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New treatment option for Recurrent or Metastatic Solid Tumors
Official title A Study of Subcutaneous Trastuzumab Deruxtecan in Participants With Metastatic Solid Tumors
ClinicalTrials.gov ID: NCT07015697
What this study is testing
What is Trastuzumab Deruxtecan?
Trastuzumab Deruxtecan is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for recurrent or metastatic solid tumors.
Also referred to as T-DXd, ENHERTU®.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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...
- For participants in Part 2 with HR+ HER-2low/ultralow BC, the following criteria also apply:
You likely can't join if
- 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...
- 5\. Has a corrected QT interval (QTcF) prolongation to \> 480 ms (regardless of participant's sex) based on average of the screening triplicate...
See the full eligibility criteria
- 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...
- 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...
- 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...
- Radiologic or objective evidence of disease progression on or after the last systemic therapy prior to starting trial intervention. Key
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Newport Beach, California, United States
- Atlanta, Georgia, United States
- Las Vegas, Nevada, United States
- Charlotte, North Carolina, United States
- Maumee, Ohio, United States
- Nashville, Tennessee, United States
- Asa Sul, Brazil
- Goiás, Brazil
- Porto Alegre, Brazil
- Santo André, Brazil
- São Paulo, Brazil
- Herblain, France
- Rennes, France
- Chiba, Japan
- Kanagawa, Japan
- Tokyo, Japan
- Seongnam-si, South Korea
- Seoul, South Korea
- Barcelona, Spain
- Madrid, Spain
+ 5 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Newport Beach, California, United States; Atlanta, Georgia, United States; Las Vegas, Nevada, United States; Charlotte, North Carolina, United States; Maumee, Ohio, United States; Nashville, Tennessee, United States and 19 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.