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

ConditionRecurrent or Metastatic Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorDaiichi Sankyo

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

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.

Disqualifiers

None

Trial design

Design model

Sequential

Treatments tested in this trial

  • Trastuzumab Deruxtecan

    Drug

    Dose Escalation Part: Trastuzumab Deruxtecan will be administered at escalating doses to determine the RDE. Expansion Part: Trastuzumab Deruxtecan will be administered at RDE.

Treatment groups

76 Participants
are divided into 2 treatment groups
Group A: Part 1 (Dose Escalation)Experimental treatment 1 intervention
Group B: Part 2 (Dose Expansion)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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
2

Area Under Curve (AUC)

Time frame
From the start of trial intervention to last dose, up to approximately 9 months
3

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

Secondary outcomes

1

Percentage of Participants with Anti-Drug Antibody (ADAs)

Time frame
From baseline to post-baseline, up to approximately 12 months
2

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
3

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Daiichi Sankyo

Lead sponsor

AstraZeneca

Collaborator

Source ClinicalTrials.gov
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