Bladder Cancer CA-ALT-803-01-14

April 11, 2017

Sponsor: Altor Bioscience Corporation

Number: CA-ALT-803-01-14

The purpose of this study is to evaluate the safety, identify the Maximum Tolerated Dose (MTD) of ALT-803 and determine the Recommended Dose (RD) level of ALT-803 combined with BCG in patients who have nonmuscle invasive bladder cancer. The anti-tumor activity of BCG+ALT-803 will also be assessed. In addition, the study will characterize the molecular, immunogenicity and pharmacokinetic profile of BCG+ALT-803.

The study includes a dose escalation phase 1b (Phase Ib- Multiple ascending dose studies investigate the movement of drugs within the body, the effects of drugs, and the mechanism of action of multiple doses of the drug which includes safety and tolerability) and an expansion phase II (Phase II: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety). The dose escalation phase is concluded when the MTD is determined. A dose level (RD) will be designated for the phase II study. For the non-comparative randomized phase II trial, patients will be randomized (randomly assigned by chance) to two treatment arms: either ALT-803 at the RD level in combination with BCG (50 mg) or BCG (50 mg) alone.

Who’s eligible:

  • The patient must have histologic confirmation (tissue microscopically examined) of non-muscle invasive bladder cancer of the transitional cell carcinoma high-risk subtype.
    • No evidence of muscle-invasive bladder cancer or regional and/or distant metastasis (the development of secondary malignant growths at a distance from a primary site of cancer).
    • High risk is defined as any high-grade Ta or T1, CIS (non-muscle-invasive bladder cancer).
  • No prior BCG treatment.
  • No concurrent use of other investigational agents.
  • This study is for patients age 18 and older.

Available at: Backus Hospital- Eastern Connecticut Hematology and Oncology.

Cancer Clinical Research Office