Avid Bioservices Inc (CDMO)

[terrygd]

Can someone explain to me why we are doing Phase I at NABTT?

Dear Kimberly
While looking over your current protocols on the NABTT site, I noticed that the following had no description of what Phase it will be . Will this be a Phase I, II, or III trial? What is a dose confirmation study? Phase I? Thank you for any assistance.

Respectfully,

Terry

Protocols In Development *(Expanded Information Not Available)

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An Open-label, Dose Confirmation and Dosimetry Study of Interstitial ^131 I-chTNT-1/B MAb (COTARA^TM ) For the Treatment of Glioblastoma Multiforme (GBM) at 1^st Relapse

REPLY

Protocol Development Coordinator
NABTT Central Office
Phone: [phone]
Fax: [phone]

Terry,

You are correct. A dose confirmation study is a Phase I study. The objective of this study is to find the safe dose for this drug.

Thanks,