Clinical Trials /

DS-8201a in Human Epidermal Growth Factor Receptor2 (HER2)-Expressing Colorectal Cancer

NCT03384940

Description:

The main objective of this study is to test the safety and effectiveness of DS-8201a for participants with HER2-expressing advanced colorectal cancer.

Related Conditions:
  • Colorectal Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: DS-8201a in Human Epidermal Growth Factor Receptor2 (HER2)-Expressing Colorectal Cancer
  • Official Title: A Phase 2, Multicenter, Open-label Study of DS-8201a in Subjects With HER2-expressing Advanced Colorectal Cancer

Clinical Trial IDs

  • ORG STUDY ID: DS8201-A-J203
  • SECONDARY ID: 2017-003466-28
  • NCT ID: NCT03384940

Conditions

  • Colorectal Neoplasm

Interventions

DrugSynonymsArms
DS-8201aExperimental productDS-8201a Cohort A

Purpose

The main objective of this study is to test the safety and effectiveness of DS-8201a for participants with HER2-expressing advanced colorectal cancer.

Detailed Description

      At study start, only Cohort A is active.

      If, and when, Cohort B and C become active depends on the assessment of benefit and risk
      observed in the program.

      The sponsor will inform the investigators if, and when, Cohort B and C are active.
    

Trial Arms

NameTypeDescriptionInterventions
DS-8201a Cohort AExperimentalCohort A is comprised of participants with HER2-positive (IHC 3+ or IHC 2+/ISH +) who will receive DS-8201a once every 3 weeks This cohort is active at study start.
  • DS-8201a
DS-8201a Cohort BExperimentalCohort B is comprised of participants with HER2 IHC 2+/ISH - who will receive DS-8201a once every 3 weeks The sponsor will inform investigators if, and when, this cohort becomes active.
  • DS-8201a
DS-8201a Cohort CExperimentalCohort C is comprised of participants with HER2 IHC 1+ who will receive DS-8201a once every 3 weeks The sponsor will inform investigators if, and when, this cohort becomes active.
  • DS-8201a

Eligibility Criteria

        Inclusion Criteria:

          -  Has pathologically documented unresectable, recurrent, or metastatic colorectal
             adenocarcinoma (until sponsor's notification to the study sites, subject must be a
             RAS/BRAF wild-type cancer)

          -  Has received at least 2 prior regimens of standard treatment

          -  Has measurable disease assessed by the investigator based on RECIST version 1.1.

          -  Has an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1

        Exclusion Criteria:

          -  Has a medical history of myocardial infarction within 6 months, symptomatic congestive
             heart failure

          -  Has had clinically significant lung disease requiring systemic corticosteroid
             treatment within the last 6 months or is suspected of having such a disease based on
             imaging in the screening period

          -  Has spinal cord compression or clinically active central nervous system metastases,
             defined as untreated and symptomatic, or requiring therapy
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Objective response rate (ORR) per imaging assessment
Time Frame:from Cycle 1 Day 1 through disease progression (within 18 months)
Safety Issue:
Description:Percentage of participants with objective response per independent central imaging facility review based on Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1

Secondary Outcome Measures

Measure:Progression-free survival
Time Frame:within 18 months
Safety Issue:
Description:Percentage of participants still alive without the disease getting worse
Measure:Overall survival (OS)
Time Frame:at 18 months
Safety Issue:
Description:Percentage of participants still alive
Measure:Duration of response
Time Frame:within 18 months
Safety Issue:
Description:Length of time response continued
Measure:Disease control rate (DCR)
Time Frame:within 18 months
Safety Issue:
Description:Percentage of participants with controlled disease
Measure:ORR assessed by the investigator based on RECIST version 1.1
Time Frame:within 18 months
Safety Issue:
Description:Percentage of participants with objective response as assessed by the investigator, based on RECIST version 1.1
Measure:Maximum serum/plasma concentration (Cmax)
Time Frame:within 21 days
Safety Issue:
Description:Categories: DS-8201a, total anti-HER2 antibody, and MAAA-1181a
Measure:Time to Cmax (Tmax)
Time Frame:within 21 days
Safety Issue:
Description:Categories: DS-8201a, total anti-HER2 antibody, and MAAA-1181a
Measure:Area under the concentration-time curve (AUC) from dosing until the last quantifiable concentration (AUClast)
Time Frame:within 21 days
Safety Issue:
Description:Categories: DS-8201a, total anti-HER2 antibody, and MAAA-1181a
Measure:AUC from the time of dosing until day 21 (AUC0-21d)
Time Frame:at Day 21
Safety Issue:
Description:Categories: DS-8201a, total anti-HER2 antibody, and MAAA-1181a

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Daiichi Sankyo Co., Ltd.

Trial Keywords

  • Oncology
  • HER2
  • Colorectal cancer
  • Antibody drug conjugate
  • ADC

Last Updated

January 24, 2018