DS-8201a in Human Epidermal Growth Factor Receptor2 (HER2)-Expressing Colorectal Cancer (DESTINY-CRC01)

Daiichi Sankyo

Status and phase: Completed; Phase 2

Conditions: Colorectal Neoplasm

Treatments: Drug: DS-8201a

Study type: Interventional

Funder types: Industry

Identifiers

NCT03384940

DS8201-A-J203

173808 (Registry Identifier)

2017-003466-28 (EudraCT Number)

DESTINY-C01 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 86 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 a medical history of clinically significant lung disease
• Has spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring therapy

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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86 participants in 3 patient groups

DS-8201a Cohort A

Experimental group

Description:

Cohort A is comprised of participants with HER2-positive (IHC 3+ or IHC 2+/ISH +) who will receive DS-8201a once every 3 weeks

Treatment:

Drug: DS-8201a

DS-8201a Cohort B

Experimental group

Description:

Cohort B is comprised of participants with HER2 IHC 2+/ISH - who will receive DS-8201a once every 3 weeks

Treatment:

Drug: DS-8201a

DS-8201a Cohort C

Experimental group

Description:

Cohort C is comprised of participants with HER2 IHC 1+ who will receive DS-8201a once every 3 weeks

Treatment:

Drug: DS-8201a