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NCT02564900 · OUTCOME

Disease Control Rate (DCR) Following Treatment With DS-8201a in Participants With Advanced Solid Malignant Tumors (Dose Escalation and Dose Expansion Phases)

Study of DS-8201a in Subjects With Advanced Solid Malignant Tumors · Source last updated 2024-01-22

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

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
From 6 months postdose of last participant up to 3 years 5 months

What was measured

Disease control rate (DCR) by independent central review was calculated as the proportion of participants demonstrating complete response (CR), partial response (PR), or stable disease (SD) for a minimum of 6 weeks (±1week) from the first dosing date. CR was defined as a disappearance of all target lesions, PR as at least a 30% decrease in the sum of diameters of target lesions, and stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of diameters of target lesions. HER2-positive other solid tumors included 8 participants with salivary/submandibular/parotid gland, 2 breast with HER2-mutation, 2 endometrial, 2 esophageal, 2 Paget's disease, 1 cholangiocarcinoma, 1 extraskeletal myxoide chondrosarcoma, 1 gallbladder, 1 pancreatic, 1 small intestine, 1 uterine cervix, and 1 participant who received 5.4 mg/kg with HER2-low gastric/GEJ cancer.

Analysis population: DCR was assessed in the Intent-to-Treat Analysis Set.

Groups in this outcome

Dose Escalation: Cohort 1, 0.8 mg/kg

Participants in Cohort 1 received an intravenous 0.8 mg/kg dose of DS-8201a (FL-DP1).

Dose Escalation: Cohort 2, 1.6 mg/kg

Participants in Cohort 2 received an intravenous 1.6 mg/kg dose of DS-8201a (FL-DP1).

Dose Escalation: Cohort 3, 3.2 mg/kg

Participants in Cohort 3 received an intravenous 3.2 mg/kg dose of DS-8201a (FL-DP1).

Dose Escalation: Cohort 4, 5.4 mg/kg

Participants in Cohort 4 received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).

Dose Escalation: Cohort 5, 6.4 mg/kg

Participants in Cohort 5 received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).

Dose Escalation: Cohort 6, 8.0 mg/kg

Participants in Cohort 6 received an intravenous 8.0 mg/kg dose of DS-8201a (FL-DP1).

Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg

Participants with HER2-overexpressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).

Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg

Participants with HER2-overexpressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).

Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg

Participants with HER2-low expressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).

Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg

Participants with HER2-low expressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).

Dose Expansion: HER2-overexpressing Gastric or GEJ, 5.4 mg/kg

Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).

Dose Expansion: HER2-overexpressing Gastric or GEJ, 6.4 mg/kg

Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).

Dose Expansion: HER2-expressing NSCLC Tumors

Participants with HER2-expressing NSCLC tumors received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).

Dose Expansion: HER2-expressing Colorectal Tumors

Participants with HER2-expressing colorectal tumors received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).

Dose Expansion: HER2-expressing Other Solid Tumors

Participants with any other HER2-expressing solid tumor other than breast or gastric or any tumor with HER2 mutation received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).

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: Cohort 1, 0.8 mg/kg3
Dose Escalation: Cohort 2, 1.6 mg/kg3
Dose Escalation: Cohort 3, 3.2 mg/kg3
Dose Escalation: Cohort 4, 5.4 mg/kg6
Dose Escalation: Cohort 5, 6.4 mg/kg6
Dose Escalation: Cohort 6, 8.0 mg/kg6
Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg51
Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg67
Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg21
Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg33
Dose Expansion: HER2-overexpressing Gastric or GEJ, 5.4 mg/kg19
Dose Expansion: HER2-overexpressing Gastric or GEJ, 6.4 mg/kg25
Dose Expansion: HER2-expressing NSCLC Tumors18
Dose Expansion: HER2-expressing Colorectal Tumors20
Dose Expansion: HER2-expressing Other Solid Tumors23

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Dose Escalation: Cohort 1, 0.8 mg/kg100.0Not reported29.2100.0Not reported
Dose Escalation: Cohort 2, 1.6 mg/kg100.0Not reported29.2100.0Not reported
Dose Escalation: Cohort 3, 3.2 mg/kg66.7Not reported9.499.2Not reported
Dose Escalation: Cohort 4, 5.4 mg/kg100.0Not reported54.1100.0Not reported
Dose Escalation: Cohort 5, 6.4 mg/kg100.0Not reported54.1100.0Not reported
Dose Escalation: Cohort 6, 8.0 mg/kg100.0Not reported54.1100.0Not reported
Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg88.2Not reported76.195.6Not reported
Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg95.5Not reported87.599.1Not reported
Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg85.7Not reported63.797.0Not reported
Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg87.9Not reported71.896.6Not reported
Dose Expansion: HER2-overexpressing Gastric or GEJ, 5.4 mg/kg78.9Not reported54.493.9Not reported
Dose Expansion: HER2-overexpressing Gastric or GEJ, 6.4 mg/kg88.0Not reported68.897.5Not reported
Dose Expansion: HER2-expressing NSCLC Tumors83.3Not reported58.696.4Not reported
Dose Expansion: HER2-expressing Colorectal Tumors80.0Not reported56.394.3Not reported
Dose Expansion: HER2-expressing Other Solid Tumors82.6Not reported61.295.0Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        29.2
        upper Limit
        100.0
        value
        100.0
      2. group Id
        OG001
        lower Limit
        29.2
        upper Limit
        100.0
        value
        100.0
      3. group Id
        OG002
        lower Limit
        9.4
        upper Limit
        99.2
        value
        66.7
      4. group Id
        OG003
        lower Limit
        54.1
        upper Limit
        100.0
        value
        100.0
      5. group Id
        OG004
        lower Limit
        54.1
        upper Limit
        100.0
        value
        100.0
      6. group Id
        OG005
        lower Limit
        54.1
        upper Limit
        100.0
        value
        100.0
      7. group Id
        OG006
        lower Limit
        76.1
        upper Limit
        95.6
        value
        88.2
      8. group Id
        OG007
        lower Limit
        87.5
        upper Limit
        99.1
        value
        95.5
      9. group Id
        OG008
        lower Limit
        63.7
        upper Limit
        97.0
        value
        85.7
      10. group Id
        OG009
        lower Limit
        71.8
        upper Limit
        96.6
        value
        87.9
      11. group Id
        OG010
        lower Limit
        54.4
        upper Limit
        93.9
        value
        78.9
      12. group Id
        OG011
        lower Limit
        68.8
        upper Limit
        97.5
        value
        88.0
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      3
    3. group Id
      OG002
      value
      3
    4. group Id
      OG003
      value
      6
    5. group Id
      OG004
      value
      6
    6. group Id
      OG005
      value
      6
    7. group Id
      OG006
      value
      51
    8. group Id
      OG007
      value
      67
    9. group Id
      OG008
      value
      21
    10. group Id
      OG009
      value
      33
    11. group Id
      OG010
      value
      19
    12. group Id
      OG011
      value
      25
    units
    Participants
description
Disease control rate (DCR) by independent central review was calculated as the proportion of participants demonstrating complete response (CR), partial response (PR), or stable disease (SD) for a minimum of 6 weeks (±1week) from the first dosing date. CR was defined as a disappearance of all target lesions, PR as at least a 30% decrease in the sum of diameters of target lesions, and stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of diameters of target lesions. HER2-positive other solid tumors included 8 participants with salivary/submandibular/parotid gland, 2 breast with HER2-mutation, 2 endometrial, 2 esophageal, 2 Paget's disease, 1 cholangiocarcinoma, 1 extraskeletal myxoide chondrosarcoma, 1 gallbladder, 1 pancreatic, 1 small intestine, 1 uterine cervix, and 1 participant who received 5.4 mg/kg with HER2-low gastric/GEJ cancer.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants in Cohort 1 received an intravenous 0.8 mg/kg dose of DS-8201a (FL-DP1).
    id
    OG000
    title
    Dose Escalation: Cohort 1, 0.8 mg/kg
  2. description
    Participants in Cohort 2 received an intravenous 1.6 mg/kg dose of DS-8201a (FL-DP1).
    id
    OG001
    title
    Dose Escalation: Cohort 2, 1.6 mg/kg
  3. description
    Participants in Cohort 3 received an intravenous 3.2 mg/kg dose of DS-8201a (FL-DP1).
    id
    OG002
    title
    Dose Escalation: Cohort 3, 3.2 mg/kg
  4. description
    Participants in Cohort 4 received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
    id
    OG003
    title
    Dose Escalation: Cohort 4, 5.4 mg/kg
  5. description
    Participants in Cohort 5 received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
    id
    OG004
    title
    Dose Escalation: Cohort 5, 6.4 mg/kg
  6. description
    Participants in Cohort 6 received an intravenous 8.0 mg/kg dose of DS-8201a (FL-DP1).
    id
    OG005
    title
    Dose Escalation: Cohort 6, 8.0 mg/kg
  7. description
    Participants with HER2-overexpressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
    id
    OG006
    title
    Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg
  8. description
    Participants with HER2-overexpressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
    id
    OG007
    title
    Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg
  9. description
    Participants with HER2-low expressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
    id
    OG008
    title
    Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg
  10. description
    Participants with HER2-low expressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
    id
    OG009
    title
    Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg
  11. description
    Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
    id
    OG010
    title
    Dose Expansion: HER2-overexpressing Gastric or GEJ, 5.4 mg/kg
  12. description
    Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
    id
    OG011
    title
    Dose Expansion: HER2-overexpressing Gastric or GEJ, 6.4 mg/kg
param Type
NUMBER
population Description
DCR was assessed in the Intent-to-Treat Analysis Set.
reporting Status
POSTED
time Frame
From 6 months postdose of last participant up to 3 years 5 months
title
Disease Control Rate (DCR) Following Treatment With DS-8201a in Participants With Advanced Solid Malignant Tumors (Dose Escalation and Dose Expansion Phases)
type
SECONDARY
unit Of Measure
percentage of participants

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Preserved source evidence · Not medical advice