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PK Sub-Study of QUILT-3.032 (CA ALT-803-01-16) and of QUILT-2.005 (CA ALT-803-01-14)

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ClinicalTrials.gov Identifier: NCT04142359
Recruitment Status : Terminated (Study was closed due to the recent pandemic and enrollment challenges.)
First Posted : October 29, 2019
Last Update Posted : January 22, 2021
Sponsor:
Information provided by (Responsible Party):
Altor BioScience

Brief Summary:
Non-interventional PK sub-study of QUILT-3.032 (CA-ALT-803-01-16) and QUILT-2.005 (CA-ALT-803-01-14)

Condition or disease Intervention/treatment
Pharmacokinetics Biological: BCG in Combination with N-803 Drug: N-803 alone

Detailed Description:

QUILT-3.032 is a Phase 2, open-label, single-arm, three-cohort, multicenter study of intravesical BCG plus ALT-803 in patients with BCG unresponsive high grade NMIBC. Patients will be enrolled into one of three study cohorts. Cohort A will enroll 80 patients who have histologically confirmed presence of BCG-unresponsive carcinoma in situ (CIS) [with or without Ta or T1 disease]. Cohort B will enroll 80 patients who have histologically confirmed BCG-unresponsive high-grade Ta or T1 disease. Cohort C will enroll up to 23 patients who also have histologically confirmed presence of BCG-unresponsive CIS [with or without Ta/T1 papillary disease]. Patients in Cohorts A and B will receive ALT-803 plus BCG combination treatment. Patients in Cohort C will receive ALT-803 alone. Enrollment of Cohort C will start once the enrollment of Cohort A is complete. Cohorts A, B, and C are independent study cohorts and will be separately evaluated for efficacy. All patients treated in the study will receive via a urinary catheter in the bladder, BCG plus ALT-803 or ALT-803 alone weekly for 6 consecutive weeks during the induction treatment period.

QUILT-2.005 is a phase 2b, randomized, two-cohort, open-label, multicenter study of intravesical ALT-803 plus BCG versus BCG alone, in BCG naïve patients with high-grade NMIBC. Patients will be enrolled into one of two study cohorts and randomized into two arms to be treated with either ALT-803 plus BCG or BCG alone. Cohort A will initially enroll 366 patients who have histologically confirmed CIS (with or without Ta/T1 papillary disease). Cohort B will initially enroll 230 patients who have histologically confirmed high-grade papillary Ta/T1 disease only. Cohorts A and B are two independent study cohorts and will be evaluated separately for efficacy.

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 either cohort A (either study) or cohort C (QUILT 3.032) and six subjects from cohort B (either study) will be sampled initially. Up to an additional 4 subjects for each cohort may also be sampled. Patients enrolled in QUILT 2.005 must have been randomized to receive ALT-803 plus BCG to be eligible for the PK sub-study.

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Study Type : Observational
Actual Enrollment : 1 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: 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 and QUILT-2.005: A Study of Intravesical BCG in Combination With ALT-803 in Patients With Non-Muscle Invasive Bladder Cancer
Actual Study Start Date : October 11, 2019
Actual Primary Completion Date : April 6, 2020
Actual Study Completion Date : April 6, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Cohort A: CIS (either study)
Patients with histologically confirmed presence of BCG-unresponsive CIS, [with or without Ta/T1 papillary disease].
Biological: BCG in Combination with N-803
BCG in Combination with N-803
Other Name: N-803

Cohort B: High-Grade Ta/T1 Papillary Disease (either study)
Patients with histologically confirmed presence of BCG-unresponsive high-grade Ta/T1 papillary disease
Biological: BCG in Combination with N-803
BCG in Combination with N-803
Other Name: N-803

Cohort C: CIS (QUILT-3.032)
Patients with histologically confirmed presence of BCG-unresponsive CIS, [with or without Ta/T1 papillary disease].
Drug: N-803 alone
N-803 alone




Primary Outcome Measures :
  1. PK Parameter [ 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. ]
    Half-life (t½)

  2. PK Parameter [ 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. ]
    Apparent (extravascular) volume of distribution (Vz/F)

  3. PK Parameter [ 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. ]
    Apparent (extravascular) clearance (CL/F)

  4. PK Parameter [ 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. ]
    Maximum observed concentration (Cmax)

  5. PK Parameter [ 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. ]
    Time of the observed maximum concentration (Tmax)

  6. PK Parameter [ 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. ]
    Area under the plasma concentration curve from time 0 through the last measurable concentration (AUC0-t)

  7. PK Parameter [ 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. ]
    Area under the plasma concentration curve from time 0 extrapolated to infinite time (AUC0-inf)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Six subjects from either Cohort A (either study) or Cohort C (QUILT-3.032) and six subjects from Cohort B (either study) will be sampled initially in this PK sub-study. Up to an additional 4 subjects from each cohort may also be sampled.
Criteria

Inclusion Criteria:

  • Only subjects who are eligible for and have entered into protocol QUILT-3.032 or QUILT-2.005 may participate in this sub-study.
  • Patients enrolled in QUILT-2.005 must have been randomized to receive ALT-803 plus BCG to 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04142359


Locations
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United States, California
UCLA Department of Urology
Los Angeles, California, United States, 90024
United States, Florida
University of Miami Miller School of Medicine-Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136
United States, Nebraska
Adult & Pediatric Urology
Omaha, Nebraska, United States, 68114
United States, New York
NYU Winthrop University Hospital Department of Urology
Garden City, New York, United States, 11530
Manhattan Medical Research
New York, New York, United States, 10016
United States, Virginia
Virginia Urology
Richmond, Virginia, United States, 23235
Sponsors and Collaborators
Altor BioScience
Investigators
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Study Director: Chad Garner, PhD ImmunityBio, Inc.
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Responsible Party: Altor BioScience
ClinicalTrials.gov Identifier: NCT04142359    
Other Study ID Numbers: QUILT-3.032-2.005-PK
First Posted: October 29, 2019    Key Record Dates
Last Update Posted: January 22, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No