Clinical Trials List
Protocol NumberDS8201-801
NCT Number(ClinicalTrials.gov Identfier)NCT07015697
Not yet recruiting
2025-06-30 - 2028-12-31
Phase I
Recruiting5
ICD-10C50.011
Malignant neoplasm of nipple and areola, right female breast
ICD-10C50.012
Malignant neoplasm of nipple and areola, left female breast
ICD-10C50.019
Malignant neoplasm of nipple and areola, unspecified female breast
ICD-10Z51.12
Encounter for antineoplastic immunotherapy
ICD-9174.0
Malignant neoplasm of female breast, nipple and areola
A Phase 1, Multicenter Trial of Subcutaneous Trastuzumab Deruxtecan in Participants With Metastatic Solid Tumors
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Trial Applicant
Daiichi Sankyo Taiwan Ltd.
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Sponsor
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- 陳怡君 Division of Hematology & Oncology
- 黃柏翔 Division of Hematology & Oncology
- 魏以宣 Division of Ophthalmology
- 楊明翰 Division of Hematology & Oncology
- 林柏翰 Division of General Internal Medicine
- MING-YANG WANG Division of Hematology & Oncology
- Wei-Wu Chen Division of Hematology & Oncology
- WEI-LI MA Division of Hematology & Oncology
- 張端瑩 Division of Hematology & Oncology
- 林季宏 Division of Hematology & Oncology
- 羅喬 Division of General Surgery
- 李佳真 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Wen-Chi Shen Division of Hematology & Oncology
- Chi-Chang Yu Division of General Surgery
- Wen-Ling Kuo Division of General Surgery
- Yung-Chang Lin Division of Hematology & Oncology
- Chan-Keng Yang Division of Hematology & Oncology
- 沈士哲 Division of General Surgery
- Mengting Peng Division of Hematology & Oncology
- 周旭桓 Division of General Surgery
- Chun-Hsiu Liu Division of Ophthalmology
- 阮昱翔 Division of Radiology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Chen-Teng Wu Division of General Surgery
- Liang-Chih Liu Division of General Surgery
- 蘇孟夏 Division of General Surgery
- Yao-Chung Wu Division of General Surgery
- 黃至豪 Division of General Surgery
- Chih-Jung Chen Division of General Surgery
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Wei-Pang Chung
Co-Principal Investigator
- Jui-Hung Tsai Division of Hematology & Oncology
- 楊舜如 Division of Hematology & Oncology
- 黃怡菁 Division of Hematology & Oncology
- Chun-Hui Lee Division of Hematology & Oncology
- Shang-Hung Chen
- Kuo-Ting Lee Division of General Surgery
- 魏慈慧
- Zhu-Jun Loh Division of General Surgery
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Recurrent or Metastatic Solid Tumors
Objectives
This is a dose escalation and dose expansion study of subcutaneous trastuzumab deruxtecan (T-DXd) plus hyaluronidase, designed to evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of subcutaneous T-DXd plus hyaluronidase in subjects with metastatic solid tumors.
Test Drug
Frozen crystal powder and liquid for injection
Active Ingredient
DS-8201a plus hyaluronidase
Dosage Form
24B
Dosage
subcutaneous T-DXd 300 mg; ALT-BB4 1500 IU/mL
Endpoints
Key Inclusion Criteria:
Sign and date the ICF, prior to the start of any trial- specific qualification procedures.
Adults ≥18 years or the minimum legal adult age (whichever is greater).
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.
Sign and date the ICF, prior to the start of any trial- specific qualification procedures.
Adults ≥18 years or the minimum legal adult age (whichever is greater).
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.
Inclution Criteria
Key Inclusion Criteria:
Sign and date the ICF, prior to the start of any trial- specific qualification procedures.
Adults ≥18 years or the minimum legal adult age (whichever is greater).
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.
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.
At least one RECIST 1.1 measurable lesion on CT or MRI
Sign and date the ICF, prior to the start of any trial- specific qualification procedures.
Adults ≥18 years or the minimum legal adult age (whichever is greater).
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.
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.
At least one RECIST 1.1 measurable lesion on CT or MRI
Exclusion Criteria
Key Exclusion Criteria:
Prior treatment with ADC that consists of an exatecan derivative that is a topoisomerase I inhibitor.
Has a history of severe hypersensitivity reactions to either the drug substances or inactive ingredients in the drug products.
Has a history of severe hypersensitivity reactions to other monoclonal antibodies.
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.
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.
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.
Prior treatment with ADC that consists of an exatecan derivative that is a topoisomerase I inhibitor.
Has a history of severe hypersensitivity reactions to either the drug substances or inactive ingredients in the drug products.
Has a history of severe hypersensitivity reactions to other monoclonal antibodies.
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.
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.
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.
The Estimated Number of Participants
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Taiwan
15 participants
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Global
76 participants
