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NCT05551117 · OUTCOME

Part 1: Time to First Symptomatic Skeletal Event (SSE)

A Study of Vobramitamab Duocarmazine in Participants With Metastatic Castration Resistant Prostate Cancer and Other Solid Tumors · Source last updated 2026-02-09

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

Measure
MEAN
Unit
days
Interval / dispersion
Standard Deviation
Time frame
Every 4 weeks throughout the study. Average duration of participation, 10 months.

What was measured

An SSE is defined as any of the following events: new symptomatic pathological fracture, requirement for radiation therapy to relieve bone pain, spinal cord compression, or tumor-related orthopedic surgical intervention. The time to first SSE is defined as the time from the date of randomization to the first occurrence of SSE.

Analysis population: Participants who experienced a symptomatic skeletal event in Part 1 of the study. SSE were not assessed in Part 2, as these participants did not have mCRPC.

Groups in this outcome

Part 1: MGC018 2.0 mg (Arm A)

vobramitamab duocarmazine 2.0 mg/kg, IV, every 4 weeks

Part 1: MGC018 2.7 mg (Arm B)

vobramitamab duocarmazine 2.7 mg/kg, IV, every 4 weeks

Part 1: Control Arm

abiraterone 1000 mg once daily or enzalutamide 160 mg once daily.

Part 2

vobramitamab duocarmazine 2.7 mg.kg, IV, every 4 weeks

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

Analysis denominator · Participants

GroupSource count
Part 1: MGC018 2.0 mg (Arm A)5
Part 1: MGC018 2.7 mg (Arm B)7
Part 1: Control Arm0
Part 20

Reported measurements

Source class 1
Values in days · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part 1: MGC018 2.0 mg (Arm A)3.711.984Not reportedNot reportedNot reported
Part 1: MGC018 2.7 mg (Arm B)2.802.142Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.984
        value
        3.71
      2. group Id
        OG001
        spread
        2.142
        value
        2.80
denoms
  1. counts
    1. group Id
      OG000
      value
      5
    2. group Id
      OG001
      value
      7
    3. group Id
      OG002
      value
      0
    4. group Id
      OG003
      value
      0
    units
    Participants
description
An SSE is defined as any of the following events: new symptomatic pathological fracture, requirement for radiation therapy to relieve bone pain, spinal cord compression, or tumor-related orthopedic surgical intervention. The time to first SSE is defined as the time from the date of randomization to the first occurrence of SSE.
dispersion Type
Standard Deviation
groups
  1. description
    vobramitamab duocarmazine 2.0 mg/kg, IV, every 4 weeks
    id
    OG000
    title
    Part 1: MGC018 2.0 mg (Arm A)
  2. description
    vobramitamab duocarmazine 2.7 mg/kg, IV, every 4 weeks
    id
    OG001
    title
    Part 1: MGC018 2.7 mg (Arm B)
  3. description
    abiraterone 1000 mg once daily or enzalutamide 160 mg once daily.
    id
    OG002
    title
    Part 1: Control Arm
  4. description
    vobramitamab duocarmazine 2.7 mg.kg, IV, every 4 weeks
    id
    OG003
    title
    Part 2
param Type
MEAN
population Description
Participants who experienced a symptomatic skeletal event in Part 1 of the study. SSE were not assessed in Part 2, as these participants did not have mCRPC.
reporting Status
POSTED
time Frame
Every 4 weeks throughout the study. Average duration of participation, 10 months.
title
Part 1: Time to First Symptomatic Skeletal Event (SSE)
type
SECONDARY
unit Of Measure
days

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

Preserved source evidence · Not medical advice