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July 14, 2016updated 13 Jul 2022 10:13am

US FDA approves patient enrolment in Phase I/II study of Nivolumab with Plinabulin

The UC San Diego Moores Cancer Centre has secured a US FDA clearance to enrol patients with metastatic, non-small-cell lung cancer (NSCLC) for the Phase I/II study of Nivolumab in combination with Plinabulin.

The UC San Diego Moores Cancer Centre has secured a US FDA clearance to enrol patients with metastatic, non-small-cell lung cancer (NSCLC) for the Phase I/II study of Nivolumab in combination with Plinabulin.

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Dr. Bazhenova of the UC San Diego Moores Cancer Centre sought approval for an investigator-sponsored, investigational new drug application (IND) on 23 May.

Plinabulin is a Phase III, immuno-oncology compound of clinical stage biopharmaceutical company BeyondSpring Pharmaceuticals, which is focused on the development of innovative cancer therapies.

BeyondSpring co-founder, chairman and CEO Dr. Lan Huang said: "This clinical trial provides further opportunity to assess the mechanism of Plinabulin in a combination treatment, while collecting much-needed information about the safety and preliminary efficacy profile of the combination."

"The granting of this clearance to begin enrolling patients is an exciting next step for the development of Plinabulin."

The study aims to ascertain the maximum tolerated dose and / or recommended Phase II dose of Plinabulin in combination with Nivolumab for patients suffering with with metastatic NSCLC.

Plinabulin is a small molecule, immuno-oncology agent that activates dendritic cell maturation, induces tumour antigen specific T-cell activation and down-regulates Treg.

Nivolumab is a programmed cell-death-1 (PD-1) inhibitor that has activity in NSCLC, compared to standard of care.

Dr. Bazhenova said: "The granting of this clearance to begin enrolling patients is an exciting next step for the development of Plinabulin.

"We anticipate that the combination study may lead to additional synergistic efficacy with Nivolumab and a well-tolerated safety profile."

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Direct-to-Patient Trials: How IRT Plays an Important Role in Bellerophon's Direct-to-Patient Trials

As the industry strengthens its focus on patient centricity, Direct-to-Patient clinical trials have emerged as a popular trial design that have the potential to increase patient recruitment and retention. IRT plays a crucial role in the success of a Direct-to-Patient trial. Because drug supplies are being managed and shipped from distribution facilities directly to patients’ homes, a sponsor must have a high-quality system in place to accurately track the chain of custody, ensure patient-blinding and handle other logistical challenges. What You Will Learn Benefits and challenges associated with the Direct-to-Patient model Bellerophon's top considerations when implementing this trial design How IRT can equip study teams to successfully track chain of custody, ensure patient blinding, and handle logistical challenges
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Enter your details here to receive your free Case Study.

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