NCT05824325

Brief Summary

This is a phaseⅠb/Ⅱ, open-label, two-arm parallel study evaluating the efficacy and safety of different targeted antibody-drug conjugates for HER2 ultra-low or no expression advanced breast cancer

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P50-P75 for phase_1 breast-cancer

Timeline
6mo left

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress88%
Mar 2023Oct 2026

First Submitted

Initial submission to the registry

March 5, 2023

Completed
9 days until next milestone

Study Start

First participant enrolled

March 14, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 21, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2025

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2026

Expected
Last Updated

June 27, 2023

Status Verified

June 1, 2023

Enrollment Period

2.1 years

First QC Date

March 5, 2023

Last Update Submit

June 25, 2023

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (2)

  • Occurrence of adverse events (AEs)- Phase 1

    Occurrence of AEs in Phase 1 graded according to CTCAE v5.0

    Up to follow-up period, approximately 24 months

  • Objective Response Rate (ORR)- Phase 2

    The proportion of patients who have a CR or PR, as determined by the Investigator at local site per RECIST 1.1.

    Until progression, assessed up to approximately 24 months

Secondary Outcomes (7)

  • Progression Free Survival (PFS

    Until progression, assessed up to approximately 24 months

  • Overall Survival (OS)

    Until death, assessed up to approximately 24 months

  • Duration of Response (DoR)

    Until progression, assessed up to approximately 24 months

  • Disease Control Rate (DCR)

    Baseline through end of study, assessed up to 24 months

  • Clinical Benefit Rate (CBR)

    Until progression or death, assessed up to approximately 24 months

  • +2 more secondary outcomes

Study Arms (2)

Experimental: HER2 ADC

EXPERIMENTAL

Patients diagnosed with HER2 ultra-low or no expression are recruited

Drug: SHR-A1811

Experimental: TROP2 ADC

EXPERIMENTAL

Patients diagnosed with HER2 ultra-low or no expression are recruited.

Drug: TROP2 ADC

Interventions

SHR-A1811DRUG

HER2 ADC

Experimental: HER2 ADC
TROP2 ADCDRUG

TROP2 ADC

Experimental: TROP2 ADC

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ECOG Performance Status of 0 or 1
  • Pathologically documented breast cancer that:
  • is advanced or metastatic
  • is histologically confirmed to be HER2 IHC 0 (ISH- or untested)
  • was never previously HER2-positive (IHC 3+ or ISH+) At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1.
  • Disease progression on at least 1 previous line of chemotherapy for recurrent/metastatic breast cancer. Subjects with HER2-negative and hormone-receptor positive tumors must have progressed after at least 1 line of endocrine therapy with or without CDK4/6 inhibitor.
  • Has protocol-defined adequate organ and bone marrow function. Ability to understand and willingness to sign a written informed consent document.

You may not qualify if:

  • Has previously been treated with any anti-HER2 therapy. Known prior severe hypersensitivity to investigational product or any component in its formulation and other monoclonal antibodies.
  • Any major surgery, radiotherapy, chemotherapy, immunotherapy or molecular targeted therapy, biotherapy or other drug clinical trial within 4 weeks; received endocrine therapy within 2 weeks before the first study drug administration.
  • History of other malignancy than breast cancer within 5 years prior to screening (except for cured skin basal cell carcinoma and cervical carcinoma in situ).
  • Meningeal metastasis or active brain parenchymal metastasis. Any concurrent use of immunosuppressant or systemic corticosteroid treatment to achieve immunosuppression purpose (dose of \> 10mg/day prednisone or equivalent), and still in use within 2 weeks before the first study drug administration.
  • Has uncontrolled intercurrent illness or significant cardiovascular disease. History of clinically significant lung diseases. History of immunodeficiency, including HIV positive. Known active hepatitis B virus or hepatitis C virus infection. Has any medical history or condition that per protocol or in the opinion of the investigator is inappropriate for the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Physician

Study Record Dates

First Submitted

March 5, 2023

First Posted

April 21, 2023

Study Start

March 14, 2023

Primary Completion

April 10, 2025

Study Completion (Estimated)

October 10, 2026

Last Updated

June 27, 2023

Record last verified: 2023-06

Locations

CN(1)