Trial Outcomes & Findings for PK Sub-Study of QUILT-3.032 (CA ALT-803-01-16) and of QUILT-2.005 (CA ALT-803-01-14) (NCT NCT04142359)
NCT ID: NCT04142359
Last Updated: 2024-12-10
Results Overview
Half-life (t½)
Recruitment status
TERMINATED
Target enrollment
1 participants
Primary outcome timeframe
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.
Results posted on
2024-12-10
Participant Flow
Participant milestones
| Measure |
Cohort A: CIS (Either Study)
Patients with histologically confirmed presence of BCG-unresponsive CIS, \[with or without Ta/T1 papillary disease\].
BCG in Combination with N-803: BCG in Combination with 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
BCG in Combination with N-803: BCG in Combination with N-803
|
Cohort C: CIS (QUILT-3.032)
Patients with histologically confirmed presence of BCG-unresponsive CIS, \[with or without Ta/T1 papillary disease\].
N-803 alone: N-803 alone
|
|---|---|---|---|
|
Overall Study
STARTED
|
1
|
0
|
0
|
|
Overall Study
COMPLETED
|
1
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
PK Sub-Study of QUILT-3.032 (CA ALT-803-01-16) and of QUILT-2.005 (CA ALT-803-01-14)
Baseline characteristics by cohort
| Measure |
Cohort A: CIS (Either Study)
n=1 Participants
Patients with histologically confirmed presence of BCG-unresponsive CIS, \[with or without Ta/T1 papillary disease\].
BCG in Combination with N-803: BCG in Combination with 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
BCG in Combination with N-803: BCG in Combination with N-803
|
Cohort C: CIS (QUILT-3.032)
Patients with histologically confirmed presence of BCG-unresponsive CIS, \[with or without Ta/T1 papillary disease\].
N-803 alone: N-803 alone
|
Total
n=1 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
73 years
STANDARD_DEVIATION NA • n=5 Participants
|
—
|
—
|
73 years
STANDARD_DEVIATION NA • n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Non-muscle invasive bladder cancer enrolled on either QUILT-3.032 or QUILT-2.005
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 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.Population: Systemic N-803 was below the limit of quantitation for all subjects at all time points assessed. Following intravesical administration, there was no evidence of systemic N-803 in any subject. PK parameters were not calculated.
Half-life (t½)
Outcome measures
| Measure |
Cohort A: CIS (Either Study)
n=1 Participants
Patients with histologically confirmed presence of BCG-unresponsive CIS, \[with or without Ta/T1 papillary disease\].
BCG in Combination with N-803: BCG in Combination with 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
BCG in Combination with N-803: BCG in Combination with N-803
|
Cohort C: CIS (QUILT-3.032)
Patients with histologically confirmed presence of BCG-unresponsive CIS, \[with or without Ta/T1 papillary disease\].
N-803 alone: N-803 alone
|
|---|---|---|---|
|
Half-life (t½)
|
NA Hours
Standard Deviation NA
Systemic N-803 was below the limit of quantitation at all time points assessed. Thus, there was no evidence of systemic N-803 exposure after intravesical administration.
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.Population: Systemic N-803 was below the limit of quantitation for all subjects at all time points assessed. Following intravesical administration, there was no evidence of systemic N-803 in any subject. PK parameters were not calculated.
Apparent (extravascular) volume of distribution (Vz/F)
Outcome measures
| Measure |
Cohort A: CIS (Either Study)
n=1 Participants
Patients with histologically confirmed presence of BCG-unresponsive CIS, \[with or without Ta/T1 papillary disease\].
BCG in Combination with N-803: BCG in Combination with 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
BCG in Combination with N-803: BCG in Combination with N-803
|
Cohort C: CIS (QUILT-3.032)
Patients with histologically confirmed presence of BCG-unresponsive CIS, \[with or without Ta/T1 papillary disease\].
N-803 alone: N-803 alone
|
|---|---|---|---|
|
Apparent (Extravascular) Volume of Distribution (Vz/F)
|
NA mL/kg
Standard Deviation NA
Systemic N-803 was below the limit of quantitation at all time points assessed. Thus, there was no evidence of systemic N-803 exposure after intravesical administration.
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.Population: Systemic N-803 was below the limit of quantitation for all subjects at all time points assessed. Following intravesical administration, there was no evidence of systemic N-803 in any subject. PK parameters were not calculated.
Apparent (extravascular) clearance (CL/F)
Outcome measures
| Measure |
Cohort A: CIS (Either Study)
n=1 Participants
Patients with histologically confirmed presence of BCG-unresponsive CIS, \[with or without Ta/T1 papillary disease\].
BCG in Combination with N-803: BCG in Combination with 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
BCG in Combination with N-803: BCG in Combination with N-803
|
Cohort C: CIS (QUILT-3.032)
Patients with histologically confirmed presence of BCG-unresponsive CIS, \[with or without Ta/T1 papillary disease\].
N-803 alone: N-803 alone
|
|---|---|---|---|
|
Apparent (Extravascular) Clearance (CL/F)
|
NA L/day/kg
Standard Deviation NA
Systemic N-803 was below the limit of quantitation at all time points assessed. Thus, there was no evidence of systemic N-803 exposure after intravesical administration.
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.Population: Systemic N-803 was below the limit of quantitation for all subjects at all time points assessed. Following intravesical administration, there was no evidence of systemic N-803 in any subject. PK parameters were not calculated.
Maximum observed concentration (Cmax)
Outcome measures
| Measure |
Cohort A: CIS (Either Study)
n=1 Participants
Patients with histologically confirmed presence of BCG-unresponsive CIS, \[with or without Ta/T1 papillary disease\].
BCG in Combination with N-803: BCG in Combination with 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
BCG in Combination with N-803: BCG in Combination with N-803
|
Cohort C: CIS (QUILT-3.032)
Patients with histologically confirmed presence of BCG-unresponsive CIS, \[with or without Ta/T1 papillary disease\].
N-803 alone: N-803 alone
|
|---|---|---|---|
|
Maximum Observed Concentration (Cmax)
|
NA pg/mL
Standard Deviation NA
Systemic N-803 was below the limit of quantitation at all time points assessed. Thus, there was no evidence of systemic N-803 exposure after intravesical administration.
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.Population: Systemic N-803 was below the limit of quantitation for all subjects at all time points assessed. Following intravesical administration, there was no evidence of systemic N-803 in any subject. PK parameters were not calculated.
Time of the observed maximum concentration (Tmax)
Outcome measures
| Measure |
Cohort A: CIS (Either Study)
n=1 Participants
Patients with histologically confirmed presence of BCG-unresponsive CIS, \[with or without Ta/T1 papillary disease\].
BCG in Combination with N-803: BCG in Combination with 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
BCG in Combination with N-803: BCG in Combination with N-803
|
Cohort C: CIS (QUILT-3.032)
Patients with histologically confirmed presence of BCG-unresponsive CIS, \[with or without Ta/T1 papillary disease\].
N-803 alone: N-803 alone
|
|---|---|---|---|
|
Time of the Observed Maximum Concentration (Tmax)
|
NA Days
Standard Deviation NA
Systemic N-803 was below the limit of quantitation at all time points assessed. Thus, there was no evidence of systemic N-803 exposure after intravesical administration.
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.Population: Systemic N-803 was below the limit of quantitation for all subjects at all time points assessed. Following intravesical administration, there was no evidence of systemic N-803 in any subject. PK parameters were not calculated.
Area under the plasma concentration curve from time 0 through the last measurable concentration (AUC0-t)
Outcome measures
| Measure |
Cohort A: CIS (Either Study)
n=1 Participants
Patients with histologically confirmed presence of BCG-unresponsive CIS, \[with or without Ta/T1 papillary disease\].
BCG in Combination with N-803: BCG in Combination with 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
BCG in Combination with N-803: BCG in Combination with N-803
|
Cohort C: CIS (QUILT-3.032)
Patients with histologically confirmed presence of BCG-unresponsive CIS, \[with or without Ta/T1 papillary disease\].
N-803 alone: N-803 alone
|
|---|---|---|---|
|
Area Under the Plasma Concentration Curve From Time 0 Through the Last Measurable Concentration (AUC0-t)
|
NA Day*pg/mL
Standard Deviation NA
Systemic N-803 was below the limit of quantitation at all time points assessed. Thus, there was no evidence of systemic N-803 exposure after intravesical administration.
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.Population: Systemic N-803 was below the limit of quantitation for all subjects at all time points assessed. Following intravesical administration, there was no evidence of systemic N-803 in any subject. PK parameters were not calculated.
Area under the plasma concentration curve from time 0 extrapolated to infinite time (AUC0-inf)
Outcome measures
| Measure |
Cohort A: CIS (Either Study)
n=1 Participants
Patients with histologically confirmed presence of BCG-unresponsive CIS, \[with or without Ta/T1 papillary disease\].
BCG in Combination with N-803: BCG in Combination with 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
BCG in Combination with N-803: BCG in Combination with N-803
|
Cohort C: CIS (QUILT-3.032)
Patients with histologically confirmed presence of BCG-unresponsive CIS, \[with or without Ta/T1 papillary disease\].
N-803 alone: N-803 alone
|
|---|---|---|---|
|
Area Under the Plasma Concentration Curve From Time 0 Extrapolated to Infinite Time (AUC0-inf)
|
NA Day*pg/mL
Standard Deviation NA
Systemic N-803 was below the limit of quantitation at all time points assessed. Thus, there was no evidence of systemic N-803 exposure after intravesical administration.
|
—
|
—
|
Adverse Events
Cohort A: CIS (Either Study)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort B: High-Grade Ta/T1 Papillary Disease (Either Study)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort C: CIS (QUILT-3.032)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place