A study to find out whether a new medicine (DHES0815A) was safe and effective in patients with breast cancer

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

Cancer
Breast Cancer

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Basic Details

Gender

All

Age

≥ 18 Years

Healthy Volunteers

Sponsor Genentech, Inc.

Phase Phase 1

Study Identifier NCT03451162, GO39869

This clinical trial was done to study a new medicine called, “DHES0815A”, for the treatment of patients with a certain type of breast cancer called “HER2+ breast cancer”. This study was done to find the dose of DHES0815A that was safe for treating patients. Researchers were also interested in finding signs that showed that DHES0815A was useful to patients. Fourteen patients took part in this study at six study centers in two countries.

This page summarises information from public registry websites, such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc. To learn more about this study, see the For Medical Professional tab or visit one of those websites.

The information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

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In clinical research, volunteers, researchers, and medical professionals work together toward a shared goal: better treatment outcomes for patients. Clinical trials are vital to their process. They are carefully designed and follow approved protocols.

Basic Details

Sponsor Genentech, Inc.

Phase Phase 1

Trial Identifier NCT03451162, GO39869

Condition Breast Cancer

Official Title A Phase I, Open-Label Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Escalating Doses of DHES0815A in Patients With HER2-Positive Breast Cancer

Study Summary

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.

Eligibility Criteria

Gender

All

Age

≥ 18 Years

Healthy Volunteers

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)

The information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

Results Disclaimer

A study to find out whether a new medicine (DHES0815A) was safe and effective in patients with breast cancer

Basic Details

What you can do next

What is Clinical Research?

Basic Details

Study Summary

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

What is Clinical Research?

For the latest version of this information please go to www.forpatients.roche.com

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Find participating medical centers and current study status in each of them

A study to find out whether a new medicine (DHES0815A) was safe and effective in patients with breast cancer

Basic Details

What you can do next

Find participating medical centers and current study status in each of them

Explore related studies

What is Clinical Research?

For the latest version of this information please go to www.forpatients.roche.com