Actively Recruiting
A Study 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
180 weeks
Total Duration
On this page
Sponsors
D
Daiichi Sankyo
Lead Sponsor
A
AstraZeneca
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a dose escalation, and dose expansion study of T-DXd plus hyaluronidase administered subcutaneously, to assess the safety, tolerability, PK and efficacy of SC T-DXd plus hyaluronidase in participants with metastatic solid tumors.
CONDITIONS
Official Title
A Study of Subcutaneous Trastuzumab Deruxtecan in Participants With Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent before starting any trial-specific procedures.
- Adults aged 18 years or older.
- Documented HER2 test result if required for eligibility, using validated or approved tests per local regulations.
- For breast cancer participants: documented unresectable or metastatic breast cancer with specified HER2 and hormone receptor status and prior treatments as detailed.
- For NSCLC: unresectable or metastatic NSCLC with activating HER2 mutations and prior systemic therapy.
- For gastric cancer: locally advanced or metastatic HER2-positive adenocarcinoma with prior anti-HER2 therapy.
- Pan-tumor HER2-positive solid tumors with prior treatment or no satisfactory alternatives.
- Heavily pretreated metastatic solid tumors with prior systemic treatment and no satisfactory alternatives.
- Radiologic or objective evidence of disease progression after last systemic therapy.
- For Part 2: at least one measurable lesion by RECIST 1.1 on CT or MRI.
- For Part 2: availability of recent tumor tissue sample or newly obtained tissue if feasible.
- ECOG performance status of 0 to 1.
You will not qualify if you...
- Prior treatment with antibody-drug conjugates containing exatecan derivatives unless specific safety criteria are met.
- History of severe allergic reactions to the study drug components or other monoclonal antibodies.
- History of myocardial infarction within 6 months or symptomatic congestive heart failure (NYHA class II-IV).
- Elevated troponin levels without myocardial infarction must be evaluated by a cardiologist before enrollment.
- Corrected QT interval (QTcF) longer than 480 ms on screening ECG.
- History or current interstitial lung disease or pneumonitis that required steroids, or suspected cases not ruled out by imaging at screening.
AI-Screening
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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
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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