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NCT02988817 · OUTCOME

Number of Participants With Antidrug Antibodies (ADAs) Confirmed Positive to Enapotamab Vedotin

Enapotamab Vedotin (HuMax-AXL-ADC) Safety Study in Patients With Solid Tumors · Source last updated 2023-08-01

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
Day 1 through Day 1130 (Dose-escalation part: Predose of Day 1 of Cycles 1 to 12, end of treatment [EOT], and 30 days after last study drug; Expansion part: Predose on Day 1 of Cycles 1 to 5, then every fourth cycle until PD)

What was measured

The ADA assessment was performed according to a tiered approach. First samples were screened for an ADA response; positively screened samples were analyzed in a confirmation method. Subsequently confirmed positive samples were analyzed for titre and the presence of neutralizing antibodies. Number of participants with ADA confirmed positive to enapotamab vedotin is reported.

Analysis population: The safety set included all participants who received at least 1 dose of enapotamab vedotin and had at least one valid post-baseline safety assessment. Participants were classified according to first dose received.

Groups in this outcome

Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W

Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.3 mg/kg 1Q3W until the end of treatment.

Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W

Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 1Q3W until the end of treatment.

Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W

Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 1Q3W until the end of treatment.

Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W

Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.5 mg/kg 1Q3W until the end of treatment.

Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W

Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.0 mg/kg 1Q3W until the end of treatment.

Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W

Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.

Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W

Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.4 mg/kg 1Q3W until the end of treatment.

Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W

Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 3Q4W until the end of treatment.

Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W

Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.8 mg/kg 3Q4W until the end of treatment.

Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W

Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.

Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W

Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.2 mg/kg 3Q4W until the end of treatment.

Expansion Part Cohort 1: Enapotamab Vedotin 2.2 mg/kg 1Q3W

Participants with advanced and/or metastatic NSCLC with classical sensitizing EGFR mutations and/or EGFR mutations targeted by third-generation tyrosine kinase inhibitors) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.

Expansion Part Cohort 3: Enapotamab Vedotin 2.2 mg/kg 1Q3W

Participants with advanced and/or metastatic melanoma with BRAF V600 mutation received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.

Expansion Part Cohort 4: Enapotamab Vedotin 2.2 mg/kg 1Q3W

Participants with advanced and/or metastatic melanoma with BRAF V600 wild type received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.

Expansion Part Cohort 5: Enapotamab Vedotin 2.2 mg/kg 1Q3W

Participants with advanced and/or metastatic sarcoma received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.

Expansion Part Cohort 6: Enapotamab Vedotin 1.0 mg/kg 3Q4W

Participants with advanced and/or metastatic solid tumors (excluding NSCLC, melanoma, sarcoma, and ovarian cancer unless having a known AXL gene amplification) received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.

Expansion Part Cohort 7: Enapotamab Vedotin 2.2 mg/kg 1Q3W

Participants with advanced and/or metastatic platinum-resistant ovarian cancer received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.

Expansion Part Cohort 2: Enapotamab Vedotin 2.2 mg/kg 1Q3W

Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.

Expansion Part Cohort 2: Enapotamab Vedotin 1.8 mg/kg 1Q3W

Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 1.8 mg/kg 1Q3W until the end of treatment.

Expansion Part Cohort 8: Enapotamab Vedotin 1.0 mg/kg 3Q4W

Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.

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-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W1
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W1
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W3
Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W3
Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W10
Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W11
Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W3
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W3
Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W3
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W6
Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W3
Expansion Part Cohort 1: Enapotamab Vedotin 2.2 mg/kg 1Q3W22
Expansion Part Cohort 3: Enapotamab Vedotin 2.2 mg/kg 1Q3W16
Expansion Part Cohort 4: Enapotamab Vedotin 2.2 mg/kg 1Q3W25
Expansion Part Cohort 5: Enapotamab Vedotin 2.2 mg/kg 1Q3W25
Expansion Part Cohort 6: Enapotamab Vedotin 1.0 mg/kg 3Q4W44
Expansion Part Cohort 7: Enapotamab Vedotin 2.2 mg/kg 1Q3W25
Expansion Part Cohort 2: Enapotamab Vedotin 2.2 mg/kg 1Q3W56
Expansion Part Cohort 2: Enapotamab Vedotin 1.8 mg/kg 1Q3W20
Expansion Part Cohort 8: Enapotamab Vedotin 1.0 mg/kg 3Q4W26

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W0Not reportedNot reportedNot reportedNot reported
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W0Not reportedNot reportedNot reportedNot reported
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W1Not reportedNot reportedNot reportedNot reported
Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W1Not reportedNot reportedNot reportedNot reported
Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W5Not reportedNot reportedNot reportedNot reported
Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W1Not reportedNot reportedNot reportedNot reported
Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W1Not reportedNot reportedNot reportedNot reported
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W0Not reportedNot reportedNot reportedNot reported
Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W0Not reportedNot reportedNot reportedNot reported
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W2Not reportedNot reportedNot reportedNot reported
Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W0Not reportedNot reportedNot reportedNot reported
Expansion Part Cohort 1: Enapotamab Vedotin 2.2 mg/kg 1Q3W0Not reportedNot reportedNot reportedNot reported
Expansion Part Cohort 3: Enapotamab Vedotin 2.2 mg/kg 1Q3W4Not reportedNot reportedNot reportedNot reported
Expansion Part Cohort 4: Enapotamab Vedotin 2.2 mg/kg 1Q3W1Not reportedNot reportedNot reportedNot reported
Expansion Part Cohort 5: Enapotamab Vedotin 2.2 mg/kg 1Q3W3Not reportedNot reportedNot reportedNot reported
Expansion Part Cohort 6: Enapotamab Vedotin 1.0 mg/kg 3Q4W0Not reportedNot reportedNot reportedNot reported
Expansion Part Cohort 7: Enapotamab Vedotin 2.2 mg/kg 1Q3W7Not reportedNot reportedNot reportedNot reported
Expansion Part Cohort 2: Enapotamab Vedotin 2.2 mg/kg 1Q3W5Not reportedNot reportedNot reportedNot reported
Expansion Part Cohort 2: Enapotamab Vedotin 1.8 mg/kg 1Q3W0Not reportedNot reportedNot reportedNot reported
Expansion Part Cohort 8: Enapotamab Vedotin 1.0 mg/kg 3Q4W0Not 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
        1
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        5
      6. group Id
        OG005
        value
        1
      7. group Id
        OG006
        value
        1
      8. group Id
        OG007
        value
        0
      9. group Id
        OG008
        value
        0
      10. group Id
        OG009
        value
        2
      11. group Id
        OG010
        value
        0
      12. group Id
        OG011
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      1
    2. group Id
      OG001
      value
      1
    3. group Id
      OG002
      value
      3
    4. group Id
      OG003
      value
      3
    5. group Id
      OG004
      value
      10
    6. group Id
      OG005
      value
      11
    7. group Id
      OG006
      value
      3
    8. group Id
      OG007
      value
      3
    9. group Id
      OG008
      value
      3
    10. group Id
      OG009
      value
      6
    11. group Id
      OG010
      value
      3
    12. group Id
      OG011
      value
      22
    units
    Participants
description
The ADA assessment was performed according to a tiered approach. First samples were screened for an ADA response; positively screened samples were analyzed in a confirmation method. Subsequently confirmed positive samples were analyzed for titre and the presence of neutralizing antibodies. Number of participants with ADA confirmed positive to enapotamab vedotin is reported.
groups
  1. description
    Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.3 mg/kg 1Q3W until the end of treatment.
    id
    OG000
    title
    Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W
  2. description
    Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 1Q3W until the end of treatment.
    id
    OG001
    title
    Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W
  3. description
    Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 1Q3W until the end of treatment.
    id
    OG002
    title
    Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W
  4. description
    Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.5 mg/kg 1Q3W until the end of treatment.
    id
    OG003
    title
    Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W
  5. description
    Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.0 mg/kg 1Q3W until the end of treatment.
    id
    OG004
    title
    Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W
  6. description
    Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
    id
    OG005
    title
    Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W
  7. description
    Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.4 mg/kg 1Q3W until the end of treatment.
    id
    OG006
    title
    Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W
  8. description
    Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 3Q4W until the end of treatment.
    id
    OG007
    title
    Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W
  9. description
    Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.8 mg/kg 3Q4W until the end of treatment.
    id
    OG008
    title
    Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W
  10. description
    Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
    id
    OG009
    title
    Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W
  11. description
    Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.2 mg/kg 3Q4W until the end of treatment.
    id
    OG010
    title
    Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W
  12. description
    Participants with advanced and/or metastatic NSCLC with classical sensitizing EGFR mutations and/or EGFR mutations targeted by third-generation tyrosine kinase inhibitors) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
    id
    OG011
    title
    Expansion Part Cohort 1: Enapotamab Vedotin 2.2 mg/kg 1Q3W
param Type
COUNT_OF_PARTICIPANTS
population Description
The safety set included all participants who received at least 1 dose of enapotamab vedotin and had at least one valid post-baseline safety assessment. Participants were classified according to first dose received.
reporting Status
POSTED
time Frame
Day 1 through Day 1130 (Dose-escalation part: Predose of Day 1 of Cycles 1 to 12, end of treatment [EOT], and 30 days after last study drug; Expansion part: Predose on Day 1 of Cycles 1 to 5, then every fourth cycle until PD)
title
Number of Participants With Antidrug Antibodies (ADAs) Confirmed Positive to Enapotamab Vedotin
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice