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NCT05047536 · OUTCOME

Objective Response (ORR) Following KZR-261

KZR-261 in Subjects With Advanced Solid Malignancies · Source last updated 2025-12-19

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

Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
20 months

What was measured

The objective response following KZR-261 defined as a best overall response of Complete Response (CR) or Partial Response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. A CR is defined as the disappearance of all target lesions and a PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of longest lesion diameters.

Analysis population: The Response Evaluable Population is defined as all participants who received at least 1 dose of study treatment (KZR-261) and who have a baseline and at least 1 post-baseline anti-tumor response assessment.

Groups in this outcome

Dose 1

Participants received 1.8 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.

Dose 2

Participants received 3.6 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.

Dose 3

Participants received 7.2 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.

Dose 4

Participants received 12 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.

Dose 5

Participants received 18 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.

Dose 6

Participants received 27 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.

Dose 7

Participants received 40 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.

Dose 8

Participants received 60 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.

Dose 9

Participants received 80 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.

Melanoma Expansion Cohort

Participants received 60 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Dose 12
Dose 22
Dose 32
Dose 45
Dose 54
Dose 65
Dose 75
Dose 814
Dose 96
Melanoma Expansion Cohort6

Reported measurements

Source class 1
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose 10Not reportedNot reportedNot reportedNot reported
Dose 20Not reportedNot reportedNot reportedNot reported
Dose 30Not reportedNot reportedNot reportedNot reported
Dose 40Not reportedNot reportedNot reportedNot reported
Dose 50Not reportedNot reportedNot reportedNot reported
Dose 60Not reportedNot reportedNot reportedNot reported
Dose 70Not reportedNot reportedNot reportedNot reported
Dose 80Not reportedNot reportedNot reportedNot reported
Dose 90Not reportedNot reportedNot reportedNot reported
Melanoma Expansion Cohort0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      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
      7. group Id
        OG006
        value
        0
      8. group Id
        OG007
        value
        0
      9. group Id
        OG008
        value
        0
      10. group Id
        OG009
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      2
    2. group Id
      OG001
      value
      2
    3. group Id
      OG002
      value
      2
    4. group Id
      OG003
      value
      5
    5. group Id
      OG004
      value
      4
    6. group Id
      OG005
      value
      5
    7. group Id
      OG006
      value
      5
    8. group Id
      OG007
      value
      14
    9. group Id
      OG008
      value
      6
    10. group Id
      OG009
      value
      6
    units
    Participants
description
The objective response following KZR-261 defined as a best overall response of Complete Response (CR) or Partial Response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. A CR is defined as the disappearance of all target lesions and a PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of longest lesion diameters.
groups
  1. description
    Participants received 1.8 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
    id
    OG000
    title
    Dose 1
  2. description
    Participants received 3.6 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
    id
    OG001
    title
    Dose 2
  3. description
    Participants received 7.2 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
    id
    OG002
    title
    Dose 3
  4. description
    Participants received 12 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
    id
    OG003
    title
    Dose 4
  5. description
    Participants received 18 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
    id
    OG004
    title
    Dose 5
  6. description
    Participants received 27 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
    id
    OG005
    title
    Dose 6
  7. description
    Participants received 40 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
    id
    OG006
    title
    Dose 7
  8. description
    Participants received 60 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
    id
    OG007
    title
    Dose 8
  9. description
    Participants received 80 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
    id
    OG008
    title
    Dose 9
  10. description
    Participants received 60 mg/m\^2 of KZR-261. Participants received 3 doses in a 28-day cycle as an intravenous (IV) infusion for up to six cycles.
    id
    OG009
    title
    Melanoma Expansion Cohort
param Type
NUMBER
population Description
The Response Evaluable Population is defined as all participants who received at least 1 dose of study treatment (KZR-261) and who have a baseline and at least 1 post-baseline anti-tumor response assessment.
reporting Status
POSTED
time Frame
20 months
title
Objective Response (ORR) Following KZR-261
type
SECONDARY
unit Of Measure
participants

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Preserved source evidence · Not medical advice