NCT03576131 · OUTCOME

Number of Participants With Dose Limiting Toxicities (DLTs)

GEN1029 (HexaBody®-DR5/DR5) Safety Trial in Patients With Malignant Solid Tumors · Source last updated 2023-08-01

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

Measure: COUNT_OF_PARTICIPANTS
Unit: Participants
Interval / dispersion: Not reported
Time frame: From Day 1 to 28 days after the first dose of study drug

What was measured

DLT criteria in the dose escalation phase of this trial are defined as hematologic toxicity including Grade (G) 4 neutropenia/thrombocytopenia for minimal duration of 7 days, G3/4 febrile neutropenia, \>=G3 thrombocytopenia with bleeding, or G4 anemia; and non-hematologic toxicity including G4 infusion-related reactions (IRR) or anaphylaxis, G3 IRR did not resolve to =\<G1 within 24 hours, \>=G3 diarrhea/vomiting (did not respond to optimal treatment within 2 days), G3 nausea (did not respond to optimal treatment within 7days), or Hy's law or protocol-specified toxicities related to liver function test results or amylase and/or lipase elevations; or any \>=G3 possibly related non-hematological AE, which occurred during first 2 cycles (as specified in protocol).

Analysis population: The Dose-Determining Set (DDS) consists of all participants from the Safety Set (received at least one dose of GEN1029 and analyzed according to the actual trial treatment received) who either received between 80% and 125% of the planned dose and completed the DLT observation period (Days 1-28), or experienced a DLT during Cycle 1.

Groups in this outcome

Biweekly Regimen (GEN1029 0.1 mg/kg)

Participants received 0.1 mg/kg of GEN1029 every 2 weeks (Q2W) until the end of treatment.

Biweekly Regimen (GEN1029 0.2 mg/kg)

Participants received 0.2 mg/kg of GEN1029 Q2W until the end of treatment.

Biweekly Regimen (GEN1029 0.3 mg/kg)

Participants received 0.3 mg/kg of GEN1029 Q2W until the end of treatment.

Biweekly Regimen (GEN1029 1.0 mg/kg)

Participants received 1.0 mg/kg of GEN1029 Q2W until the end of treatment.

Biweekly Regimen (GEN1029 2.0 mg/kg)

Participants received 2.0 mg/kg of GEN1029 Q2W until the end of treatment.

Biweekly Regimen (GEN1029 3.0 mg/kg)

Participants received 3.0 mg/kg of GEN1029 Q2W until the end of treatment.

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
Biweekly Regimen (GEN1029 0.1 mg/kg)	10
Biweekly Regimen (GEN1029 0.2 mg/kg)	6
Biweekly Regimen (GEN1029 0.3 mg/kg)	3
Biweekly Regimen (GEN1029 1.0 mg/kg)	10
Biweekly Regimen (GEN1029 2.0 mg/kg)	7
Biweekly Regimen (GEN1029 3.0 mg/kg)	5

Reported measurements

Source class 1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Biweekly Regimen (GEN1029 0.1 mg/kg)	0	Not reported	Not reported	Not reported	Not reported
Biweekly Regimen (GEN1029 0.2 mg/kg)	1	Not reported	Not reported	Not reported	Not reported
Biweekly Regimen (GEN1029 0.3 mg/kg)	0	Not reported	Not reported	Not reported	Not reported
Biweekly Regimen (GEN1029 1.0 mg/kg)	3	Not reported	Not reported	Not reported	Not reported
Biweekly Regimen (GEN1029 2.0 mg/kg)	3	Not reported	Not reported	Not reported	Not reported
Biweekly Regimen (GEN1029 3.0 mg/kg)	2	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
group Id
OG002
value
0
group Id
OG003
value
3
group Id
OG004
value
3
group Id
OG005
value
2

denoms

counts
group Id
OG000
value
10
group Id
OG001
value
6
group Id
OG002
value
3
group Id
OG003
value
10
group Id
OG004
value
7
group Id
OG005
value
5
units
Participants

description

groups

description
Participants received 0.1 mg/kg of GEN1029 every 2 weeks (Q2W) until the end of treatment.
id
OG000
title
Biweekly Regimen (GEN1029 0.1 mg/kg)
description
Participants received 0.2 mg/kg of GEN1029 Q2W until the end of treatment.
id
OG001
title
Biweekly Regimen (GEN1029 0.2 mg/kg)
description
Participants received 0.3 mg/kg of GEN1029 Q2W until the end of treatment.
id
OG002
title
Biweekly Regimen (GEN1029 0.3 mg/kg)
description
Participants received 1.0 mg/kg of GEN1029 Q2W until the end of treatment.
id
OG003
title
Biweekly Regimen (GEN1029 1.0 mg/kg)
description
Participants received 2.0 mg/kg of GEN1029 Q2W until the end of treatment.
id
OG004
title
Biweekly Regimen (GEN1029 2.0 mg/kg)
description
Participants received 3.0 mg/kg of GEN1029 Q2W until the end of treatment.
id
OG005
title
Biweekly Regimen (GEN1029 3.0 mg/kg)

param Type

COUNT_OF_PARTICIPANTS

population Description

The Dose-Determining Set (DDS) consists of all participants from the Safety Set (received at least one dose of GEN1029 and analyzed according to the actual trial treatment received) who either received between 80% and 125% of the planned dose and completed the DLT observation period (Days 1-28), or experienced a DLT during Cycle 1.

reporting Status

POSTED

time Frame

From Day 1 to 28 days after the first dose of study drug

title

Number of Participants With Dose Limiting Toxicities (DLTs)

type

PRIMARY

unit Of Measure

Participants

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

Preserved source evidence · Not medical advice