Safety, Tolerability, and Pharmacokinetic (PK) Study of DHES0815A in Participants With Human Epidermal Growth Factor Receptor (HER)2-Positive Breast Cancer

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-17

Study Completion Date

2021-07-16

Brief Summary

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This first-in-human, Phase 1, open-label, multicenter, dose-escalation study will evaluate the safety, tolerability, and PK of DHES0815A as a single agent in participants with advanced and/or metastatic HER2-positive breast cancer for whom established treatment has proven ineffective or intolerable or is unavailable. The study may include a dose-expansion cohort (based on an ongoing assessment of the totality of data obtained in this study) to further assess safety, tolerability, PK, and preliminary anti-tumor activity.

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Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dose Escalation Cohort: DHES0815A

Participants will receive DHES0815A in escalating doses in the dose-escalation cohort of the study. Participants will receive additional infusions of DHES0815A on Day 1 of subsequent cycles provided that they meet the protocol specified criteria for acceptable toxicity and ongoing clinical benefit.

Group Type EXPERIMENTAL

DHES0815A

Intervention Type DRUG

DHES0815A will be administered via intravenous (IV) infusion on Day 1 of each 21-day cycle.

Dose Expansion Cohort: DHES0815A

Participants will be treated at or below the Maximum Tolerated Dose (MTD) of DHES0815A (based on the review of the totality of the data) to obtain additional safety, tolerability, PK, and anti-tumor activity data.

Group Type EXPERIMENTAL

DHES0815A

Intervention Type DRUG

DHES0815A will be administered via intravenous (IV) infusion on Day 1 of each 21-day cycle.

Interventions

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DHES0815A

DHES0815A will be administered via intravenous (IV) infusion on Day 1 of each 21-day cycle.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Measurable disease by RECIST v1.1 with at least one measurable target lesion
* Locally advanced or metastatic HER2-positive breast cancer that has relapsed or is refractory to established therapies
* Adequate hematologic and end-organ function
* For dose-expansion cohort only: no more than two prior systemic chemotherapy-containing regimens in the advanced/metastatic setting (excluding trastuzumab emtansine, which is considered a targeted cytotoxic agent)

Exclusion Criteria

* Treatment with chemotherapy, hormonal therapy (except hormone replacement therapy, oral contraceptives), immunotherapy, biologic therapy, radiation therapy (except palliative radiation to bony metastases), or herbal therapy as cancer therapy within 4 weeks prior to initiation of DHES0815A
* History of exposure to the protocol specified doses of anthracyclines
* Pregnancy, lactation, or breastfeeding
* Major surgical procedure within 4 weeks prior to Day 1
* Evidence of a significant uncontrolled concomitant disease of the nervous system, pulmonary, autoimmune, renal, hepatic, endocrine, or gastrointestinal disorders; or a serious non-healing wound or fracture
* Known active bacterial, viral, fungal, mycobacterial, or other infection
* Clinically significant history of liver disease, including active viral or other hepatitis, current alcohol abuse, or cirrhosis
* Untreated or active central nervous system (CNS) metastases
* Cardiopulmonary dysfunction, including inadequate left ventricular ejection function at baseline, less than 50% by either echocardiogram (ECHO) or multiple-gated acquisition scan (MUGA)
* QT interval corrected through use of Fridericia's formula (QTcF) \> 470 milliseconds (ms)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No