NCT06007690 A Phase 3 Randomized, Masked, Controlled Trial to Evaluate Efficacy and Safety of Belzupacap Sarotalocan (AU-011) Treatment Compared to Sham Control in Subjects With Primary Indeterminate Lesions or Small Choroidal Melanoma
| NCT ID | NCT06007690 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Aura Biosciences |
| Condition | Choroidal Melanoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2023-12-06 |
| Primary Completion | 2027-11-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 100 participants in total. It began in 2023-12-06 with a primary completion date of 2027-11-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The primary objective is to determine the safety and efficacy of belzupacap sarotalocan (bel-sar) compared to sham control in patients with primary indeterminate lesions (IL) or small choroidal melanoma (CM).
Eligibility Criteria
Inclusion Criteria: * Clinical diagnosis of primary indeterminate lesion or small choroidal melanoma (IL/CM) * Have no evidence of metastatic disease confirmed by imaging * Be treatment naive for IL/CM (subjects who received PDT may be eligible) Exclusion Criteria: * Have known contraindications or sensitivities to the study drug or laser * Active ocular infection or disease
Contact & Investigator
Medical Monitor
STUDY DIRECTOR
Aura Biosciences
Frequently Asked Questions
Who can join the NCT06007690 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Choroidal Melanoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06007690 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 100 participants.
Is NCT06007690 currently recruiting?
Yes, NCT06007690 is actively recruiting participants. Contact the research team at clinical@aurabiosciences.com for enrollment information.
Where is the NCT06007690 trial being conducted?
This trial is being conducted at Birmingham, United States, La Jolla, United States, Los Angeles, United States, Palo Alto, United States and 11 additional locations.
Who is sponsoring the NCT06007690 clinical trial?
NCT06007690 is sponsored by Aura Biosciences. The principal investigator is Medical Monitor at Aura Biosciences. The trial plans to enroll 100 participants.
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