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NCT05551117 · OUTCOME

Number of Participants Who Develop Anti-drug Antibodies (ADA)

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
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
Every 4 weeks throughout the study, average duration of participation was 10 months.

What was measured

Participant specimens were evaluated for the presence of ADA beginning a baseline and throughout the study. If at any time during the study, the results show evidence of ADA, they were counted as ADA positive. There was no time-to- event analysis nor by visit analysis of the data.

Analysis population: The ADA Evaluable Population was used for this analysis. Participants in the control arm did not receive MGC018.

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)90
Part 1: MGC018 2.7 mg (Arm B)86
Part 1: Control Arm0
Part 24

Reported measurements

Positive ADA at baseline
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: MGC018 2.0 mg (Arm A)0Not reportedNot reportedNot reportedNot reported
Part 1: MGC018 2.7 mg (Arm B)0Not reportedNot reportedNot reportedNot reported
Part 20Not reportedNot reportedNot reportedNot reported
Positive ADA at any time after dosing.
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: MGC018 2.0 mg (Arm A)22Not reportedNot reportedNot reportedNot reported
Part 1: MGC018 2.7 mg (Arm B)16Not reportedNot reportedNot reportedNot reported
Part 20Not 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
        OG003
        value
        0
    title
    Positive ADA at baseline
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        22
      2. group Id
        OG001
        value
        16
      3. group Id
        OG003
        value
        0
    title
    Positive ADA at any time after dosing.
denoms
  1. counts
    1. group Id
      OG000
      value
      90
    2. group Id
      OG001
      value
      86
    3. group Id
      OG002
      value
      0
    4. group Id
      OG003
      value
      4
    units
    Participants
description
Participant specimens were evaluated for the presence of ADA beginning a baseline and throughout the study. If at any time during the study, the results show evidence of ADA, they were counted as ADA positive. There was no time-to- event analysis nor by visit analysis of the data.
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
NUMBER
population Description
The ADA Evaluable Population was used for this analysis. Participants in the control arm did not receive MGC018.
reporting Status
POSTED
time Frame
Every 4 weeks throughout the study, average duration of participation was 10 months.
title
Number of Participants Who Develop Anti-drug Antibodies (ADA)
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice