A Phase 2, multicenter, open-label study of DS-8201a in subjects with HER2-expressing advanced colorectal cancer

Phase 1

• Conditions: Human epidermal growth factor receptor 2 (HER2)- expressing advanced colorectal cancer; MedDRA version: 20.0 Level: LLT Classification code 10010029 Term: Colorectal cancer NOS System Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2017-003466-28-GB
• Lead Sponsor: Daiichi Sankyo Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-03-05
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 90

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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

- Has a medical history of myocardial infarction within 6 months, symptomatic congestive heart failure
- Has a history of (non-infectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening
- Has spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring therapy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine the objective response rate (ORR) of DS-8201a in HER2 - positive advanced metastatic colorectal cancer patients. (Cohort A).;<br> Secondary Objective: •To evaluate duration of response (DoR), disease control rate (DCR), progression-free survival (PFS), and overall survival (OS). ORR assessed by the investigator is also evaluated.<br> •To evaluate the safety of DS-8201a<br> •To determine the pharmacokinetics (PK) of DS-8201a<br> ;Primary end point(s): Objective response rate (ORR) per imaging assessment - Percentage of participants with objective response per independent central imaging facility review based on Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1;Timepoint(s) of evaluation of this end point: every 6 weeks

Secondary Outcome Measures

Name	Time	Method
<br> Secondary end point(s): ·Progression-free survival<br> ·Overall survival <br> ·Duration of response <br> ·Disease control rate (DCR)<br> ·ORR assessed by the investigator based on RECIST version 1.1 <br> <br> The following apply to categories; DS-8201a, total anti-HER2 antibody, and MAAA-1181a<br> ·Maximum serum/plasma concentration (Cmax) <br> · Time to Cmax (Tmax)<br> ·Area under the concentration-time curve (AUC) <br> ·AUC from the time of dosing until day 21 (AUC0-21d)<br> ;Timepoint(s) of evaluation of this end point: every 6 weeks for efficacy, OS for until death or last contact with subject