AgentĪ monoclonal antibody donated by Janssen Biotech, Inc., that inhibits tumor necrosis factor, a pro-inflammatory cytokine hypothesized to drive the excess inflammatory response some experience during advanced stages of COVID-19. The different treatments will be assessed with respect to illness severity, recovery speed, mortality and hospital resource utilization. It will evaluate the safety and efficacy of at least three immune modulators when given as an add-on therapy to remdesivir, an antiviral approved for treatment of COVID-19, and the standard of care in use at local clinics.
#GROOVE AGENT 4 TRIAL TRIAL#
This Phase 3 trial will enroll hospitalized adults with moderate to severe COVID-19 disease. The ACTIV-1 master protocol will test promising immune modulator compounds, a class of drugs that help minimize the deleterious effects of an overactive immune response to SARS-CoV-2 infection. As studies of specific compounds are launched, NIH will list those studies under each protocol.
The ACTIV master protocols are listed below. Adaptive master protocols reduce administrative burden and cost, provide a flexible framework to rapidly identify drugs that work, and rapidly move additional experimental agents into the trial. Adaptive protocols swiftly weed out experimental drugs that do not demonstrate effectiveness and identify those that do. Master protocols allow coordinated and efficient evaluation of multiple investigational agents as they become available, but within the same clinical trial structure, across multiple study sites. Working in an unprecedented timeframe, the ACTIV public-private partnership has evaluated hundreds of available therapeutic agents with potential application for COVID-19, prioritized the most promising candidates, designed and harmonized adaptive master protocols for ACTIV clinical trials, and selected numerous NIH-supported networks to launch these clinical trials to test prioritized therapeutic candidates (see the summary of agents under study). Further exploration of DNA minor groove-binding agents in the treatment of HCC appears warranted.Summary of Therapeutic Agents ACTIV Clinical Trials Still Recruiting However, because of significant and prolonged hematologic toxicity, when given as a single dose every 6 weeks, further development of this drug in HCC is not possible. KW-2189 showed evidence of anti-tumor activity in HCC. Two responses were seen in patients enrolled at the higher dose, including one sustained CR. Due to continued significant hematologic toxicity in the next five patients enrolled at the lower dose the trial was closed to accrual. Other endpoints included toxicity, disease-free survival, and overall survival.ĭue to hematologic toxicity the dose of KW-2189 was reduced to 0.375 mg/m2 after 11 patients had been enrolled into the trial. The primary endpoint of the trial was objective regression. Patients received KW-2189 at a dose of 0.5 mg/m2 administered on day 1 of a 6-week cycle. KW-2189, a DNA minor groove-binding agent, has shown promising activity against HCC in preclinical evaluations.Ī phase II study was conducted to evaluate the activity of KW-2189 in patients with histologic or cytologic confirmed advanced or metastatic HCC who had no prior systemic therapy. Currently no effective therapies exist for patients with advanced or metastatic HCC. Hepatocellular carcinoma (HCC) is a common cancer in certain portions of the world.
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