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Study of Subcutaneous Trastuzumab Deruxtecan for Metastatic Solid Tumors

This study is testing a drug called Trastuzumab Deruxtecan, given as a shot under the skin, for people with solid tumors that have spread (metastatic) or come back (recurrent). The main goals are to see how safe the drug is, what side effects it causes, and how much of it stays in the body. Researchers will also look at how well it works. You might be able to join if you are an adult aged 18 or older with metastatic solid tumors. For some cancers like breast cancer, you would need to have a specific marker called HER2 and have already received anti-HER2 treatment. The study plans to enroll about 76 participants, but its current status is unclear.

Study design
This is an interventional study designed to find the right dose and then further test the drug. It aims to enroll about 76 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for side effects for up to 21 days after their last dose, for approximately 9 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07015697

A Study of Subcutaneous Trastuzumab Deruxtecan in Participants With Metastatic Solid Tumors

Recruiting
PHASE1Ages 18+InterventionalTreatment
Daiichi Sankyo
~76 participants
Updated 2026-07-09 on ClinicalTrials.gov
What's tested:Trastuzumab Deruxtecan

At a glance

Recruiting sites
26 of 31 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants Experiencing a Treatment Emergent Adverse Event (TEAE)
Measured over From the start of trial intervention to 21 days after the last dose, up to approximately 9 months
+2 more outcomes measured

Conditions

Recurrent or Metastatic Solid Tumors

Explore related trials

Breast CarcinomaLung Non-Small Cell CarcinomaSolid Neoplasm

Where it's being run

31 sites across 12 states
Brazil5
Japan5
South Korea5
Taiwan5
Spain3
France2
California1
Georgia1

Who to contact

Contact for Trial Information
[email protected]
908-992-6400
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.

What this trial measures

  • Number of Participants Experiencing a Treatment Emergent Adverse Event (TEAE)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)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 PhaseFrom the start of trial intervention to 21 days after the last dose, up to approximately 9 months