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

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ClinicalTrials.gov Identifier: NCT03451162
Recruitment Status : Recruiting
First Posted : March 1, 2018
Last Update Posted : October 23, 2018
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: DHES0815A Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 55 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : April 17, 2018
Estimated Primary Completion Date : January 1, 2022
Estimated Study Completion Date : January 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: 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.
Drug: DHES0815A
DHES0815A will be administered via intravenous (IV) infusion on Day 1 of each 21-day cycle.

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




Primary Outcome Measures :
  1. Percentage of Participants with Adverse Events (AEs) and Serious AEs [ Time Frame: From Day 1 to end of study (up to approximately 45 months) ]
  2. Percentage of Participants with DLT [ Time Frame: From Day 1 up to Day 21 ]
  3. MTD of DHES0815A [ Time Frame: From Day 1 up to Day 21 ]
  4. Recommended Phase 2 Dose (RP2D) of DHES0815A [ Time Frame: From Day 1 up to Day 21 ]

Secondary Outcome Measures :
  1. Concentration of DHES0815A [ Time Frame: Cycle 1 Day 1 up to 42 days after last dose (up to approximately 45 months) (Cycle length = 21 days) ]
  2. Area Under the Concentration-Time Curve (AUC) of DHES0815A [ Time Frame: Cycle 1 Day 1 up to 42 days after last dose (up to approximately 45 months) (Cycle length = 21 days) ]
  3. Maximum Observed blood Concentration (Cmax) of DHES0815A [ Time Frame: Cycle 1 Day 1 up to 42 days after last dose (up to approximately 45 months) (Cycle length = 21 days) ]
  4. Minimum Observed blood Concentration (Cmin) of DHES0815A [ Time Frame: Cycle 1 Day 1 up to 42 days after last dose (up to approximately 45 months) (Cycle length = 21 days) ]
  5. Clearance of DHES0815A [ Time Frame: Cycle 1 Day 1 up to 42 days after last dose (up to approximately 45 months) (Cycle length = 21 days) ]
  6. Volume of Distribution at Steady State (Vss) of DHES0815A [ Time Frame: Cycle 1 Day 1 up to 42 days after last dose (up to approximately 45 months) (Cycle length = 21 days) ]
  7. Percentage of Participants with Objective Response Assessed According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) [ Time Frame: From start of treatment until confirmation of complete response (CR) or partial response (PR) (up to approximately 45 months) ]
  8. Duration of Response (DoR) Assessed According to RECIST v1.1 [ Time Frame: From the initial CR or PR to the time of disease progression (PD) or death, whichever occurs first (up to approximately 45 months) ]
  9. Percentage of Participants with Anti-Drug Antibody (ADA) to DHES0815A [ Time Frame: Pre-dose (0 hours) on Day 1 up to 42 days after last infusion (up to approximately 45 months) ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key 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)

Key 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 metastases
  • Cardiopulmonary dysfunction, including inadequate left ventricular ejection function at baseline, less than 50% by either echocardiogram or multiple-gated acquisition scan
  • QT interval corrected through use of Fridericia's formula (QTcF) > 470 milliseconds

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03451162


Contacts
Contact: Reference Study ID Number: GO39869 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global-roche-genentech-trials@gene.com

Locations
United States, Connecticut
Yale Cancer Center Recruiting
New Haven, Connecticut, United States, 06520
United States, Massachusetts
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
United States, New York
Columbia Univ Medical Center Recruiting
New York, New York, United States, 10032
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
United States, Tennessee
Sarah Cannon Research Institute Recruiting
Nashville, Tennessee, United States, 37203
Korea, Republic of
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 05505
Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT03451162     History of Changes
Other Study ID Numbers: GO39869
First Posted: March 1, 2018    Key Record Dates
Last Update Posted: October 23, 2018
Last Verified: October 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases