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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
76
Dose Escalation Part: Trastuzumab Deruxtecan will be administered at escalating doses to determine the RDE. Expansion Part: Trastuzumab Deruxtecan will be administered at RDE.
Number of Participants Experiencing a Treatment Emergent Adverse Event (TEAE)
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).
Time frame: From the start of trial intervention to 21 days after the last dose, up to approximately 9 months
Area Under Curve (AUC)
Time frame: 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 Phase
Time frame: From the start of trial intervention to 21 days after the last dose, up to approximately 9 months
Percentage of Participants with Anti-Drug Antibody (ADAs)
Time frame: From baseline to post-baseline, up to approximately 12 months
Overall Response Rate (ORR)
ORR is defined as the proportion of participants who achieved a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), as assessed by investigator per RECIST v1.1
Time frame: From the enrollment/randomization date until documented disease progression, up to 12 months
Disease Control Rate (DCR)
DCR is defined as the proportion of participants with a BOR of confirmed CR, confirmed PR, or stable disease (SD) per RECIST v1.1.
Time frame: From the enrollment/randomization date until documented disease progression, up to 12 months
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Research Site
Newport Beach, California, United States
Research Site
Atlanta, Georgia, United States
RECRUITINGResearch Site
Las Vegas, Nevada, United States
RECRUITINGResearch Site
Charlotte, North Carolina, United States
RECRUITINGResearch Site
Maumee, Ohio, United States
RECRUITINGResearch Site
Nashville, Tennessee, United States
RECRUITINGResearch Site
Asa Sul, Brazil
NOT_YET_RECRUITINGResearch Site
Goiás, Brazil
NOT_YET_RECRUITINGResearch Site
Porto Alegre, Brazil
NOT_YET_RECRUITINGResearch Site
Santo André, Brazil
NOT_YET_RECRUITING...and 21 more locations