Clinical Trials
The GW Medical Faculty Associates is proud of its physician scientists and their commitment to medical research. These clinical studies are designed to add to the medical knowledge base and relate to the treatment, diagnosis, and prevention of diseases or conditions.
Lamprene (Clofazimine) is approved by FDA for the treatment of leprosy. It is no longer available through pharmacies in the US. It is being tested in non-Novartis clinical studies for drug resistant tuberculosis and non-tuberculous mycobacteria (NTM).
ICoN-1 is a research study that evaluates the efficacy and safety of Clofazimine Inhalation Suspension on top of guideline-based therapy (GBT).
In this study, we hope to better understand how the bacteria living in your nose (called the nasal microbiome) interacts with the local immune system, and also how those may impact the immune response to live-attenuated influenza vaccine (LAIV) (e.g., nasal spray flu vaccine).
Phase 1 Study of Intratumoral Administration of VAX014 in Subjects With Advanced Solid Tumors
Primary Outcome Measure:
• Progression-Free Survival (PFS)
o Time Frame: Up to 6 years 6 months
Primary Outcome Measure:
• To assess the safety and tolerability of tucatinib in combination with eribulin and trastuzumab in patients with unresectable or recurrent metastatic HER2+ breast cancer who have had prior treatment with trastuzumab, and trastuzumab deruxtecan.
• Evaluate the relative toxicity/tolerability of these therapeutic agents when used in combination in this…
This is an open-label, non-randomized, multicenter, dose-escalation and expansion study in patients with selected solid tumors.
This Phase III Trial evaluates whether breast conservation surgery and endocrine therapy results in a non-inferior rate of invasive or non-invasive ipsilateral breast tumor recurrence (IBTR) compared to breast conservation with breast radiation and endocrine therapy.
This is a Phase 1b/2, Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combinations In Patients With Metastatic Breast Cancer.
We are trying to learn more about if the gut microbiome (the microbes that live in our digestive tract) of individuals with eAD, MCI, and healthy controls are altered following lifestyle changes.
An experimental hookworm infection model is being developed to provide early proof-of-concept that a hookworm vaccine targeting the blood-feeding pathway of adult hookworms is feasible and efficacious.
Primary Outcome Measures:
Determination of Overall survival (OS) [Time Frame: Until trial end, death, withdrawal of consent or lost to follow-up, assessed up to 60 months]
Determination of the Optimal Biological Dose (OBD) [Time Frame: Up to 15 months]
Frequency of adverse events (AEs) [Time Frame: Up to 15 months]
Severity of adverse events (AEs) [Time Frame: Up to 15…
Primary Outcome Measures:
Phase 1: Nature, incidence, relatedness, and severity of all AEs and SAEs according to the CTCAE v5.0. [Time Frame: Approximately 2 years]
The type, incidence, relatedness and severity of treatment emergent adverse events of EG-70 as assessed by NCI-CTCAE V5.0 will be monitored.
Phase 2: Percentage of patients with cystoscopic CR at 48 weeks, based on…
This is a phase 3 open label, multi-center, randomized, active-controlled non-inferiority trial that compares the safety and effectiveness of a 6-week regimen of daily rifapentine against the current standard of 12-16 weeks of rifamycin-based treatment for latent TB infection (LTBI).
The primary goal of this study is to assess the safety and tolerability of mRNA-4359 administered alone and in combination with pembrolizumab.