NCT04417530 is a Phase 2 clinical trial of AU-011 in Uveal Melanoma, sponsored by Aura Biosciences.

Who is sponsoring NCT04417530?

NCT04417530 is sponsored by Aura Biosciences.

What drugs are being tested in NCT04417530?

Interventions in NCT04417530: AU-011, Suprachoroidal Microinjector, PDT Laser.

What condition does NCT04417530 study?

NCT04417530 studies Uveal Melanoma, Ocular Melanoma, Choroidal Melanoma.

Is NCT04417530 still recruiting?

NCT04417530 is currently completed. Last updated 3 March 2025.

Last reviewed 2025-03-03 · How we verify

NCT04417530

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Phase 2 Trial to Evaluate Belzupacap Sarotalocan (AU-011) Via Suprachoroidal Administration in Subjects With Primary Indeterminate Lesions and Small Choroidal Melanoma

Completed Phase 2 Last updated 3 March 2025

What this trial tests

Phase 2 trial testing AU-011 in Uveal Melanoma in 22 participants. Completed in 22 April 2024.

Timeline

5 August 2020

Primary endpoint
22 April 2024

22 April 2024

Quick facts

Lead sponsor	Aura Biosciences
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	22
Start date	5 August 2020
Primary completion	22 April 2024
Estimated completion	22 April 2024
Sites	22 locations across United States

Drugs / interventions tested

AU-011 — full drug profile →
Suprachoroidal Microinjector
PDT Laser

Conditions studied

Uveal Melanoma — all drugs for Uveal Melanoma →
Ocular Melanoma — all drugs for Ocular Melanoma →
Choroidal Melanoma — all drugs for Choroidal Melanoma →

Sponsor

Aura Biosciences — full company profile →

Who can join

18 and older, any sex, with Uveal Melanoma or Ocular Melanoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The primary objective is to determine the safety, tolerability, and preliminary efficacy of belzupacap sarotalocan for the treatment of primary indeterminate lesions and small choroidal melanoma (IL/CM).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

New Therapeutic Perspectives in the Treatment of Uveal Melanoma: A Systematic Review.
Toro MD, Gozzo L, Tracia L, Cicciù M, et al · · 2021 · cited 26× · PMID 34680428 · DOI 10.3390/biomedicines9101311
Virus-Like Particle-Drug Conjugates Induce Protective, Long-lasting Adaptive Antitumor Immunity in the Absence of Specifically Targeted Tumor Antigens.
Kines RC, Thompson CD, Spring S, Li Z, et al · · 2021 · cited 25× · PMID 33853825 · DOI 10.1158/2326-6066.cir-19-0974
Immune checkpoint inhibition combined with targeted therapy using a novel virus-like drug conjugate induces complete responses in a murine model of local and distant tumors.
Huis In 't Veld RV, Ma S, Kines RC, Savinainen A, et al · · 2023 · cited 15× · PMID 36997666 · DOI 10.1007/s00262-023-03425-3
Recent Advances in Molecular and Genetic Research on Uveal Melanoma.
Fuentes-Rodriguez A, Mitchell A, Guérin SL, Landreville S. · · 2024 · cited 13× · PMID 38920653 · DOI 10.3390/cells13121023
Triamcinolone acetonide injectable suspension for suprachoroidal use in the treatment of macular edema associated with uveitis.
Thomas J, Kim L, Albini T, Yeh S. · · 2022 · cited 11× · PMID 36060305 · DOI 10.1080/17469899.2022.2114456
What's New in Ocular Drug Delivery: Advances in Suprachoroidal Injection since 2023.
Wu KY, Gao A, Giunta M, Tran SD. · · 2024 · cited 10× · PMID 39204112 · DOI 10.3390/ph17081007
Harnessing Human Papillomavirus' Natural Tropism to Target Tumors.
Kines RC, Schiller JT. · · 2022 · cited 9× · PMID 36016277 · DOI 10.3390/v14081656
From Molecular Biology to Novel Immunotherapies and Nanomedicine in Uveal Melanoma.
Synoradzki KJ, Paduszyńska N, Solnik M, Toro MD, et al · · 2024 · cited 7× · PMID 38392052 · DOI 10.3390/curroncol31020058

Verify or expand the search:

Other trials of AU-011

Trials testing the same drug.

NCT06643884 — Suprachoroidal Administration in Subjects With Metastases to the Choroid · Phase 2 · recruiting
NCT05266430 — Prospective Group-Matched Study With Belzupacap Sarotalocan (Bel-sar; AU-011) or Plaque Radiotherapy for Primary Indeter · terminated

Other recruiting trials for Uveal Melanoma

Currently open trials in the same condition.

NCT07421739 — Choroidal Melanoma Patient-Reported Outcome Study (CM-PRO) in a Subset of AU-011-301 (CoMpass) Subjects · recruiting
NCT06070012 — Tebentafusp in HLA-A*0201 Positive Previously Untreated Metastatic Uveal Melanoma · Phase 2 · recruiting
NCT06932757 — Adjuvant Quisinostat in High-Risk Uveal Melanoma · Phase 2 · recruiting
NCT06805825 — A Study of the c-Kit Specific Antibody-Drug Conjugate NN3201 for Advanced and/or Metastatic Solid Tumors Known to Expres · Phase 1 · recruiting
NCT06519266 — PHP in Combination With IPI1/NIVO3 Compared to IPI3/NIVO1 Only in Patients With Uveal Melanoma Liver Metastases · Phase 3 · recruiting

Other Aura Biosciences trials

Trials by the same sponsor.

NCT07338968 — A Long-Term Follow-Up Study of Subjects Completing the AU-011-301(CoMpass) for Early Choroidal Melanoma · not yet recruiting
NCT07421739 — Choroidal Melanoma Patient-Reported Outcome Study (CM-PRO) in a Subset of AU-011-301 (CoMpass) Subjects · recruiting
NCT06643884 — Suprachoroidal Administration in Subjects With Metastases to the Choroid · Phase 2 · recruiting
NCT06007690 — A Phase 3 Randomized, Masked, Controlled Trial to Evaluate Efficacy and Safety of Belzupacap Sarotalocan (AU-011) Treatm · Phase 3 · recruiting
NCT05266430 — Prospective Group-Matched Study With Belzupacap Sarotalocan (Bel-sar; AU-011) or Plaque Radiotherapy for Primary Indeter · terminated

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04417530 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 21 May 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Aura Biosciences
Last refreshed: 3 March 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04417530.