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NCT02988817 · OUTCOME

Number of Participants With >= Grade 3 TEAEs as Assessed by National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03

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 (maximum observed duration)

What was measured

Number of participants with TEAEs of \>= Grade 3 as assessed by NCI-CTCAE v4.03 is reported. The NCI-CTCAE is a descriptive terminology is used for AE reporting. The NCI-CTCAE v4.03 displays Grades 1 through 5 with unique clinical descriptions of severity for each AE, based on this general guideline: Grade 1 as mild AE, Grade 2 as moderate AE, Grade 3 as severe AE, Grade 4 as life-threatening or disabling AE, and Grade 5 as death. If a participant reported multiple severity grades for an AE, only the maximum grade was used.

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 1Q3W0Not reportedNot reportedNot reportedNot reported
Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W2Not reportedNot reportedNot reportedNot reported
Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W7Not reportedNot reportedNot reportedNot reported
Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W9Not reportedNot reportedNot reportedNot reported
Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W3Not reportedNot reportedNot reportedNot reported
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W1Not 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 3Q4W3Not reportedNot reportedNot reportedNot reported
Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W3Not reportedNot reportedNot reportedNot reported
Expansion Part Cohort 1: Enapotamab Vedotin 2.2 mg/kg 1Q3W15Not reportedNot reportedNot reportedNot reported
Expansion Part Cohort 3: Enapotamab Vedotin 2.2 mg/kg 1Q3W6Not reportedNot reportedNot reportedNot reported
Expansion Part Cohort 4: Enapotamab Vedotin 2.2 mg/kg 1Q3W18Not reportedNot reportedNot reportedNot reported
Expansion Part Cohort 5: Enapotamab Vedotin 2.2 mg/kg 1Q3W16Not reportedNot reportedNot reportedNot reported
Expansion Part Cohort 6: Enapotamab Vedotin 1.0 mg/kg 3Q4W21Not reportedNot reportedNot reportedNot reported
Expansion Part Cohort 7: Enapotamab Vedotin 2.2 mg/kg 1Q3W15Not reportedNot reportedNot reportedNot reported
Expansion Part Cohort 2: Enapotamab Vedotin 2.2 mg/kg 1Q3W40Not reportedNot reportedNot reportedNot reported
Expansion Part Cohort 2: Enapotamab Vedotin 1.8 mg/kg 1Q3W14Not reportedNot reportedNot reportedNot reported
Expansion Part Cohort 8: Enapotamab Vedotin 1.0 mg/kg 3Q4W13Not 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
        2
      5. group Id
        OG004
        value
        7
      6. group Id
        OG005
        value
        9
      7. group Id
        OG006
        value
        3
      8. group Id
        OG007
        value
        1
      9. group Id
        OG008
        value
        0
      10. group Id
        OG009
        value
        3
      11. group Id
        OG010
        value
        3
      12. group Id
        OG011
        value
        15
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
Number of participants with TEAEs of \>= Grade 3 as assessed by NCI-CTCAE v4.03 is reported. The NCI-CTCAE is a descriptive terminology is used for AE reporting. The NCI-CTCAE v4.03 displays Grades 1 through 5 with unique clinical descriptions of severity for each AE, based on this general guideline: Grade 1 as mild AE, Grade 2 as moderate AE, Grade 3 as severe AE, Grade 4 as life-threatening or disabling AE, and Grade 5 as death. If a participant reported multiple severity grades for an AE, only the maximum grade was used.
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 (maximum observed duration)
title
Number of Participants With >= Grade 3 TEAEs as Assessed by National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice