NCT05209152 · OUTCOME

Maximum Plasma Concentration (Cmax) of AMG 176

AMG 176 With Azacitidine in Subjects With Myelodysplastic Syndrome /Chronic Myelomonocytic Leukemia · Source last updated 2025-07-14

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

Measure: MEAN
Unit: ng/mL
Interval / dispersion: Standard Deviation
Time frame: Cycle 1: pre-dose, end of infusion (EOI), 3, 5, 7, 8, 24 hours post-infusion in weeks 1 and 2; pre-dose, EOI, 8 and 24 hours post-infusion in cycle 1 weeks 3 and 4

What was measured

AMG 176 plasma concentrations with values below the limit of quantification were set to zero. Pharmacokinetic (PK) parameters were determined from the time concentration profile using noncompartmental analysis.

Analysis population: The PK analysis set included all participants who received at least 1 dose of AMG 176 and had at least 1 PK sample collected.

Groups in this outcome

Part 1A Dose Exploration: AMG 176 Dose Level 1

Participants received IV AMG 176 at dose level 1 once a week in 28-day cycles. Treatment was planned until disease progression or unacceptable toxicity.

Part 1A Dose Exploration: AMG 176 Dose Level 1 Then Dose Level 2

Participants received IV AMG 176 at dose level 1 on cycle 1 day 1 and then dose level 2 from cycle 1 day 8 and once a week thereafter (each cycle = 28 days). Treatment was planned until disease progression or unacceptable toxicity.

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
Part 1A Dose Exploration: AMG 176 Dose Level 1	4
Part 1A Dose Exploration: AMG 176 Dose Level 1 Then Dose Level 2	3

Reported measurements

Cycle 1 day 1

Values in ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Part 1A Dose Exploration: AMG 176 Dose Level 1	18600	16600	Not reported	Not reported	Not reported
Part 1A Dose Exploration: AMG 176 Dose Level 1 Then Dose Level 2	5650	1790	Not reported	Not reported	Not reported

Cycle 1 day 8

Values in ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Part 1A Dose Exploration: AMG 176 Dose Level 1	19500	6600	Not reported	Not reported	Not reported
Part 1A Dose Exploration: AMG 176 Dose Level 1 Then Dose Level 2	14900	5060	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
16600
value
18600
group Id
OG001
spread
1790
value
5650
title
Cycle 1 day 1
categories
measurements
group Id
OG000
spread
6600
value
19500
group Id
OG001
spread
5060
value
14900
title
Cycle 1 day 8

denoms

counts
group Id
OG000
value
4
group Id
OG001
value
3
units
Participants

description

dispersion Type

Standard Deviation

groups

description
Participants received IV AMG 176 at dose level 1 once a week in 28-day cycles. Treatment was planned until disease progression or unacceptable toxicity.
id
OG000
title
Part 1A Dose Exploration: AMG 176 Dose Level 1
description
Participants received IV AMG 176 at dose level 1 on cycle 1 day 1 and then dose level 2 from cycle 1 day 8 and once a week thereafter (each cycle = 28 days). Treatment was planned until disease progression or unacceptable toxicity.
id
OG001
title
Part 1A Dose Exploration: AMG 176 Dose Level 1 Then Dose Level 2

param Type

MEAN

population Description

The PK analysis set included all participants who received at least 1 dose of AMG 176 and had at least 1 PK sample collected.

reporting Status

POSTED

time Frame

Cycle 1: pre-dose, end of infusion (EOI), 3, 5, 7, 8, 24 hours post-infusion in weeks 1 and 2; pre-dose, EOI, 8 and 24 hours post-infusion in cycle 1 weeks 3 and 4

title

Maximum Plasma Concentration (Cmax) of AMG 176

type

SECONDARY

unit Of Measure

ng/mL

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Preserved source evidence · Not medical advice