Summary

for people ages 18 years and up (full criteria)
at Sacramento, California and other locations
study started
estimated completion

Description

Summary

This study, BC-819-18-204, is a Phase 2, open-label, monotherapy, single-arm, multicenter clinical trial of BC-819 (inodiftagene vixteplasmid) in patients with NMIBC adequately treated with Bacillus Calmette-Guerin (BCG) whose disease is BCG unresponsive according to the US Food and Drug Administration (FDA) guidance.

Official Title

A Phase 2 Study of BC-819 in Patients With Non-Muscle Invasive Bladder Cancer Whose Disease is Unresponsive to Bacillus Calmette-Guerin

Details

BC-819 (inodiftagene vixteplasmid) is a recombinant DNA plasmid that directs the expression of a potent toxin specifically in malignant cells but not in normal tissue. It has been designed to exploit the established biology of the H19 gene, which is upregulated and expressed at high levels only in malignant cells, to produce bacterial diphtheria toxin only in bladder cancer tissue. BC-819 is administered directly into the bladder to enable maximal topical exposure to target bladder cancer cells.

Keywords

Non-muscle Invasive Bladder Cancer (NMIBC) BCG-unresponsive Urinary Bladder Neoplasms inodiftagene vixteplasmid

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Male or female patients ≥18 years of age at the time of consent
  2. Patient must have been adequately treated with BCG defined as at least one of the following (FDA 2018):
  3. At least five of six doses of an initial induction course plus at least two of three doses of maintenance therapy
  4. At least five of six doses of an initial induction course plus at least two of six doses of a second induction course
  5. A single course of induction BCG can qualify if the patient has T1 high-grade disease at first evaluation (see 3c)
  6. Patient must be BCG-unresponsive defined as at least one of the following (FDA 2018):
  7. Persistent or recurrent CIS alone or with recurrent Ta/T1 disease within 12 months of completion of adequate BCG therapy. An assessment within 15 months can also qualify when no assessment was done 12 months after completion of adequate BCG therapy.
  8. Recurrent high-grade Ta/T1 disease within 6 months of completion of adequate BCG therapy. An assessment within 9 months can also qualify when no assessment was done 6 months after completion of adequate BCG therapy.
  9. T1 high-grade disease at the first evaluation following a single course of induction BCG qualifies (Lerner et al. 2015, Steinberg et al. 2016)
  10. Patient must have, at study entry, NMIBC indicated by 1 or more of the following:
  11. Ta or T1 high-grade disease
  12. CIS disease
  13. Patient must have no known evidence of concomitant upper tract urothelial carcinoma or urothelial carcinoma within the prostatic urethra within 6 months of enrollment
  14. Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status ≤2
  15. Patient must have adequate hematologic function, as demonstrated by the following:
  16. Hemoglobin level ≥10 g/dL
  17. Absolute neutrophil count ≥1.5 x 109/L
  18. Platelet count ≥100 x 109/L
  19. Patient must have adequate liver and renal function as demonstrated by the following:
  20. Aspartate aminotransferase and alanine aminotransferase each ≤3.0 x upper limit of normal
  21. Total bilirubin ≤1.5 x upper limit of normal, unless prior documentation of Gilbert's syndrome in which case, 3.0 mg/dL is allowed
  22. Serum creatinine ≤1.5 x upper limit of normal or measured or calculated creatinine clearance ≥30 mL/min
  23. Female patients of childbearing potential must use maximally effective birth control during the period of therapy and for 1 month after the last study drug infusion
  24. . Male patients who are sexually active must be willing to use a double barrier contraceptive method upon study enrollment, during the course of the study, and for 1 month after the last study drug infusion

You CAN'T join if...

  1. Patient has current or previous evidence of muscle invasive (muscularis propria) or metastatic bladder cancer disease
  2. Patient has received prior investigational therapy for NMIBC
  3. Patient has received any therapy for NMIBC within 10 weeks before the start of study treatment other than surgical resection, 1 dose of chemotherapy, and previous BCG
  4. Patient is intolerant to previous BCG treatment in the absence of meeting other criteria for BCG unresponsiveness and adequate BCG therapy
  5. Patient has received external beam radiation therapy for bladder cancer at any time or for any other condition
  6. Patient has an active infection, including urinary tract infection (viral, bacterial, or fungal) and cystitis
  7. Patient has urinary tract signs or symptoms that preclude retention of drug in the bladder; this does not include anticholinergic drugs
  8. Patient is known to have tested positive for human immunodeficiency virus (HIV). No HIV testing is required if patient is not known have tested positive
  9. Patient is female and is pregnant or breastfeeding
  10. . Patient has a known presence or history of malignancy of other organ system within the 5 years before study start, with the exception of non-melanoma skin cancer; very low or low-risk prostate cancer; or patients who have been disease free for at least 2 years following stage 1 or 2 cancer

Locations

  • UC Davis Medical Center accepting new patients
    Sacramento California 95817 United States
  • Idaho Urologic Institute, PA accepting new patients
    Meridian Idaho 83642 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Anchiano Therapeutics Israel Ltd.
Links
Sign up for this study
ID
NCT03719300
Phase
Phase 2
Study Type
Interventional
Last Updated