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    DRUG:

    belzupacap sarotalocan (AU-011)

    i
    Other names: AU-011, AU 011, bel-sar
    Company:
    Aura Biosci
    Drug class:
    Reactive oxygen species stimulant
    Related drugs:
    10d
    Early Efficacy and Exploratory Biomarker Data of Bel-sar in Patients with Intermediate-risk and High-risk Non-muscle-invasive Bladder Cancer. (PubMed, Eur Urol Open Sci)
    Bel-sar (belzupacap sarotalocan) is a first-in-class virus-like drug conjugate composed of a tumor-targeting virus-like particle linked to a photoactivatable dye, inducing proimmunogenic tumor cell death and antitumor immune response...Bel-sar demonstrated focal administration feasibility, a favorable safety profile, and encouraging preliminary efficacy in NMIBC, with robust immune activation in treated and untreated tumors. These findings support bel-sar's continued development as a therapy combining local tumor eradication with durable immune surveillance.
    Journal
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    CD4 (CD4 Molecule)
    |
    belzupacap sarotalocan (AU-011)
    3ms
    Trial to Evaluate the Safety and Feasibility of Belzupacap Sarotalocan (AU-011) for the Treatment of Conjunctival Melanoma, Melanocytic Lesions, or Conjunctival Squamous Cell Carcinoma in adult participants (ACTRN12626000465358)
    P1, N=36, Not yet recruiting, Aura Biosciences, Inc.
    New P1 trial
    |
    belzupacap sarotalocan (AU-011)
    4ms
    Choroidal Melanoma Patient-Reported Outcome Study (CM-PRO) in a Subset of AU-011-301 (CoMpass) Subjects (clinicaltrials.gov)
    P=N/A, N=15, Recruiting, Aura Biosciences
    New trial
    |
    belzupacap sarotalocan (AU-011)
    6ms
    A Long-Term Follow-Up Study of Subjects Completing the AU-011-301(CoMpass) for Early Choroidal Melanoma (clinicaltrials.gov)
    P=N/A, N=100, Not yet recruiting, Aura Biosciences
    New trial
    |
    belzupacap sarotalocan (AU-011)
    6ms
    AU-011-203: Suprachoroidal Administration in Subjects With Metastases to the Choroid (clinicaltrials.gov)
    P2, N=24, Recruiting, Aura Biosciences | Trial completion date: Feb 2027 --> Oct 2027 | Trial primary completion date: Mar 2026 --> Nov 2026
    Trial completion date • Trial primary completion date
    |
    belzupacap sarotalocan (AU-011)
    7ms
    AU-011-102: A Phase 1, Open-label Trial of Belzupacap Sarotalocan (AU-011) in Bladder Cancer (clinicaltrials.gov)
    P1, N=55, Recruiting, Aura Biosciences | Trial primary completion date: Dec 2026 --> Mar 2027
    Trial primary completion date
    |
    belzupacap sarotalocan (AU-011)
    7ms
    CoMpass: 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 (clinicaltrials.gov)
    P3, N=100, Recruiting, Aura Biosciences | Trial completion date: Mar 2027 --> Aug 2028 | Trial primary completion date: Mar 2026 --> Nov 2027
    Trial completion date • Trial primary completion date
    |
    belzupacap sarotalocan (AU-011)
    9ms
    NMIBC: A Phase 1, Open-label Trial of Belzupacap Sarotalocan (AU-011) in Bladder Cancer (clinicaltrials.gov)
    P1, N=55, Recruiting, Aura Biosciences | N=21 --> 55 | Trial completion date: Jul 2024 --> Apr 2027 | Trial primary completion date: Jun 2024 --> Dec 2026
    Enrollment change • Trial completion date • Trial primary completion date
    |
    belzupacap sarotalocan (AU-011)
    9ms
    AU-011-203: Suprachoroidal Administration in Subjects With Metastases to the Choroid (clinicaltrials.gov)
    P2, N=24, Recruiting, Aura Biosciences | Not yet recruiting --> Recruiting
    Enrollment open
    |
    belzupacap sarotalocan (AU-011)
    over1year
    AU-011-203: Suprachoroidal Administration in Subjects With Choroidal Metastasis From Breast or Lung Primary Tumors (clinicaltrials.gov)
    P2, N=24, Not yet recruiting, Aura Biosciences
    New P2 trial
    |
    belzupacap sarotalocan (AU-011)
    almost2years
    Phase 2 Trial to Evaluate Belzupacap Sarotalocan (AU-011) Via Suprachoroidal Administration in Subjects With Primary Indeterminate Lesions and Small Choroidal Melanoma (clinicaltrials.gov)
    P2, N=22, Completed, Aura Biosciences | Active, not recruiting --> Completed | Trial completion date: May 2025 --> Apr 2024
    Trial completion • Trial completion date
    |
    belzupacap sarotalocan (AU-011)
    over2years
    Study in Subjects With Small Primary Choroidal Melanoma (clinicaltrials.gov)
    P1/2, N=57, Completed, Aura Biosciences | Phase classification: P1b/2 --> P1/2
    Phase classification
    |
    belzupacap sarotalocan (AU-011)