FDA agrees to design of phase 3 trial for choroidal melanoma treatment
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Key takeaways:
- Aura Biosciences has reached an agreement with the FDA for a study design investigating belzupacap sarotalocan for choroidal melanoma.
- The company expects to begin dosing in the fourth quarter of this year.
Aura Biosciences announced that it has received an agreement from the FDA under a special protocol assessment for the design of a phase 3 trial assessing belzupacap sarotalocan, according to a press release.
Belzupacap sarotalocan (bel-sar) is used to treat early-stage choroidal melanoma.
“This written agreement from the FDA is consistent with our regulatory strategy and reaffirms that the design and planned analysis of the CoMpass phase 3 clinical trial, if successful, adequately address the objectives necessary to support a biologics license application submission for bel-sar for the treatment of early-stage [choroidal melanoma (CM)],” Aura president and chief medical officer Jill Hopkins, MD, said in the release. “We are excited with the momentum in the ocular oncology community to participate in what would be the first ever registration-enabling clinical trial for early-stage CM.”
In the phase 3 CoMpass trial, 100 patients will be randomized to receive a high-dose regimen of bel-sar, also known as AU-011, a low-dose regimen of bel-sar or sham control. The study’s primary endpoint is time to tumor progression. Key secondary endpoints include a composite time to event analysis that will compare tumor control and visual acuity of the high-dose bel-sar group with sham when the last patient completes 15 months of follow-up.
Aura expects to dose the first patient in the trial in the fourth quarter of 2023.
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