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NCT03621982 · OUTCOME

Number of Participants With Anti-drug Antibody (ADA) Response in Serum

Study of ADCT-301 in Patients With Selected Advanced Solid Tumors · Source last updated 2024-06-13

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
C1D1, from Pre-dose to 336 hr post dose.

What was measured

ADA testing included number of participants with positive pre-dose ADA response, number of participants with post-dose ADA response only, and number of participants with positive ADA response at any time. Collection of ADA was stopped if ADCT-301 administration was discontinued. For participants treated with ADCT-301 in combination with pembrolizumab, unless there was a penultimate observation of positive ADA response, no other collection of ADA data was necessary if ADCT-301 administration was discontinued. Upon consultation with the Sponsor, ADA samples were not collected anymore if ADCT-301 was permanently discontinued and pembrolizumab continues as single agent.

Analysis population: Pharmacodynamic Analysis Set: The pharmacodynamic analysis set consisted of all participants who received study drug and had at least 1 valid pharmacodynamics/biomarker assessment. The data was pooled overall as pre-specified in protocol. Includes participants with available data at each timepoint.

Groups in this outcome

Overall Study

Participants received 20, 30, 45, 60, 80, 100, 125 and 150 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle. Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion)

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

Analysis denominator · Participants

GroupSource count
Overall Study78

Reported measurements

Positive ADA predose
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Overall Study1Not reportedNot reportedNot reportedNot reported
Positive ADA post dose
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Overall Study0Not reportedNot reportedNot reportedNot reported
Positive ADA at any time
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Overall Study1Not reportedNot reportedNot reportedNot reported
Positive ADA before and after dose
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Overall Study1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Positive ADA predose
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Positive ADA post dose
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Positive ADA at any time
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Positive ADA before and after dose
denoms
  1. counts
    1. group Id
      OG000
      value
      78
    units
    Participants
description
ADA testing included number of participants with positive pre-dose ADA response, number of participants with post-dose ADA response only, and number of participants with positive ADA response at any time. Collection of ADA was stopped if ADCT-301 administration was discontinued. For participants treated with ADCT-301 in combination with pembrolizumab, unless there was a penultimate observation of positive ADA response, no other collection of ADA data was necessary if ADCT-301 administration was discontinued. Upon consultation with the Sponsor, ADA samples were not collected anymore if ADCT-301 was permanently discontinued and pembrolizumab continues as single agent.
groups
  1. description
    Participants received 20, 30, 45, 60, 80, 100, 125 and 150 µg/kg ADCT-301 Q3W, IV infusion on Day 1 of each 21-day cycle. Pembrolizumab was administered as a 30 minute IV infusion at a fixed dose of 200 mg (starting 1 hour after the end of the ADCT-301 infusion)
    id
    OG000
    title
    Overall Study
param Type
COUNT_OF_PARTICIPANTS
population Description
Pharmacodynamic Analysis Set: The pharmacodynamic analysis set consisted of all participants who received study drug and had at least 1 valid pharmacodynamics/biomarker assessment. The data was pooled overall as pre-specified in protocol. Includes participants with available data at each timepoint.
reporting Status
POSTED
time Frame
C1D1, from Pre-dose to 336 hr post dose.
title
Number of Participants With Anti-drug Antibody (ADA) Response in Serum
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice