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

Primary Purpose

Non-muscle-invasive Bladder Cancer

Status

Recruiting

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

AU-011

AU-011 in Combination with Medical Laser

About this trial

This is an interventional treatment trial for Non-muscle-invasive Bladder Cancer focused on measuring NMIBC, Cystectomy, TURBT, Intramural, AU-011, Belzupacap Sarotalocan, Intratumoral

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Have NMIBC with urothelial carcinoma confirmed by histopathology (note: if recurrent lesion, previous tumor biopsy is acceptable). Biopsy or pathology must be obtained within 6 months prior to screening
Have no evidence of metastatic disease
Have a normal upper urinary tract
Adequate bone marrow, renal, and hepatic function

Exclusion Criteria:

Current or history of muscle invasive (i.e., T2 or higher) bladder cancer per AUA guideline or metastatic urothelial carcinoma.
Any additional malignancy that requires treatment. Exceptions include:
1. Basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy with evidence of remission for at least 1 year.
2. In situ cervical cancer treated and with at least 1 year without recurrence.
3. Localized prostate cancer under active care that was treated with definitive therapy (surgically or through radiation therapy) is acceptable, provided that the following criteria are met:
  - Stage T2N0M0 or lower; prostate-specific antigen (PSA) undetectable for 2 years while off androgen deprivation therapy or no more than 2 consecutive rising PSAs.
  - Tumors can be low or intermediate risk prostate cancer under active surveillance.
  - Any significant illness or clinically significant laboratory abnormalities that the Investigator determines could interfere with trial participation or put the subject at any unnecessary risk.
Used an investigational drug or medical device within 30 days or 5 half-lives (whichever is longer) of Visit 1 or be concurrently enrolled in another investigational trial.
Active bacterial, fungal, or viral infections - all prior infections must have resolved following optimal therapy and subject must be off all systemic anti-infective agents.
Chronic active hepatitis B or C.

Sites / Locations

Carolina Urologic Research CenterRecruiting
Urology Associates, P.C.Recruiting
Mary Crowley Cancer ResearchRecruiting
Baylor College of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

AU-011 Intramurally with or without Intratumoral Injection prior to TURBT or Cystectomy

Intramural AU-011 with Laser Application prior to TURBT

Intramural AU-011 with Laser Application prior to Cystectomy

Intermural and Intratumoral AU-011 with Laser Application prior to TURBT

Arm Description

Administration of AU-011 alone intramurally with or without intratumoral administration prior to the standard of care procedure (cystectomy or TURBT)

AU-011 intramural administration with laser application prior to the standard of care TURBT

AU-011 intramural administration with laser application prior to standard of care Cystectomy

AU-011 intramural and intratumoral administration with laser application prior to standard of care TURBT

Outcomes

Primary Outcome Measures

Safety of AU-011: Incidences of SAEs and DLTs

Incidence and severity of treatment-related adverse events and serious adverse events (SAEs) and incidence of dose-limiting toxicities (DLTs).

Secondary Outcome Measures

Distribution of AU-011

Lateral distribution of AU-011 using immunohistochemical staining (distance measured by pathological sample in millimeters and overall area measured in millimeters squared).

Area of Necrosis of Bladder Tumor

Area of necrosis in bladder tumor base, based on histopathology samples in Cohorts 2, 3, and 4 (distance of necrosis measured by pathological sample in millimeters and overall area measured in millimeters squared).

Degree of Necrosis of Bladder Tumor

Degree of necrosis in bladder tumor base, based on histopathology samples in Cohorts 2, 3 and 4 (degree of necrosis to be estimated by a customized relative scale ranging from +1 to +4 based on Pathologist review).

Percent of Participants receiving a complete dose of bel-sar intramurally/intratumorally

Full 100 μg dose being successfully injected without issue

Procedure Feasibility

Evaluation of the percent of successful injections, adverse events and DLTs.

Evidence of Immune Response

Immune cell infiltration on histology in Cohorts 2, 3 and 4 using immune markers.

Full Information

NCT ID

NCT05483868

First Posted

July 20, 2022

Last Updated

May 30, 2023

Sponsor

Aura Biosciences

1. Study Identification

Unique Protocol Identification Number

NCT05483868

Brief Title

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

Official Title

A Phase 1, Open-label Trial of Belzupacap Sarotalocan (AU-011) to Determine the Feasibility and Safety of Intramural Injection With or Without Intratumoral Injection in Subjects With Non-muscle Invasive Bladder Cancer (NMIBC)

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

September 26, 2022 (Actual)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Aura Biosciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

The main objectives of this study are i) to evaluate the incidence of AU-011 treatment-related adverse events, serious adverse events (SAEs) and dose-limiting toxicities (DLTs) and ii) to determine the feasibility of AU-011 treatment of non-muscle invasive bladder cancer utilizing intramural with or without intratumoral injection.

Detailed Description

Aura is conducting a Phase 1, 'window of opportunity', open-label trial of belzupacap sarotalocan (AU-011) to determine the feasibility and safety of intramural injection with or without intratumoral injection in subjects with non-muscle invasive bladder cancer (NMIBC). This study will evaluate distribution of AU-011 using immunohistochemical staining, area and degree of necrosis in bladder tumor base and evidence of an immune response.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-muscle-invasive Bladder Cancer

Keywords

NMIBC, Cystectomy, TURBT, Intramural, AU-011, Belzupacap Sarotalocan, Intratumoral

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

23 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

AU-011 Intramurally with or without Intratumoral Injection prior to TURBT or Cystectomy

Arm Type

Experimental

Arm Description

Administration of AU-011 alone intramurally with or without intratumoral administration prior to the standard of care procedure (cystectomy or TURBT)

Arm Title

Intramural AU-011 with Laser Application prior to TURBT

Arm Type

Experimental

Arm Description

AU-011 intramural administration with laser application prior to the standard of care TURBT

Arm Title

Intramural AU-011 with Laser Application prior to Cystectomy

Arm Type

Experimental

Arm Description

AU-011 intramural administration with laser application prior to standard of care Cystectomy

Arm Title

Intermural and Intratumoral AU-011 with Laser Application prior to TURBT

Arm Type

Experimental

Arm Description

AU-011 intramural and intratumoral administration with laser application prior to standard of care TURBT

Intervention Type

Drug

Intervention Name(s)

AU-011

Intervention Description

Administration of AU-011 intramurally or intramurally and intratumorally

Intervention Type

Combination Product

Intervention Name(s)

AU-011 in Combination with Medical Laser

Intervention Description

Administration of AU-011 intramurally or intramurally and intratumorally with Laser application.

Primary Outcome Measure Information:

Title

Safety of AU-011: Incidences of SAEs and DLTs

Description

Incidence and severity of treatment-related adverse events and serious adverse events (SAEs) and incidence of dose-limiting toxicities (DLTs).

Time Frame

56 days

Secondary Outcome Measure Information:

Title

Distribution of AU-011

Description

Lateral distribution of AU-011 using immunohistochemical staining (distance measured by pathological sample in millimeters and overall area measured in millimeters squared).

Time Frame

9 days

Title

Area of Necrosis of Bladder Tumor

Description

Time Frame

9 days

Title

Degree of Necrosis of Bladder Tumor

Description

Time Frame

9 days

Title

Percent of Participants receiving a complete dose of bel-sar intramurally/intratumorally

Description

Full 100 μg dose being successfully injected without issue

Time Frame

1 day

Title

Procedure Feasibility

Description

Evaluation of the percent of successful injections, adverse events and DLTs.

Time Frame

1 Day

Title

Evidence of Immune Response

Description

Immune cell infiltration on histology in Cohorts 2, 3 and 4 using immune markers.

Time Frame

9 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Have NMIBC with urothelial carcinoma confirmed by histopathology (note: if recurrent lesion, previous tumor biopsy is acceptable). Biopsy or pathology must be obtained within 6 months prior to enrollment Have no evidence of metastatic disease Have a normal upper urinary tract Adequate bone marrow, renal, and hepatic function Exclusion Criteria: Current or history of muscle invasive (i.e., T2 or higher) bladder cancer per AUA guideline or metastatic urothelial carcinoma. Any additional malignancy that requires treatment. Exceptions include: Basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy with evidence of remission for at least 1 year. In situ cervical cancer treated and with at least 1 year without recurrence. Localized prostate cancer under active care that was treated with definitive therapy (surgically or through radiation therapy) is acceptable, provided that the following criteria are met: Stage T2N0M0 or lower; prostate-specific antigen (PSA) undetectable for 2 years while off androgen deprivation therapy or no more than 2 consecutive rising PSAs. Tumors can be low or intermediate risk prostate cancer under active surveillance. Any significant illness or clinically significant laboratory abnormalities that the Investigator determines could interfere with trial participation or put the subject at any unnecessary risk. Used an investigational drug or medical device within 30 days or 5 half-lives (whichever is longer) of Visit 1 or be concurrently enrolled in another investigational trial. Active bacterial, fungal, or viral infections - all prior infections must have resolved following optimal therapy and subject must be off all systemic anti-infective agents. Chronic active hepatitis B or C.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Medical Monitor

Phone

617-500-8864

clinical@aurabiosciences.com

Facility Information:

Facility Name

Carolina Urologic Research Center

City

Myrtle Beach

State/Province

South Carolina

ZIP/Postal Code

29272

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jennifer Sutton

jsutton@curcmb.com

Facility Name

Urology Associates, P.C.

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37209

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mercedes Bruce

MBruce@ua-pc.com

Facility Name

Mary Crowley Cancer Research

City

Dallas

State/Province

Texas

ZIP/Postal Code

75251

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Joshua Matson

Phone

214-658-1987

jomatson@marycrowley.org

Facility Name

Baylor College of Medicine

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sharon Harrison

sharons@bcm.edu

12. IPD Sharing Statement

Learn more about this trial

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

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