NCT04442126 · OUTCOME

Maximum Tolerated Dose (MTD) of NM21-1480

A Study of NM21-1480 in Adult Patients With Advanced Solid Tumors · Source last updated 2025-05-23

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

Measure: NUMBER
Unit: mg
Interval / dispersion: Not reported
Time frame: Cycle 1 (28 days).

What was measured

To determine the MTD of NM21-1480 based on Part A. Note, No MTD was identified across all dose levels tested and a technical MTD was defined by the SMC as 800 mg following Part A, which was updated to 1400 mg by the SMC after completion of Part A-2.

Analysis population: MTD of NM21-1480 based on Part A and part A2. No MTD was identified across all dose levels tested and a technical MTD was defined by the SMC as 800 mg following Part A, which was updated to 1400 mg by the SMC after completion of Part A-2.

Groups in this outcome

Part A Dose Level 1 NM21-1480-Q2W 0.15mg

Part A Dose Level 2 NM21-1480-Q2W 1.5mg

Part A Dose Level 3 NM21-1480-Q2W 8mg

Part A Dose Level 4 NM21-1480-Q2W 24mg

Part A Dose Level 5 NM21-1480-Q2W 80mg

Part A Dose Level 6 NM21-1480-Q2W 240mg

Part A Dose Level 7 NM21-1480-Q2W 800mg

Part A2 NM21-1480-Q2W 1400mg

Part B NM21-1480-Q2W 800mg

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 A Dose Level 1 NM21-1480-Q2W 0.15mg	0
Part A Dose Level 2 NM21-1480-Q2W 1.5mg	0
Part A Dose Level 3 NM21-1480-Q2W 8mg	0
Part A Dose Level 4 NM21-1480-Q2W 24mg	0
Part A Dose Level 5 NM21-1480-Q2W 80mg	0
Part A Dose Level 6 NM21-1480-Q2W 240mg	0
Part A Dose Level 7 NM21-1480-Q2W 800mg	26
Part A2 NM21-1480-Q2W 1400mg	5
Part B NM21-1480-Q2W 800mg	0

Reported measurements

Source class 1

Values in mg · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part A Dose Level 7 NM21-1480-Q2W 800mg	800	Not reported	Not reported	Not reported	Not reported
Part A2 NM21-1480-Q2W 1400mg	1400	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG006
value
800
group Id
OG007
value
1400

denoms

counts
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
0
group Id
OG005
value
0
group Id
OG006
value
26
group Id
OG007
value
5
group Id
OG008
value
0
units
Participants

description

groups

description
Part A Dose Level 1 NM21-1480-Q2W 0.15mg
id
OG000
title
Part A Dose Level 1 NM21-1480-Q2W 0.15mg
description
Part A Dose Level 2 NM21-1480-Q2W 1.5mg
id
OG001
title
Part A Dose Level 2 NM21-1480-Q2W 1.5mg
description
Part A Dose Level 3 NM21-1480-Q2W 8mg
id
OG002
title
Part A Dose Level 3 NM21-1480-Q2W 8mg
description
Part A Dose Level 4 NM21-1480-Q2W 24mg
id
OG003
title
Part A Dose Level 4 NM21-1480-Q2W 24mg
description
Part A Dose Level 5 NM21-1480-Q2W 80mg
id
OG004
title
Part A Dose Level 5 NM21-1480-Q2W 80mg
description
Part A Dose Level 6 NM21-1480-Q2W 240mg
id
OG005
title
Part A Dose Level 6 NM21-1480-Q2W 240mg
description
Part A Dose Level 7 NM21-1480-Q2W 800mg
id
OG006
title
Part A Dose Level 7 NM21-1480-Q2W 800mg
description
Part A2 NM21-1480-Q2W 1400mg
id
OG007
title
Part A2 NM21-1480-Q2W 1400mg
description
Part B NM21-1480-Q2W 800mg
id
OG008
title
Part B NM21-1480-Q2W 800mg

param Type

NUMBER

population Description

MTD of NM21-1480 based on Part A and part A2. No MTD was identified across all dose levels tested and a technical MTD was defined by the SMC as 800 mg following Part A, which was updated to 1400 mg by the SMC after completion of Part A-2.

reporting Status

POSTED

time Frame

Cycle 1 (28 days).

title

Maximum Tolerated Dose (MTD) of NM21-1480

type

PRIMARY

unit Of Measure

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice