent FDA approvals of pembrolizumab, durvalumab, and dostarlimab combined with chemotherapy have significantly improved outcomes for advanced endometrial cancer.
  • Ongoing trials are exploring PARP inhibitors, CDK 4/6 inhibitors, and antibody-drug conjugates to further refine treatment strategies for endometrial cancer.
  • Molecular testing is increasingly crucial for personalizing treatment, with MMR status guiding immunotherapy eligibility and TCGA categories predicting outcomes.
  • Despite progress, the rising incidence of endometrial cancer and the need for better early detection strategies remain critical challenges.

Oncodesign Precision Medicine's OPM-101 Shows Promise in Phase 1 Trial, Phase 1b/2a Planned

  • OPM-101 successfully completed its Phase 1 trial in healthy volunteers, demonstrating a favorable safety profile and target engagement, paving the way for a Phase 1b/2a trial in late 2024 or early 2025.
  • OPM-201, licensed to Servier for Parkinson's disease treatment, is nearing completion of its Phase 1 trial in healthy volunteers, with Servier planning a Phase 1b/2a trial.
  • Oncodesign Precision Medicine secured €8.5 million in public funding for its research programs from innovation financing entities since January 1, 2024, strengthening its financial position.
  • Preclinical studies of OPM-101 and OPM-102 in oncology have shown encouraging results, supporting further development in this therapeutic area.

Beyond Obesity: GLP-1 Drugs Show Promise in Addiction, Neurodegeneration, and More

  • GLP-1 receptor agonists, initially developed for weight loss, are being investigated for their potential to curb cravings and addictions, including alcohol and tobacco use.
  • Clinical trials suggest GLP-1 drugs may reduce the risk of cardiovascular events and kidney complications, potentially through mechanisms beyond weight loss, such as reducing inflammation.
  • Research indicates GLP-1 drugs could ease symptoms of neurodegenerative diseases like Parkinson's and Alzheimer's by reducing brain inflammation and improving mitochondrial function.
  • Studies are exploring the use of GLP-1 medications for various conditions, including depression, anxiety, and even fertility issues, highlighting the broad impact of these drugs.

Semaglutide Therapy for Alcohol Reduction (STAR)

NCT06015893RecruitingPhase 2
National Institute on Drug Abuse (NIDA)
Posted 10/17/2023

INTER-EWING-1 Trial Launches, Offering New Hope for Ewing Sarcoma Patients of All Ages

  • The INTER-EWING-1 trial, a new initiative, aims to improve outcomes for patients of all ages diagnosed with Ewing sarcoma.
  • This trial will assess novel treatment combinations and strategies to combat this aggressive cancer, addressing a critical unmet need.
  • The study's inclusive design ensures that adolescents and young adults, often underrepresented in clinical trials, have access to cutting-edge therapies.
  • Researchers hope the trial will pave the way for more effective, personalized treatment approaches, ultimately improving survival rates and quality of life.

Phaxiam Therapeutics Advances Phage Therapy for Resistant Bacterial Infections

• Phaxiam Therapeutics is focused on developing phage therapies for severe, resistant bacterial infections, particularly Prosthetic Joint Infections (PJI). • The company anticipates filing an Investigational New Drug (IND) application in the U.S. and a Clinical Trial Application (CTA) in Europe for its GLORIA Phase II study in Q4 2024. • Phaxiam's GLORIA study, expected to launch in Q1 2025, will evaluate phage therapy for Staphylococcus aureus infections in PJI patients. • Preliminary data from the PhagoDAIR pilot study are expected by the end of 2024, with complementary data anticipated in 2025.

IN-REC-SUR-E Technique Shows No Significant Long-Term Benefits in Preterm Neonates

  • A randomized clinical trial followed preterm infants receiving IN-REC-SUR-E or IN-SUR-E techniques to assess long-term outcomes.
  • At 2-year follow-up, no significant differences were found in death or major disability between the two groups.
  • Neurodevelopmental outcomes, growth measurements, and respiratory infection rates were similar in both groups.
  • The study suggests IN-REC-SUR-E is a safe method, but further research is needed to confirm long-term benefits.

Semaglutide Shows Promise in Reducing Opioid Overdose Risk in Type 2 Diabetes Patients

  • A recent study suggests semaglutide, used for type 2 diabetes and weight loss, may significantly reduce the risk of opioid overdose in patients with both conditions.
  • The study compared semaglutide to other antidiabetic medications, finding a 42% to 68% lower overdose risk in the semaglutide group over a one-year follow-up.
  • Researchers emphasize the need for further randomized clinical trials to validate these findings and explore the mechanisms behind semaglutide's potential benefits.
  • The findings suggest semaglutide could be a valuable alternative treatment for opioid use disorder, especially in patients with comorbid type 2 diabetes.

GLP-1 Agonists Show Promise in Reducing Opioid Overdose and Alcohol Intoxication

  • A recent study suggests that GLP-1 receptor agonists like semaglutide and tirzepatide may reduce the risk of opioid overdose and alcohol intoxication.
  • Analysis of over a million patient records revealed a 40% lower rate of opioid overdose and a 50% reduction in alcohol intoxication among those taking GLP-1 agonists.
  • Researchers propose that GLP-1 drugs may modulate reward-response pathways in the brain, impacting addictive behaviors.
  • Further clinical trials are needed to confirm these findings and explore the potential of GLP-1 agonists in treating substance use disorders.

Cathepsin C Inhibitor BI 1291583 Shows Promise in Reducing Bronchiectasis Exacerbations

  • Phase 2 AIRLEAF trial results indicate that BI 1291583, a cathepsin C inhibitor, reduces the risk of pulmonary exacerbations in adults with bronchiectasis.
  • The study showed a dose-dependent benefit of BI 1291583 compared to placebo in time to first pulmonary exacerbation over 48 weeks.
  • A 29% decreased risk of initial pulmonary exacerbation was observed with the 5 mg dose of BI 1291583 compared to placebo, though statistical significance was not reached.
  • A phase 3 trial (AIRTIVITY) is planned for 2025 to further evaluate BI 1291583 in bronchiectasis patients.

A Study to Test Whether Different Doses of BI 1291583 Help People With Bronchiectasis

NCT05238675CompletedPhase 2
Boehringer Ingelheim
Posted 4/28/2022

FDA Advisory Committee Recommends Against Checkpoint Inhibitors for Certain Gastroesophageal Cancers

  • The ODAC voted against the risk-benefit profile of PD-1 inhibitors for first-line treatment of HER2-negative, MSS gastric/GEJ adenocarcinoma with PD-L1 expression under 1.
  • Similar concerns were raised regarding esophageal squamous cell carcinoma, with the committee voting against anti-PD-1 therapies in patients with PD-L1 expression less than 1.
  • The decisions were based on data from trials like CheckMate 649, KEYNOTE-859, and RATIONALE-305, which suggested limited benefit in PD-L1-low subgroups.
  • The committee emphasized the need for consistent treatment strategies and acknowledged the challenges of PD-L1 testing variability and interpretation.

First-line Esophageal Carcinoma Study With Pembrolizumab Plus Chemo vs. Chemo (MK-3475-590/KEYNOTE-590)

NCT03189719CompletedPhase 3
Merck Sharp & Dohme LLC
Posted 7/25/2017

A Study of Tislelizumab (BGB-A317) Versus Chemotherapy as Second Line Treatment in Participants With Advanced Esophageal Squamous Cell Carcinoma

NCT03430843CompletedPhase 3
BeiGene
Posted 1/26/2018

A Study of Tislelizumab (BGB-A317) in Combination With Chemotherapy as First Line Treatment in Participants With Advanced Esophageal Squamous Cell Carcinoma

NCT03783442CompletedPhase 3
BeiGene
Posted 12/11/2018

Efficacy Study of Nivolumab Plus Ipilimumab or Nivolumab Plus Chemotherapy Against Chemotherapy in Stomach Cancer or Stomach/Esophagus Junction Cancer

NCT02872116CompletedPhase 3
Bristol-Myers Squibb
Posted 10/12/2016

Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Participants Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-859/KEYNOTE-859)

NCT03675737CompletedPhase 3
Merck Sharp & Dohme LLC
Posted 11/8/2018

A Study to Evaluate Efficacy in Subjects With Esophageal Cancer Treated With Nivolumab and Ipilimumab or Nivolumab Combined With Fluorouracil Plus Cisplatin Versus Fluorouracil Plus Cisplatin

NCT03143153CompletedPhase 3
Bristol-Myers Squibb
Posted 6/29/2017

Tislelizumab in Combination With Chemotherapy as First-Line Treatment in Adults With Inoperable, Locally Advanced or Metastatic Gastric, or Gastroesophageal Junction Carcinoma

NCT03777657CompletedPhase 3
BeiGene
Posted 12/13/2018

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