Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

The AMPLIFY, a non-randomised, single-arm, open-label, multi-centre, Phase III registrational trial of 64Cu-SAR-bisPSMA in patients with BCR of PC

Next Previous
Search
Trial Profile

The AMPLIFY, a non-randomised, single-arm, open-label, multi-centre, Phase III registrational trial of 64Cu-SAR-bisPSMA in patients with BCR of PC

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 15 Oct 2024

Price :
$35 *
Note:
  • Adis is an information provider.
  • Final gross price and currency may vary according to local VAT and billing address.
  • Your purchase entitles you to full access to the information contained in our trial profile at the time of purchase.
  • A link to download a PDF version of the trial profile will be included in your email receipt.

At a glance

  • Drugs 64Cu SAR bisPSMA-Clarity Pharmaceuticals (Primary)
  • Indications Prostate cancer
  • Focus Diagnostic use; Registrational
  • Acronyms AMPLIFY
  • Sponsors Clarity Pharmaceuticals

    • Most Recent Events

    • 14 Oct 2024 According to a Clarity Pharmaceuticals media release, the United States Food and Drug Administration (U.S. FDA) provided positive feedback on a pivotal Phase III trial for 64Cu-SAR-bisPSMA diagnostic in prostate cancer patients with biochemical recurrence (BCR). As a pivotal trial, the final study results are intended to provide sufficient evidence to support an application to the FDA for approval of 64Cu-SAR-bisPSMA as a new diagnostic imaging agent in prostate cancer.
    • 14 Oct 2024 According to a Clarity Pharmaceuticals media release, the positive results of the completed COBRA and PROPELLER trials, including the significantly higher uptake and retention in lesions compared to standard-of-care (SOC) imaging, as well as the substantial increase in the number of lesions detected with next-day imaging compared to same-day imaging, formed the data package to guide the design of the AMPLIFY trial. Patient recruitment for the AMPLIFY trial is expected to commence in early 2025.
    • 22 Aug 2024 According to a Clarity Pharmaceuticals media release, company is preparing for an End of Phase meeting with the FDA for a second pivotal Phase III trial.

You need to be a logged in or subscribed to view this content Request demo

If your organization or you do not have a subscription, try one of the following:
  • Contacting your organization’s admin about adding this content to your AdisInsight subscription
  • Buying a PDF version of any individual profile
  • Request a free trial
If your organization has a subscription, there are several access options, even while working remotely:
  • Working within your organization’s network
  • with username/password or try to via your institution
  • Persisted access using your organization’s identifier stored in your user browser for 90 days
Back to top