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Cancer drug enhertu gets a shot in the arm: new Under-the-Skin version tested

NCT ID NCT07015697

Disease control Sponsor: Daiichi Sankyo Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 10, 2026 · Updated 2 times

Summary

This early-phase trial is testing a new way to give the cancer drug T-DXd (Enhertu) — as a shot under the skin instead of an IV drip. The study will enroll 76 adults with metastatic solid tumors to find the safest dose and see how well the body handles it. Researchers will also check if the drug shrinks tumors and how convenient the shot is for patients.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Trastuzumab deruxtecan (T-DXd, Enhertu) plus hyaluronidase, given as a shot under the skin
What this could lead to
If it works, this could offer a more convenient way to give T-DXd, potentially reducing treatment time and improving comfort for patients with certain metastatic cancers.
What could go wrong
This is an early Phase 1 trial with only 76 participants, so safety and effectiveness are not yet proven. The subcutaneous version may not work as well as the IV form, and side effects could be different or serious.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 76 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2025

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: 1. Adults ≥18 years or the minimum legal adult age (whichever is greater). 2. 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: * 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. b) Part 2 only: At least 1 RECIST 1.1 measurable lesion on CT or MRI. 3. Radiologic or objective evidence of disease progression on or after the last systemic therapy prior to starting trial intervention. Key Exclusion Criteria: 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.

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Conditions

The condition(s) this trial relates to.

breast carcinoma gastroesophageal junction adenocarcinoma HER2 positive breast carcinoma metastatic malignant neoplasm non-small cell lung carcinoma Recurrence

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Recurrent or metastatic solid tumors

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    31 sites in 7 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Research Site

    RECRUITING

    Newport Beach, California, 92663, United States

  • Research Site

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Research Site

    RECRUITING

    Las Vegas, Nevada, 89169, United States

  • Research Site

    RECRUITING

    Charlotte, North Carolina, 28204, United States

  • Research Site

    RECRUITING

    Maumee, Ohio, 43537, United States

  • Research Site

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Research Site

    NOT_YET_RECRUITING

    Asa Sul, 70200-730, Brazil

  • Research Site

    NOT_YET_RECRUITING

    Goiás, 74605-070, Brazil

  • Research Site

    NOT_YET_RECRUITING

    Porto Alegre, 90020-090, Brazil

  • Research Site

    NOT_YET_RECRUITING

    Santo André, 09060-650, Brazil

  • Research Site

    NOT_YET_RECRUITING

    São Paulo, 01317-000, Brazil

  • Research Site

    RECRUITING

    Rennes, France

  • Research Site

    RECRUITING

    Chiba, Japan

  • Research Site

    RECRUITING

    Kanagawa, 241-8515, Japan

  • Research Site

    RECRUITING

    Tokyo, 104-0045, Japan

  • Research Site

    RECRUITING

    Tokyo, 135-8550, Japan

  • Research Site

    RECRUITING

    Tokyo, 142-8666, Japan

  • Research Site

    RECRUITING

    Seongnam-si, South Korea

  • Research Site

    RECRUITING

    Seoul, 03722, South Korea

  • Research Site

    RECRUITING

    Seoul, 06351, South Korea

  • Research Site

    RECRUITING

    Seoul, 3080, South Korea

  • Research Site

    RECRUITING

    Seoul, South Korea

  • Research Site

    RECRUITING

    Barcelona, Spain

  • Research Site

    RECRUITING

    Madrid, Spain

  • Research Site

    RECRUITING

    Seville, Spain

  • Research Site

    RECRUITING

    Taichung, Taiwan

  • Research Site

    RECRUITING

    Tainan, Taiwan

  • Research Site

    RECRUITING

    Taipei, 10002, Taiwan

  • Research Site

    RECRUITING

    Taipei, Taiwan

  • Research Site

    RECRUITING

    Taoyuan City, Taiwan

  • Research Site Saint

    RECRUITING

    Herblain, France

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