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A Phase 1b Multicentre, Open-label, Modular, Dose-finding and Dose-expansion Study to Explore the Safety, Tolerability, Pharmacokinetics and Anti-tumour Activity of Trastuzumab Deruxtecan (T-DXd) in Combination with Other Anti-cancer Agents in Patients with Metastatic HER2-low Breast Cancer (DESTINY-Breast08)

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-505690-33-00
Acronym
D967JC00002
Enrollment
12
Registered
2024-07-24
Start date
2022-03-11
Completion date
Unknown
Last updated
2026-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Breast Cancer

Brief summary

Part 1: AEs, SAEs, DLTs, laboratory findings, Part 2: AEs, SAEs, laboratory findings

Detailed description

Part 2: ORR defined as the proportion of patients who have a confirmed CR or PR, as determined by the investigator at local site per RECIST 1.1, Part 2: PFS defined as time from the date of first dose until the date of progression as determined by the investigator at local site per RECIST 1.1, or death due to any cause, Part 2: DoR defined as time from the date of first documented response (which is subsequently confirmed) until the date of documented progression or death in the absence of disease progression, Part 2: OS defined as time from the date of first dose until the date of death by any cause, Serum concentration of T-DXd, total anti-HER2 antibody and MAAA- 1181a, Serum concentration of durvalumab, Immunogenicity of T-DXd and durvalumab

Interventions

Sponsors

Astrazeneca AB
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Part 1: AEs, SAEs, DLTs, laboratory findings, Part 2: AEs, SAEs, laboratory findings

Secondary

MeasureTime frame
Part 2: ORR defined as the proportion of patients who have a confirmed CR or PR, as determined by the investigator at local site per RECIST 1.1, Part 2: PFS defined as time from the date of first dose until the date of progression as determined by the investigator at local site per RECIST 1.1, or death due to any cause, Part 2: DoR defined as time from the date of first documented response (which is subsequently confirmed) until the date of documented progression or death in the absence of disease progression, Part 2: OS defined as time from the date of first dose until the date of death by any cause, Serum concentration of T-DXd, total anti-HER2 antibody and MAAA- 1181a, Serum concentration of durvalumab, Immunogenicity of T-DXd and durvalumab

Countries

Belgium

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026