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NCT05787496 · OUTCOME

Terminal Half-life (t1/2) 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
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 the Terminal Half-life (t1/2) of NC525.

Analysis population: The PK analysis set includes participants who received NC525 and had sufficient concentration-time data to estimate terminal half-life (t1/2) using noncompartmental analysis. Estimation required an identifiable terminal elimination phase with ≥3 quantifiable post-dose samples. Descriptive statistics were calculated when ≥3 participants had an estimable t1/2. When only 1 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

GroupSource count
2mg/kg NC5250
2.5mg/kg NC5253
4.5mg/kg NC5250
9mg/kg NC5251
13.5mg/kg NC5251
18mg/kg NC5250

Reported measurements

Source class 1
Values in h · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
2.5mg/kg NC52549.819.6Not reportedNot reportedNot reported
9mg/kg NC52555.3NANot reportedNot reportedStandard deviation is not calculable because only one participant had an estimable terminal half-life (t1/2) value in this Arm/Group.
13.5mg/kg NC52564.2NANot reportedNot reportedStandard deviation is not calculable because only one participant had an estimable terminal half-life (t1/2) value in this Arm/Group.
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG001
        spread
        19.6
        value
        49.8
      2. comment
        Standard deviation is not calculable because only one participant had an estimable terminal half-life (t1/2) value in this Arm/Group.
        group Id
        OG003
        spread
        NA
        value
        55.3
      3. comment
        Standard deviation is not calculable because only one participant had an estimable terminal half-life (t1/2) value in this Arm/Group.
        group Id
        OG004
        spread
        NA
        value
        64.2
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    2. group Id
      OG001
      value
      3
    3. group Id
      OG002
      value
      0
    4. group Id
      OG003
      value
      1
    5. group Id
      OG004
      value
      1
    6. group Id
      OG005
      value
      0
    units
    Participants
description
To evaluate the Terminal Half-life (t1/2) of NC525.
dispersion Type
Standard Deviation
groups
  1. 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
  2. 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
  3. 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
  4. 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
  5. 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
  6. 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 terminal half-life (t1/2) using noncompartmental analysis. Estimation required an identifiable terminal elimination phase with ≥3 quantifiable post-dose samples. Descriptive statistics were calculated when ≥3 participants had an estimable t1/2. When only 1 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
Terminal Half-life (t1/2) of NC525
type
SECONDARY
unit Of Measure
h

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Preserved source evidence · Not medical advice