Recurrent or Metastatic Solid TumorsPhase 1NCT07015697
A Study of Subcutaneous Trastuzumab Deruxtecan in Participants With Metastatic Solid Tumors
A Phase 1 study testing Trastuzumab Deruxtecan in people with Recurrent or Metastatic Solid Tumors, run by Daiichi Sankyo at 31 sites in 7 countries.
Trial summary
This dose escalation and dose expansion study was designed to assess the safety, tolerability, PK and efficacy of subcutaneous T-DXd in participants with metastatic solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent or Metastatic Solid Tumors
- What is being tested?
- Trastuzumab Deruxtecan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 31 sitesin 7 countries
- Study dates
- 17 Jul 2025to 31 Dec 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults ≥18 years or the minimum legal adult age (whichever is greater).
- a) Disease State: If HER2 status is required for eligibility (for all populations), a documented HER2 test result must be available.
- Breast Cancer: adults with pathologically documented unresectable or metastatic breast cancer HER2-positive BC: have received a prior anti-HER2-based regimen. For HER2-positive BC participants in Part 2 only, prior anti-HER2 based therapy should have been received in either:
- the metastatic setting, or
- the neoadjuvant or adjuvant setting and have developed disease recurrence during or within 6 months of completing therapy. HR-, HER2-low BC: have received a prior systemic cytotoxic therapy in the metastatic setting; or developed disease recurrence during or within 6 months of completing (neo)adjuvant chemotherapy. HR+, HER2-low/ultralow BC: have received previous ET AND an additional line of ET must not be the next line of treatment considered in the participant's best interest.
- For participants in Part 2 with HR+ HER-2low/ultralow BC, the following criteria also apply:
Show all 11Show fewer
- had disease progression while receiving 1 previous line of ET with a CDK4/6i and is not expected to benefit from immediate use of a second line of ET, OR
- had disease progression on at least 2 previous lines of ET with or without a target therapy such as CDK4/6, mTOR or PI3-K inhibitors) administered for the treatment of metastatic disease
- participants may not have received more than 2 prior lines of cytotoxic therapy in the recurrent or metastatic setting. NSCLC, HER2 mut: adults with unresectable or metastatic NSCLC whose tumors have activating HER2 (ERBB2) mutations, and who have received a prior systemic therapy.
- Part 2 only: At least 1 RECIST 1.1 measurable lesion on CT or MRI.
- Radiologic or objective evidence of disease progression on or after the last systemic therapy prior to starting trial intervention.
Who cannot join
- 1. Prior treatment with ADC that consists of an exatecan derivative that is a topoisomerase I inhibitor; 4. Medical history of MI within 6 months before enrollment or symptomatic CHF (New York Heart Association class II to IV). Participants with troponin levels above ULN at screening (as defined by the manufacturer), and without any MI-related symptoms should have a cardiologic consultation during the Screening Period to rule out MI.
- 5. Has a corrected QT interval (QTcF) prolongation to > 480 ms (regardless of participant's sex) based on average of the screening triplicate 12-lead ECG. 6. Has a history of (non-infectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
Trial locations and contacts
31 sites in 7 countries. Contact the study team or a site near you to ask about taking part.
31 sites in 7 countries
United States6 sites, 6 recruiting
- Recruiting
Research Site
Atlanta, Georgia, 30322
- Recruiting
Research Site
Charlotte, North Carolina, 28204
- Recruiting
Research Site
Las Vegas, Nevada, 89169
- Recruiting
Research Site
Maumee, Ohio, 43537
- Recruiting
Research Site
Nashville, Tennessee, 37203
- Recruiting
Research Site
Newport Beach, California, 92663
Brazil5 sites, 5 recruiting
- Not yet recruiting
Research Site
Asa Sul, 70200-730
- Not yet recruiting
Research Site
Goiás, 74605-070
- Not yet recruiting
Research Site
Porto Alegre, 90020-090
- Not yet recruiting
Research Site
Santo André, 09060-650
- Not yet recruiting
Research Site
São Paulo, 01317-000
Japan5 sites, 5 recruiting
- Recruiting
Research Site
Chiba
- Recruiting
Research Site
Kanagawa, 241-8515
- Recruiting
Research Site
Tokyo, 104-0045
- Recruiting
Research Site
Tokyo, 135-8550
- Recruiting
Research Site
Tokyo, 142-8666
South Korea5 sites, 5 recruiting
- Recruiting
Research Site
Seongnam-si
- Recruiting
Research Site
Seoul, 03722
- Recruiting
Research Site
Seoul, 06351
- Recruiting
Research Site
Seoul, 3080
- Recruiting
Research Site
Seoul
Taiwan5 sites, 5 recruiting
- Recruiting
Research Site
Taichung
- Recruiting
Research Site
Tainan
- Recruiting
Research Site
Taipei, 10002
- Recruiting
Research Site
Taipei
- Recruiting
Research Site
Taoyuan City
Spain3 sites, 3 recruiting
- Recruiting
Research Site
Barcelona
- Recruiting
Research Site
Madrid
- Recruiting
Research Site
Seville
France2 sites, 2 recruiting
- Recruiting
Research Site Saint
Herblain
- Recruiting
Research Site
Rennes
About this study
Official title: A Phase 1, Multicenter Trial of Subcutaneous Trastuzumab Deruxtecan in Participants With Metastatic Solid Tumors
This dose escalation and dose expansion study was designed to assess the safety, tolerability, PK and efficacy of subcutaneous T-DXd in participants with metastatic solid tumors.
- Conditions
- Recurrent or Metastatic Solid Tumors
- Being tested
- Trastuzumab Deruxtecan
- Keywords
- T-DXd, solid tumor, subcutaneous
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trastuzumab DeruxtecanDrug
Also called T-DXd, ENHERTU®
Dose Escalation Part: Trastuzumab Deruxtecan will be administered at escalating doses to determine the RDE.
Expansion Part: Trastuzumab Deruxtecan will be administered at RDE.
| Study group | Role | What they receive |
|---|---|---|
| Part 1 (Dose Escalation) | Experimental | Participants will receive Trastuzumab Deruxtecan subcutaneously at escalating doses. The recommended dose for expansion (RDE) will be calculated using data collected from this population. Receives: Drug: Trastuzumab Deruxtecan |
| Part 2 (Dose Expansion) | Experimental | Participants will receive Trastuzumab Deruxtecan subcutaneously at the recommended dose for expansion (RDE) Receives: Drug: Trastuzumab Deruxtecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Experiencing a Treatment Emergent Adverse Event (TEAE)
TEAEs are defined as those Adverse Events (AEs) with start or worsening date during the on-treatment period (from the first dose date of trial intervention to 21 days after the last dose date of trial intervention).
Measured: From the start of trial intervention to 21 days after the last dose, up to approximately 9 months
Area Under Curve (AUC)
Measured: From the start of trial intervention to last dose, up to approximately 9 months
Number of Participants with Dose limiting toxicities (DLT) During the Dose-Escalation Phase
Measured: From the start of trial intervention to 21 days after the last dose, up to approximately 9 months
Secondary outcomes (3)
Percentage of Participants with Anti-Drug Antibody (ADAs)
Measured: From baseline to post-baseline, up to approximately 12 months
Overall Response Rate (ORR)
ORR is defined as the proportion of participants who achieved a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), as assessed by investigator per RECIST v1.1
Measured: From the enrollment/randomization date until documented disease progression, up to 12 months
Disease Control Rate (DCR)
DCR is defined as the proportion of participants with a BOR of confirmed CR, confirmed PR, or stable disease (SD) per RECIST v1.1.
Measured: From the enrollment/randomization date until documented disease progression, up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2025
- Study start17 Jul 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent or Metastatic Solid TumorsStudies of the same condition, open and under way.
- More trials run by Daiichi SankyoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07015697
- Sponsor's protocol ID
- DS8201-801
- Status last verified
- Jul 2026
- First submitted
- 3 Jun 2025
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) on completed studies and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Multicenter Trial of Subcutaneous Trastuzumab Deruxtecan in Participants With Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT07015697
- Acronym / sponsor ID
- DS8201-801
- Conditions
- Recurrent or Metastatic Solid Tumors
- Keywords
- T-DXd, solid tumor, subcutaneous
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Daiichi SankyoIndustry (pharma, biotech, devices)
- Collaborators
- AstraZeneca
- Study start
- 17 Jul 2025 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 11 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This dose escalation and dose expansion study was designed to assess the safety, tolerability, PK and efficacy of subcutaneous T-DXd in participants with metastatic solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1 (Dose Escalation) | Experimental | Drug: Trastuzumab DeruxtecanParticipants will receive Trastuzumab Deruxtecan subcutaneously at escalating doses. The recommended dose for expansion (RDE) will be calculated using data collected from this population. |
| Part 2 (Dose Expansion) | Experimental | Drug: Trastuzumab DeruxtecanParticipants will receive Trastuzumab Deruxtecan subcutaneously at the recommended dose for expansion (RDE) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Adults ≥18 years or the minimum legal adult age (whichever is greater).
- a) Disease State: If HER2 status is required for eligibility (for all populations), a documented HER2 test result must be available.
- Breast Cancer: adults with pathologically documented unresectable or metastatic breast cancer HER2-positive BC: have received a prior anti-HER2-based regimen. For HER2-positive BC participants in Part 2 only, prior anti-HER2 based therapy should have been received in either:
- Radiologic or objective evidence of disease progression on or after the last systemic therapy prior to starting trial intervention.
Key exclusion criteria (2 listed)
- 1. Prior treatment with ADC that consists of an exatecan derivative that is a topoisomerase I inhibitor; 4. Medical history of MI within 6 months before enrollment or symptomatic CHF (New York Heart Association class II to IV). Participants with troponin levels above ULN at screening (as defined by the manufacturer), and without any MI-related symptoms should have a cardiologic consultation during the Screening Period to rule out MI.
- 5. Has a corrected QT interval (QTcF) prolongation to > 480 ms (regardless of participant's sex) based on average of the screening triplicate 12-lead ECG. 6. Has a history of (non-infectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trastuzumab DeruxtecanAlso: T-DXd, ENHERTU®Dose Escalation Part: Trastuzumab Deruxtecan will be administered at escalating doses to determine the RDE. Expansion Part: Trastuzumab Deruxtecan will be administered at RDE. | Drug | Part 1 (Dose Escalation), Part 2 (Dose Expansion) |
Primary outcome
Number of Participants Experiencing a Treatment Emergent Adverse Event (TEAE)
Time frame: From the start of trial intervention to 21 days after the last dose, up to approximately 9 months
TEAEs are defined as those Adverse Events (AEs) with start or worsening date during the on-treatment period (from the first dose date of trial intervention to 21 days after the last dose date of trial intervention).
Area Under Curve (AUC)
Time frame: From the start of trial intervention to last dose, up to approximately 9 months
Number of Participants with Dose limiting toxicities (DLT) During the Dose-Escalation Phase
Time frame: From the start of trial intervention to 21 days after the last dose, up to approximately 9 months
3 secondary outcomes
Percentage of Participants with Anti-Drug Antibody (ADAs)
Time frame: From baseline to post-baseline, up to approximately 12 months
Overall Response Rate (ORR)
Time frame: From the enrollment/randomization date until documented disease progression, up to 12 months
Disease Control Rate (DCR)
Time frame: From the enrollment/randomization date until documented disease progression, up to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) on completed studies and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
31 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Trastuzumab Deruxtecan in people with Recurrent or Metastatic Solid Tumors, run by Daiichi Sankyo at 31 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United States, Brazil, Japan, South Korea, Taiwan and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Contact for Trial Information (908-992-6400, CTRinfo_us@daiichisankyo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Experiencing a Treatment Emergent Adverse Event (TEAE) (time frame: From the start of trial intervention to 21 days after the last dose, up to approximately 9 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.