Status:
COMPLETED
A Phase 1 Study of Intravesical VAX014 for Instillation in Subjects With Non-Muscle Invasive Bladder Cancer
Lead Sponsor:
Vaxiion Therapeutics
Conditions:
Urothelial Carcinoma of the Urinary Bladder
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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). VAX01...
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 Do...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 10 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2023
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT03854721
Start Date
May 10 2019
End Date
March 1 2023
Last Update
March 3 2023
Active Locations (5)
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1
The Urology Center of Colorado
Denver, Colorado, United States, 80211
2
University of Iowa Hospital and Clinics
Iowa City, Iowa, United States, 52242
3
New Jersey Urology, LLC.
Edison, New Jersey, United States, 08837
4
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States, 29572