A Phase 1, Open-label Trial of Belzupacap Sarotalocan (AU-011) in Bladder Cancer

Conditions

• NMIBC
• Non-Muscle Invasive Bladder Carcinoma
• Non-Muscle Invasive Bladder Neoplasms
• Non-Muscle Invasive Bladder Urothelial Carcinoma
• Non-muscle-invasive Bladder Cancer
• Urothelial Carcinoma Bladder

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• AU-011 — DRUG
  Administration of AU-011 intratumorally and intramurally
• AU-011 in Combination with Medical Laser Adminstration — COMBINATION_PRODUCT
  AU-011 Intratumorally and Intramurally
• AU-011 in Combination with Medical Laser Administration — COMBINATION_PRODUCT
  AU-011 Intratumorally

Study Details

The main objectives of this study are to determine the feasibility and safety of Belzupacap Sarotalocan (AU-011, bel-sar) treatment of bladder cancer utilizing focal injections with or without laser application.

Key Dates

Start date

Sep 26, 2022

Status verified

Apr 2026

Primary completion

Mar 31, 2027

Completion

Mar 31, 2027

Study Design

Enrollment

55 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Focal injections of AU-011 prior to TURBT (1b)
  Intratumoral (50 μg) and intramural (50 μg) injection of AU-011 prior to the standard of care (TURBT) in patients with NMIBC.
• Experimental: Focal injections of AU-011 with laser application before TURBT (4a)
  Intratumoral (50 μg) and intramural (50 μg) injection of AU-011 with laser application before standard of care (TURBT) in patients with NMIBC.
• Experimental: Focal injection of AU-011 with laser application before TURBT (4b)
  Focal injection of AU-011 (100 μg) with laser application before standard of care (TURBT) in patients with NMIBC.
• Experimental: Focal injection of AU-011 with laser application before TURBT (4c)
  Focal injection of AU-011 (200 μg) with laser application before standard of care (TURBT) in patients with NMIBC.
• Experimental: Focal injection of AU-011 and laser application with option for TURBT (4d)
  Participants with intermediate-risk NMIBC will receive multiple treatment cycles of focal AU-011 (200 ug per lesion) with laser treatment and option for TURBT in patients with intermediate risk NMIBC. Participants will be evaluated for safety and response to AU-011 up to 12 months from initiation of treatment.
• Experimental: Focal injection of AU-011 and laser application with option for TURBT (4e)
  Participants with intermediate-risk NMIBC will receive multiple treatment cycles of focal AU-011 (400 µg per lesion) followed by laser activation, with the option for TURBT. Participants will be evaluated for safety and response to AU-011 for up to 12 months from initiation of treatment. Enrollment will occur in parallel with Cohort 4g, with randomized (1:1) assignment.
• Experimental: Focal injection of AU-011 and laser application with mandatory TURBT (4f)
  Participants with high-risk NMIBC will receive multiple treatment cycles of focal AU-011 (400 µg per lesion) followed by laser activation prior to mandatory TURBT. Participants will be evaluated for safety and response to AU-011 for up to 12 months from initiation of treatment.
• Experimental: Focal injection of AU-011 and laser application with optional TURBT (4g)
  Participants with intermediate-risk NMIBC will receive multiple treatment cycles of focal AU-011 (400 µg per lesion) followed by laser activation with the option of TURBT. Participants will be evaluated for safety and response to AU-011 for up to 12 months from initiation of treatment. Enrollment will occur in parallel with Cohort 4e, with randomized (1:1) assignment.
• Experimental: Focal injection of AU-011 and laser application with option for TURBT (4h)
  Participants with intermediate-risk NMIBC will receive multiple treatment cycles of focal AU-011 (800 ug per lesion) with laser treatment and option for TURBT. Participants will be evaluated for safety and response to AU-011 up to 12 months from initiation of treatment. This arm is optional and will be run at the discretion of the sponsor.
• Experimental: Focal injection of AU-011 and laser application with mandatory TURBT (4i)
  Participants with high-risk NMIBC will receive multiple treatment cycles of focal AU-011 (800 µg per lesion) before mandatory TURBT. Participants will be evaluated for safety and response to AU-011 up to 12 months from initiation of treatment. This arm is optional and will be run at the discretion of the sponsor.

Primary Outcome Measure

Safety of AU-011: Incidences of SAEs and DLTs [ Time Frame: up to 12 months ]

Central Contacts

• Medical Monitor
  617-500-8864
  [email protected]

Locations (11)

Find similar trials in Little Rock, AR

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