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BRIEF TITLE: Study of QUILT-3.032 (CA ALT-803-01-16): A Multicenter Clinical Trial of Intravesical Bacillus Calmette-Guerin (BCG) in Combination With ALT-803 in Patients With BCG Unresponsive High Grade Non-Muscle Invasive Bladder Cancer

A Pharmacokinetic Sub-Study of QUILT-3.032 (CA ALT-803-01-16): A Multicenter Clinical Trial of Intravesical Bacillus Calmette-Guerin (BCG) in Combination With ALT-803 in Patients With BCG Unresponsive High Grade Non-Muscle Invasive Bladder Cancer


  • Org Study ID: QUILT-3.032-PK
  • Secondary ID:
  • NCT ID: NCT04142359
  • NCT Alias:
  • Sponsor: Altor BioScience - Industry
  • Source: Altor BioScience

Brief Summary

Non-interventional PK sub-study of QUILT-3.032 (CA-ALT-803-01-16)

Detailed Description


QUILT-3.032 (CA-ALT-803-01-16): Phase 2, open-label, single-arm, two cohort, multicenter
study of intravesical BCG plus ALT-803 (400 µg) in patients with BCG unresponsive high grade
NMIBC. Patients will be enrolled into one of two study cohorts. Cohort A will enroll 80
patients who have histologically confirmed presence of BCG-unresponsive carcinoma in situ
(CIS) [with or without Ta/T1 papillary disease]. Cohort B will enroll 80 patients who have
histologically confirmed BCG-unresponsive high-grade Ta/T1 papillary disease. Cohort A and B
are two independent study cohorts and will be separately evaluated for efficacy and safety.
The study will be conducted in conformity with Good Clinical Practice (GCP). All patients
treated in the study will receive via a urinary catheter in the bladder ALT-803 plus BCG,
weekly for 6 consecutive weeks during the induction treatment period.

PK sub-study: Blood samples to determine serum levels of ALT-803 will be collected on study
day 1 prior to dosing, and at post-bladder voiding (± 15 minutes), 24 (±2), 48 (±4), 72 (±4),
96 (±4) and 168 (±4) hours after dosing administered at study Week 1 and again at the same
time points for study Week 6. Six subjects from cohort A and six subjects from cohort B will
be sampled initially. Up to an additional 4 subjects from each cohort may also be sampled.

Overal Status Start Date Phase Study Type
Recruiting October 11, 2019 Observational

Primary Outcomes:

Primary Outcome 1 - Measure: PK Parameter

Primary Outcome 1 - Time Frame: Study day 1 prior to dosing, and at post-bladder voiding (± 15 minutes), 24 (±2), 48 (±4), 72 (±4), 96 (±4) and 168 (±4) hours after dosing administered at study Week 1 and again at the same time points for study Week 6.

Primary Outcome 2 - Measure: PK Parameter

Primary Outcome 2 - Time Frame: Study day 1 prior to dosing, and at post-bladder voiding (± 15 minutes), 24 (±2), 48 (±4), 72 (±4), 96 (±4) and 168 (±4) hours after dosing administered at study Week 1 and again at the same time points for study Week 6.

Primary Outcome 3 - Measure: PK Parameter

Primary Outcome 3 - Time Frame: Study day 1 prior to dosing, and at post-bladder voiding (± 15 minutes), 24 (±2), 48 (±4), 72 (±4), 96 (±4) and 168 (±4) hours after dosing administered at study Week 1 and again at the same time points for study Week 6.

Primary Outcome 4 - Measure: PK Parameter

Primary Outcome 4 - Time Frame: Study day 1 prior to dosing, and at post-bladder voiding (± 15 minutes), 24 (±2), 48 (±4), 72 (±4), 96 (±4) and 168 (±4) hours after dosing administered at study Week 1 and again at the same time points for study Week 6.

Primary Outcome 5 - Measure: PK Parameter

Primary Outcome 5 - Time Frame: Study day 1 prior to dosing, and at post-bladder voiding (± 15 minutes), 24 (±2), 48 (±4), 72 (±4), 96 (±4) and 168 (±4) hours after dosing administered at study Week 1 and again at the same time points for study Week 6.

Primary Outcome 6 - Measure: PK Parameter

Primary Outcome 6 - Time Frame: Study day 1 prior to dosing, and at post-bladder voiding (± 15 minutes), 24 (±2), 48 (±4), 72 (±4), 96 (±4) and 168 (±4) hours after dosing administered at study Week 1 and again at the same time points for study Week 6.

Primary Outcome 7 - Measure: PK Parameter

Primary Outcome 7 - Time Frame: Study day 1 prior to dosing, and at post-bladder voiding (± 15 minutes), 24 (±2), 48 (±4), 72 (±4), 96 (±4) and 168 (±4) hours after dosing administered at study Week 1 and again at the same time points for study Week 6.

Condition:

  • Pharmacokinetics

Eligibility

Criteria:
Inclusion Criteria:

- Only subjects who are eligible for and have entered into protocol QUILT-3.032 may
participate in this sub-study.

Exclusion Criteria:

- Refusal to provide voluntary written informed consent and HIPAA authorization and
agree to comply with all protocol-specified procedures and follow-up evaluations.

- Loss of ≥ 475 mL blood volume or blood transfusion of any blood product within 3
months prior to screening.
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Contact

Name: Laura Zambanini

Phone: 310-882-0912

Email: laura.zambanini@nantkwest.com

Locations

Facility Status Contact
Manhattan Medical Research
New York, New York 10016
United States
Recruiting Carmela Graci-Pipitone
212-480-3333
cgpipitone@manhattanmedicalresearch.com
Virginia Urology
Richmond, Virginia 23235
United States
Recruiting Christine Rose
804-288-2785
clrose@uro.com