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NCT03576131 · OUTCOME

Time to Response (TTR) According to RECIST 1.1

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
Not reported
Unit
Not reported
Interval / dispersion
Not reported
Time frame
From Day 1 through 8.8 months (corresponding to maximum observed duration)

What was measured

TTR is defined as the number of days from first dose of study drug to the first documented confirmed CR or PR, which must be subsequently confirmed.

Analysis population: Full analysis set included all participants who received at least one dose of GEN1029 and were analyzed according to the actual trial treatment received. Participants who achieved confirmed OR by the investigator assessment were evaluated for this outcome measure.

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

GroupSource count
Biweekly Regimen (GEN1029 0.1 mg/kg)0
Biweekly Regimen (GEN1029 0.2 mg/kg)0
Biweekly Regimen (GEN1029 0.3 mg/kg)0
Biweekly Regimen (GEN1029 1.0 mg/kg)0
Biweekly Regimen (GEN1029 2.0 mg/kg)0
Biweekly Regimen (GEN1029 3.0 mg/kg)0

Reported measurements

No numerical measurement classes were posted for this outcome. Missing is not zero.

Complete source fields
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    2. group Id
      OG001
      value
      0
    3. group Id
      OG002
      value
      0
    4. group Id
      OG003
      value
      0
    5. group Id
      OG004
      value
      0
    6. group Id
      OG005
      value
      0
    units
    Participants
description
TTR is defined as the number of days from first dose of study drug to the first documented confirmed CR or PR, which must be subsequently confirmed.
groups
  1. 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)
  2. 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)
  3. 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)
  4. 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)
  5. 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)
  6. 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)
population Description
Full analysis set included all participants who received at least one dose of GEN1029 and were analyzed according to the actual trial treatment received. Participants who achieved confirmed OR by the investigator assessment were evaluated for this outcome measure.
reporting Status
POSTED
time Frame
From Day 1 through 8.8 months (corresponding to maximum observed duration)
title
Time to Response (TTR) According to RECIST 1.1
type
SECONDARY

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

Preserved source evidence · Not medical advice