A Study of Subcutaneous Trastuzumab Deruxtecan in Participants With Metastatic Solid Tumors
NCT ID: NCT07015697
Last Updated: 2025-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
76 participants
INTERVENTIONAL
2025-07-17
2028-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Part 1 (Dose Escalation)
Participants will receive Trastuzumab Deruxtecan subcutaneously at escalating doses. The recommended dose for expansion (RDE) will be calculated using data collected from this population.
Trastuzumab Deruxtecan
Dose Escalation Part: Trastuzumab Deruxtecan will be administered at escalating doses to determine the RDE.
Expansion Part: Trastuzumab Deruxtecan will be administered at RDE.
Part 2 (Dose Expansion)
Participants will receive Trastuzumab Deruxtecan subcutaneously at the recommended dose for expansion (RDE)
Trastuzumab Deruxtecan
Dose Escalation Part: Trastuzumab Deruxtecan will be administered at escalating doses to determine the RDE.
Expansion Part: Trastuzumab Deruxtecan will be administered at RDE.
Interventions
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Trastuzumab Deruxtecan
Dose Escalation Part: Trastuzumab Deruxtecan will be administered at escalating doses to determine the RDE.
Expansion Part: Trastuzumab Deruxtecan will be administered at RDE.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Adults ≥18 years or the minimum legal adult age (whichever is greater).
3. Part 1 (Dose Escalation):
Note: all HR testing and HER2 testing shall be per ASCO/CAP guidelines, respectively, in the metastatic or locally advanced setting, as applicable.
a. ER+ or ER-, HER2-positive: adults with documented unresectable or metastatic HER2-positive BC as determined by following ASCO/CAP guideline for HER2 testing in BC, using a validated or approved test per applicable regulations, who have received a prior anti-HER2-based regimen either: in the metastatic setting, or in the neoadjuvant or adjuvant setting and have developed disease recurrence during or within 6 months of completing therapy. OR
ER-, HER2-low:
Adults with documented unresectable or metastatic ER-, HER2-low (IHC 1+ or IHC 2+/ISH-) BC, as determined by following ASCO/CAP guidelines for HER2 testing in BC 2023, using a validated or approved test per applicable regulations, who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy. OR
HR+, HER2-low:
Adults who are candidates for cytotoxic systemic treatment and have pathologically documented breast cancer that: is advanced or metastatic; has a documented HER2-low expression (IHC 1+ or IHC 2+/ISH-), as determined by following ASCO/CAP guidelines for HER2 testing in BC 2023, using a validated or approved test per applicable regulations, in the metastatic setting; was never previously diagnosed with HER2-positive (IHC 3+ or ISH+) disease as per ASCO/CAP guidelines. is documented as HR+ (either ER and/or PgR positive \[ER or PgR ≥1%\]) per ASCO/CAP guidelines in the metastatic setting. If a patient has had multiple ER/PgR results after metastatic disease, the most recent test result will be used to confirm eligibility. has been treated with no more than 2 previous lines of chemotherapy in the recurrent or metastatic setting. had disease progression on at least one previous line of ET with or without a targeted therapy (such as CDK4/6, mTOR or PI3-K inhibitors) administered for the treatment of metastatic disease. Of note with regards to participants who received only one previous line of
ET:
* If the one line was given while in the metastatic setting, it should have been administered with CDK4/6i to be considered a line of therapy
* If the one line was given while in the adjuvant setting, if disease recurrence occurred while on the first 24 months of adjuvant ET, that will be considered a line of therapy
* Changes in dosing schedules, or discontinuations/restarting of the same drugs or the addition of a targeted therapy to an ET without progression (eg, adding a CDK4/6 inhibitor to a current aromatase inhibitor regimen) will not be considered separate lines of therapy.
Part 2 (Dose Expansion):
Note: all HR testing and HER2 testing shall be per ASCO/CAP guidelines, respectively, in the metastatic or locally advanced setting, as applicable.
1. Adults who are candidates for cytotoxic systemic treatment and have pathologically documented breast cancer that: is advanced or metastatic; has a documented HER2-low expression (IHC 1+ or IHC 2+/ISH-), as determined by following ASCO/CAP guidelines for HER2 testing in BC 2023, using a validated or approved test per applicable regulations, in the metastatic setting; was never previously diagnosed with HER2-positive (IHC 3+ or ISH+) disease as per ASCO/CAP guidelines. is documented as HR+ (ER and/or PgR positive \[ER or PgR ≥1%\]) per ASCO/CAP guidelines in the metastatic setting. If a patient has had multiple ER/PgR results after metastatic disease, the most recent test result will be used to confirm eligibility. has been treated with no more than 2 previous lines of chemotherapy in the recurrent or metastatic setting. had disease progression on at least one previous line of ET with or without a targeted therapy (such as CDK4/6, mTOR or PI3-K inhibitors) administered for the treatment of metastatic disease. Of note with regards to participants who received only one previous line of
ET:
* If the one line was given while in the metastatic setting, it should have been administered with CDK4/6i to be considered a line of therapy
* If the one line was given while in the adjuvant setting, if disease recurrence occurred while on the first 24 months of adjuvant ET, that will be considered a line of therapy
* Changes in dosing schedules, or discontinuations/restarting of the same drugs or the addition of a targeted therapy to an ET without progression (eg, adding a CDK4/6 inhibitor to a current aromatase inhibitor regimen) will not be considered separate lines of therapy.
2. At least one RECIST 1.1 measurable lesion on CT or MRI
Exclusion Criteria
2. Has a history of severe hypersensitivity reactions to either the drug substances or inactive ingredients in the drug products.
3. Has a history of severe hypersensitivity reactions to other monoclonal antibodies.
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.
18 Years
ALL
No
Sponsors
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Daiichi Sankyo
INDUSTRY
AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
Newport Beach, California, United States
Research Site
Atlanta, Georgia, United States
Research Site
Charlotte, North Carolina, United States
Research Site
Maumee, Ohio, United States
Research Site
Nashville, Tennessee, United States
Research Site
Kanagawa, , Japan
Research Site
Tokyo, , Japan
Research Site
Tokyo, , Japan
Research Site
Tokyo, , Japan
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Taipei, , Taiwan
Countries
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Central Contacts
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Other Identifiers
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DS8201-801
Identifier Type: -
Identifier Source: org_study_id