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Brief Title: A Phase 1 Study of Intravesical VAX014 for Instillation in Subjects With Non-Muscle Invasive Bladder Cancer

Phase I Safety and Tolerability of Intravesical VAX014 for Instillation in Subjects With Non-Muscle Invasive Bladder Cancer (NMIBC)

INTRODUCTION

  • Org Study ID: VX0116
  • Secondary ID: N/A
  • NTC ID: NCT03854721
  • Sponsor: Vaxiion Therapeutics

BRIEF SUMMARY

The purpose of this research study is to evaluate the safety, tolerability and activity of VAX014 for Instillation (VAX014) in patients with low-grade Non-Muscle Invasive Bladder Cancer (NMIBC). VAX014 is a targeted oncolytic agent designed to kill tumor cells following instillation into the urinary bladder.

DETAILED DESCRIPTION

This study will evaluate the safety and tolerability of VAX014 using a 3+3 dose escalation design to determine a maximum tolerated dose (MTD) followed by a dose expansion at the Recommended Phase 2 Dose (RP2D). Both phases of the study will use a Window of Opportunity study design where patients with a single, low-grade Ta lesion will receive VAX014 via a urinary catheter into the bladder, weekly for 6 weeks prior to undergoing Transurethral Resection of Bladder Tumor (TURBT) to assess antitumor activity against the mapped lesion.

Patients enrolled in this study must have low-grade (Ta) Non-Muscle Invasive Bladder Cancer. However, eligible patients may have up to 5 low-grade Ta lesions at screening, and all but a single mapped lesion will be resected prior to receiving VAX014. The mapped lesion is assessed for anti-tumor activity.

VAX014 is a formulation of recombinant bacterial minicells which is designed to selectively target two NMIBC-associated integrin heterodimers to de-stabilize tumor cell membranes, with the result being tumor cell lysis.

  • Overall Status
    Recruiting
  • Start Date
    May 10, 2019
  • Phase
    Phase 1
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Maximum tolerated dose (MTD) of VAX014

Primary Outcome 1 - Timeframe: up to 28 days

Primary Outcome 2 - Measure: Incidence of Treatment-Emergence Adverse Events (Safety and Tolerability)

Primary Outcome 2 - Timeframe: Through study completion, an average of 20 weeks

CONDITION

  • Urothelial Carcinoma of the Urinary Bladder

ELIGIBILITY

Inclusion Criteria:
Signed, informed consent

- Age 18 or more years

- Pathologically confirmed low-grade Ta urothelial carcinoma (UC) of the urinary bladder

- NMIBC with one solitary measurable tumor at the start of study, measuring ≥ 5 mm and ≤ 15 mm in greatest diameter (up to 4 additional low-grade Ta lesions, each measuring no more than 15 mm may be removed at screening provided a single lesion remains)

- Treatment-naïve or failed one previous regimen of intravesical therapy (BCG or chemotherapy)

- If recurrent disease, then more than 6 months from prior resection, more than 3 months from completion of last intravesical therapy with BCG, and more than 6 weeks from completion of last therapeutic intravesical therapy with chemotherapy

- If previously treated, recovered from prior treatment-related toxicity to ≤ Grade 1

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 116

- Absolute neutrophil count (ANC) ≥ 1,500/mm3

- Platelet count ≥ 100,000/mm3

- Total bilirubin ≤ 1.5 x upper limit of normal (ULN), or ≤ 3 x ULN in subjects with Gilberts disease

- Serum creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 30 mL/min

- Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) ≤ 2.5 x ULN

- Willingness to participate in collection of pharmacokinetic samples

- Women of childbearing potential must have a negative serum pregnancy test.

- All subjects of childbearing potential must be willing to use effective contraception while on treatment and for 3 months after the last dose of VAX014
Exclusion Criteria:
Additional papillary disease at screening (in addition to the solitary low-grade Ta lesion detailed in the inclusion criteria) that
Consist of 6 or more lesions

- Consists of any lesion with a maximal diameter of greater than 15 mm

- Confirmed or suspected perforated bladder

- History of difficult catheterization that in the opinion of the investigator will prevent administration of VAX014

- Presence or history of any high-grade urothelial cancer (including CIS) or high-grade urine cytology

- Intravesical chemo-or biological therapy within 6 months of first administration of VAX014

- UC of the ureters or urethra

- History of interstitial cystitis

- History of radiation to the pelvis

- History of vesicoureteral reflux or an indwelling urinary stent

- Other known active cancer(s) likely to require treatment or interfere with study objectives over the next two (2) years

- Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy

- Known HIV, Hepatitis B, or Hepatitis C infection

- Significant cardiovascular risk (e.g., coronary stenting within 8 weeks, myocardial infarction within 6 months)

- Major surgery other than diagnostic surgery within 4 weeks of first administration of VAX014

- Pregnant or currently breast-feeding

- Psychiatric illness/social situations that would interfere with compliance with study requirements

- Presence of any sessile appearing tumor suspected of being invasive or high-grade

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: N/A

Role: N/A

Affiliation: N/A

Overall Contact

Name: N/A

Phone: 858-630-1952

Email: jschulz@sciquus.com

LOCATION

Facility Status Contact
Facility: The Urology Center of Colorado
Denver, Colorado 80211
United States
Status: Recruiting Contact: Contact
Robin Dorsey, BA, CCRC
303-762-7155 1224
rdorsey@tucc.com
Facility: University of Iowa Hospital and Clinics
Iowa City, Iowa 52242
United States
Status: Recruiting Contact: Contact
Mary E Schall
319-356-3516 261
mary-schall@uiowa.edu
Facility: New Jersey Urology, LLC.
Edison, New Jersey 08837
United States
Status: Recruiting Contact: Contact
Haleema Hameed, Sr. CRC
732-494-9400
hhameed@premierurologygroup.com
Facility: Carolina Urologic Research Center
Myrtle Beach, South Carolina 29572
United States
Status: Recruiting Contact: Contact
Stacy Rust, RMA, CRC
843-449-1010
srust@curcmb.com
Facility: Baylor College of Medicine
Houston, Texas 77030
United States
Status: Recruiting Contact: Contact
Sharon Harrison
713-798-2240
sharons@bcm.edu