Actively Recruiting
A Phase 1, Multicenter Trial of Subcutaneous Trastuzumab Deruxtecan in Participants With Metastatic Solid Tumors
Led by Daiichi Sankyo · Updated on 2026-03-20
76
Participants Needed
26
Research Sites
N/A
Total Duration
On this page
Sponsors
D
Daiichi Sankyo
Lead Sponsor
A
AstraZeneca
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, pharmacokinetics, and effectiveness of subcutaneous Trastuzumab Deruxtecan combined with hyaluronidase in adults with metastatic solid tumors. This Phase 1 study focuses on determining the appropriate dose and expanding the treatment to assess its impact on participants with various types of advanced cancer, including breast cancer, non-small cell lung cancer, and gastric cancer. The study is led by Daiichi Sankyo and seeks to gather important data on how this treatment works in the body and its side effects. Participants will receive Trastuzumab Deruxtecan injected under the skin at increasing doses during the dose escalation phase to find the recommended dose for expansion. Following this, participants will receive the treatment at the recommended dose in the expansion phase. The study involves two parts: first, testing different doses for safety and then treating participants at the chosen dose to further evaluate treatment effects. The treatment schedule includes monitoring for side effects and response to therapy over several months. During the study, participants will undergo regular assessments including monitoring for adverse events, blood tests to study drug levels, and imaging scans to track tumor response. Researchers will collect data on any side effects experienced, immune responses to the drug, and overall disease progression. Safety will be followed up for up to 21 days after the last dose, with some measures tracked for up to 12 months. Participants may expect visits for physical exams, laboratory tests, and tumor assessments throughout the study period which may last several months.
CONDITIONS
Brief Title
A Study of Subcutaneous Trastuzumab Deruxtecan in Participants With Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Sign and date the informed consent form before starting any trial procedures.
- Adults aged 18 years or older.
- Documented HER2 test results if required for eligibility, according to local regulations and guidelines.
- Pathologically confirmed unresectable or metastatic breast cancer, NSCLC with HER2 mutations, gastric cancer with HER2 positivity, or other metastatic solid tumors as defined.
- Prior anti-HER2 treatment for HER2-positive breast or gastric cancer as specified.
- Evidence of disease progression on or after last systemic therapy.
- For expansion phase participants: at least one measurable lesion on CT or MRI.
- Availability of recent tumor tissue sample or willingness to provide a new sample if feasible.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
You will not qualify if you...
- Prior treatment with antibody-drug conjugates containing an exatecan derivative unless specific conditions are met.
- History of severe allergic reactions to the study drug substances or other monoclonal antibodies.
- History of myocardial infarction within 6 months before enrollment or symptomatic congestive heart failure (NYHA class II-IV).
- Elevated troponin levels without symptoms requiring cardiology consultation.
- Prolonged corrected QT interval (QTcF > 480 ms) on screening ECG.
- History or current evidence of interstitial lung disease or pneumonitis that required steroids or cannot be ruled out by imaging at screening.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 9 months
Participants receive subcutaneous Trastuzumab Deruxtecan at escalating doses or at the recommended dose for expansion (RDE) depending on the trial phase.
Regular visits during dosing period
Duration - Up to approximately 12 months
Participants are monitored for treatment emergent adverse events and response until approximately 12 months from enrollment.
Periodic visits for safety and response assessments
Trial Site Locations
Total: 26 locations
1
Research Site
Newport Beach, California, United States, 92663
Actively Recruiting
2
Research Site
Atlanta, Georgia, United States, 30322
Actively Recruiting
3
Research Site
Las Vegas, Nevada, United States, 89169
Actively Recruiting
4
Research Site
Charlotte, North Carolina, United States, 28204
Actively Recruiting
5
Research Site
Maumee, Ohio, United States, 43537
Actively Recruiting
6
Research Site
Nashville, Tennessee, United States, 37203
Actively Recruiting
7
Research Site Saint
Herblain, France
Actively Recruiting
8
Research Site
Rennes, France
Actively Recruiting
9
Research Site
Chiba, Japan
Actively Recruiting
10
Research Site
Kanagawa, Japan, 241-8515
Actively Recruiting
11
Research Site
Tokyo, Japan, 104-0045
Actively Recruiting
12
Research Site
Tokyo, Japan, 135-8550
Actively Recruiting
13
Research Site
Tokyo, Japan, 142-8666
Actively Recruiting
14
Research Site
Seongnam-si, South Korea
Actively Recruiting
15
Research Site
Seoul, South Korea, 03722
Actively Recruiting
16
Research Site
Seoul, South Korea, 06351
Actively Recruiting
17
Research Site
Seoul, South Korea, 3080
Actively Recruiting
18
Research Site
Seoul, South Korea
Actively Recruiting
19
Research Site
Barcelona, Spain
Actively Recruiting
20
Research Site
Madrid, Spain
Actively Recruiting
21
Research Site
Seville, Spain
Actively Recruiting
22
Research Site
Taichung, Taiwan
Actively Recruiting
23
Research Site
Tainan, Taiwan
Actively Recruiting
24
Research Site
Taipei, Taiwan, 10002
Actively Recruiting
25
Research Site
Taipei, Taiwan
Actively Recruiting
26
Research Site
Taoyuan City, Taiwan
Actively Recruiting
Research Team
C
Contact for Trial Information
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here