NCT05787496 · OUTCOME

Area Under the Serum Concentration Versus Time Curve (AUC) of NC525

A Safety, Tolerability and Efficacy Study of NC525 in Subjects With Advanced Myeloid Neoplasms · Source last updated 2026-01-28

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: MEAN
Unit: h*μg/mL
Interval / dispersion: Standard Deviation
Time frame: During Cycles 1, 2, 3, 5, 7, and 11 (each cycle is 28 days), Cycle 1 reported

What was measured

To evaluate area under the serum concentration versus time curve (AUC) of NC525

Analysis population: The PK analysis set includes participants who received NC525 and had sufficient concentration-time data to estimate AUC using noncompartmental analysis for Cycle 1 Day 1. Participants without adequate quantifiable PK samples were excluded for this parameter. Descriptive statistics were calculated when multiple participants had estimable AUC values. When only one participant had an estimable value, the mean is reported and the standard deviation is not calculable.

Groups in this outcome

2mg/kg NC525

Subjects received NC525 IV at 2mg/kg bi-weekly (Q2W) for Cycles 1-6, followed by every 4 weeks (Q4W) thereafter. NC525: Monoclonal antibody specific for LAIR-1

2.5mg/kg NC525

Subjects received NC525 IV at 2.5mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing. Subjects in Cohort 2 initially received 3mg/kg weekly but dose was reduced to 2.5mg/kg weekly at FDA request due to change in dosing frequency from Q2W to QW. NC525: Monoclonal antibody specific for LAIR-1

4.5mg/kg NC525

Subjects received NC525 IV at 4.5mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing. NC525: Monoclonal antibody specific for LAIR-1

9mg/kg NC525

Subjects received NC525 IV at 9mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing. NC525: Monoclonal antibody specific for LAIR-1

13.5mg/kg NC525

Subjects received NC525 IV at 13.5mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing. NC525: Monoclonal antibody specific for LAIR-1

18mg/kg NC525

Subjects received NC525 IV at 18mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing. NC525: Monoclonal antibody specific for LAIR-1

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

Group	Source count
2mg/kg NC525	1
2.5mg/kg NC525	4
4.5mg/kg NC525	3
9mg/kg NC525	9
13.5mg/kg NC525	4
18mg/kg NC525	3

Reported measurements

Source class 1

Values in h*μg/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
2mg/kg NC525	5540	NA	Not reported	Not reported	Standard deviation is not calculable because only one participant had an estimable AUC value in this Arm/Group.
2.5mg/kg NC525	2180	755	Not reported	Not reported	Not reported
4.5mg/kg NC525	5430	963	Not reported	Not reported	Not reported
9mg/kg NC525	13000	4480	Not reported	Not reported	Not reported
13.5mg/kg NC525	23900	8360	Not reported	Not reported	Not reported
18mg/kg NC525	33700	19600	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
comment
Standard deviation is not calculable because only one participant had an estimable AUC value in this Arm/Group.
group Id
OG000
spread
NA
value
5540
group Id
OG001
spread
755
value
2180
group Id
OG002
spread
963
value
5430
group Id
OG003
spread
4480
value
13000
group Id
OG004
spread
8360
value
23900
group Id
OG005
spread
19600
value
33700

denoms

counts
group Id
OG000
value
1
group Id
OG001
value
4
group Id
OG002
value
3
group Id
OG003
value
9
group Id
OG004
value
4
group Id
OG005
value
3
units
Participants

description

To evaluate area under the serum concentration versus time curve (AUC) of NC525

dispersion Type

Standard Deviation

groups

description
Subjects received NC525 IV at 2mg/kg bi-weekly (Q2W) for Cycles 1-6, followed by every 4 weeks (Q4W) thereafter. NC525: Monoclonal antibody specific for LAIR-1
id
OG000
title
2mg/kg NC525
description
Subjects received NC525 IV at 2.5mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing. Subjects in Cohort 2 initially received 3mg/kg weekly but dose was reduced to 2.5mg/kg weekly at FDA request due to change in dosing frequency from Q2W to QW. NC525: Monoclonal antibody specific for LAIR-1
id
OG001
title
2.5mg/kg NC525
description
Subjects received NC525 IV at 4.5mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing. NC525: Monoclonal antibody specific for LAIR-1
id
OG002
title
4.5mg/kg NC525
description
Subjects received NC525 IV at 9mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing. NC525: Monoclonal antibody specific for LAIR-1
id
OG003
title
9mg/kg NC525
description
Subjects received NC525 IV at 13.5mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing. NC525: Monoclonal antibody specific for LAIR-1
id
OG004
title
13.5mg/kg NC525
description
Subjects received NC525 IV at 18mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing. NC525: Monoclonal antibody specific for LAIR-1
id
OG005
title
18mg/kg NC525

param Type

MEAN

population Description

The PK analysis set includes participants who received NC525 and had sufficient concentration-time data to estimate AUC using noncompartmental analysis for Cycle 1 Day 1. Participants without adequate quantifiable PK samples were excluded for this parameter. Descriptive statistics were calculated when multiple participants had estimable AUC values. When only one participant had an estimable value, the mean is reported and the standard deviation is not calculable.

reporting Status

POSTED

time Frame

During Cycles 1, 2, 3, 5, 7, and 11 (each cycle is 28 days), Cycle 1 reported

title

Area Under the Serum Concentration Versus Time Curve (AUC) of NC525

type

SECONDARY

unit Of Measure

h*μg/mL

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Preserved source evidence · Not medical advice