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NCT05047536 · OUTCOME

Number and Percentage of Participants Experiencing Dose-limiting Toxicities

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
28 days

What was measured

Number and percentage of participants experiencing dose-limiting toxicities (DLT) collected from start of enrollment through the first 28 days of Cycle 1 as assessed by CTCAE v5.0 (Part 1).

Analysis population: The DLT Evaluable Population consists of all participants who either met the following minimal exposure criteria and have sufficient safety evaluations without having a DLT, or have experienced a DLT during the DLT assessment period. Participants who did not experience a DLT in Dose Escalation must have received all of their scheduled doses (Days 1, 8, and 15) during the DLT assessment period with completed follow-up data available through 28 days of Cycle 1 to be DLT-assessable.

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.

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 56
Dose 65
Dose 75
Dose 814
Dose 95

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 41Not reportedNot reportedNot reportedNot reported
Dose 51Not reportedNot reportedNot reportedNot reported
Dose 60Not reportedNot reportedNot reportedNot reported
Dose 70Not reportedNot reportedNot reportedNot reported
Dose 80Not reportedNot reportedNot reportedNot reported
Dose 91Not 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
        1
      5. group Id
        OG004
        value
        1
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        0
      8. group Id
        OG007
        value
        0
      9. group Id
        OG008
        value
        1
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
      6
    6. group Id
      OG005
      value
      5
    7. group Id
      OG006
      value
      5
    8. group Id
      OG007
      value
      14
    9. group Id
      OG008
      value
      5
    units
    Participants
description
Number and percentage of participants experiencing dose-limiting toxicities (DLT) collected from start of enrollment through the first 28 days of Cycle 1 as assessed by CTCAE v5.0 (Part 1).
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
param Type
COUNT_OF_PARTICIPANTS
population Description
The DLT Evaluable Population consists of all participants who either met the following minimal exposure criteria and have sufficient safety evaluations without having a DLT, or have experienced a DLT during the DLT assessment period. Participants who did not experience a DLT in Dose Escalation must have received all of their scheduled doses (Days 1, 8, and 15) during the DLT assessment period with completed follow-up data available through 28 days of Cycle 1 to be DLT-assessable.
reporting Status
POSTED
time Frame
28 days
title
Number and Percentage of Participants Experiencing Dose-limiting Toxicities
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice