Study of SHR-A1811 Combined With Pyrotinib and Bevacizumab in Advanced Breast Cancer With Brain Metastasis

Sponsor
Fudan University
Study ID
NCT06718933
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Breast Cancer Brain Metastases
  • Breast Cancer Metastatic

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • SHR-A1811 — DRUG
    ADC
  • Bevacizumab — DRUG
    bevacizumab biosimilar
  • Pyrotinib — DRUG
    anti-HER2 inhibitor

Study Details

In phase Ib, our study is aimed to evaluate the safety and tolerance of SHR-A1811 combined with pyrotinib in breast cancer with brain metastasis, and confirm the recommended phase 2 dose combined with preliminary results of efficacy. In phase II, our study is aimed to evaluate the efficacy and safety of SHR-A1811 combined with pyrotinib and bevacizumab at RP2D in breast cancer with brain metastasis.

Key Dates

First listed
Dec 5, 2024
Start date
Jan 8, 2025
Status verified
Nov 2024
Primary completion
Aug 31, 2026
Completion
Feb 28, 2027

Study Design

Enrollment
74 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: SHR-A1811+pyrotinib
    In phase Ib, enrolled subjects will received SHR-A1811 combined with pyrotinib at different doses to confirm RP2D and evaluate the safety and tolerance.
  • Experimental: SHR-A1811+pyrotinib+bevacizumab
    In phase II, enrolled subjects will received SHR-A1811 combined with pyrotinib and bevacizumab to evaluate the efficacy and safety.

Primary Outcome Measure

RP2D in phase Ib [ Time Frame: From the enrolment of the first subject, to the end of Cycle 6 completion or disease progression or dose discontinuation due to AE in the last enrolled subject ]

Central Contacts

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