A Study of SHR-A1811 Combined With Capecitabine in Treatment of Unresectable or Metastatic Breast Cancer With Low HER2 Expression.

July 27, 2023 updated by: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

An Open-Label, Multi-center Phase Ⅰb/Ⅱ Study of SHR-A1811 Combined With Capecitabine in Treatment of Unresectable or Metastatic Breast Cancer With Low HER2 Expression.

The study is being conducted to evaluate the safety, tolerability， preliminary efficacy, pharmacokinetics, and immunogenicity of SHR-A1811 combined with capecitabine in treatment of unresectable or metastatic breast cancer with low HER2 expression.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

116

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China, 230000
        • Not yet recruiting
        • The second hospital of Anhui medical university
        • Principal Investigator:
          • Fanfan Li
    • Beijng
      • Beijing, Beijng, China, 100000
        • Recruiting
        • Cancer Hospital Chinese Academy of Medical Sciences
        • Principal Investigator:
          • Fei Ma
    • Guangxi
      • Nanning, Guangxi, China, 530000
        • Not yet recruiting
        • Guangxi Medical University Affiliated Tumor Hospital & Oncology Medical College
        • Principal Investigator:
          • Qinguo Mo
    • Guangzhou
      • Shantou, Guangzhou, China, 515000
        • Not yet recruiting
        • Shantou Central Hospital
        • Principal Investigator:
          • Zhiyong Wu
    • Henan
      • Zhengzhou, Henan, China, 450000
        • Recruiting
        • Henan Provincial People's Hospital
        • Principal Investigator:
          • Pilei Si
    • Jiangsu
      • Nanjing, Jiangsu, China, 210000
        • Not yet recruiting
        • The First Affiliated Hospital with Nanjing Medical University
        • Principal Investigator:
          • Yongmei Yin
    • Liaoning
      • Shenyang, Liaoning, China, 110000
        • Not yet recruiting
        • The First Hospital of China Medical University
        • Principal Investigator:
          • Yuee Teng
    • Shandong
      • Jinan, Shandong, China, 250000
        • Not yet recruiting
        • Shandong Cancer Hospital&Institute
        • Principal Investigator:
          • Huihui Li
    • Zhejiang
      • Wenzhou, Zhejiang, China, 325000
        • Not yet recruiting
        • Wenzhou People's Hospital
        • Principal Investigator:
          • Miaoyong Zhu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Women aged 18 to 75 (inclusive).
  2. HER2 low expression unresectable or metastatic breast cancer confirmed by histology or cytology.
  3. ECOG score is 0 or 1.
  4. An expected survival of ≥ 12 weeks.
  5. At least one measurable lesion according to RECIST v1.1 criteria.
  6. Women of childbearing potential (WOCBP) subjects must agree to use highly effective contraception for 7 months from the start of study screening until the last study medication and agree not to breastfeeding.
  7. Patients voluntarily joined the study and signed informed consent, had good compliance and willingness to cooperate with the visit and study related procedures.

Exclusion Criteria:

  1. Have other malignancies within the past 5 years.
  2. Presence with uncontrollable third space effusion.
  3. Have surgical treatment, radiotherapy, chemotherapy, immunotherapy, molecular targeted therapy, biological therapy or other drug clinical studies within 4 weeks before the first medication.
  4. Accepted antibody drug conjugates containing etoisomercan derivative topoisomerase I inhibitor.
  5. Clinically significant cardiovascular disorders.
  6. Presence of active hepatitis B, hepatitis C, cirrhosis,or serious infected persons requiring antibiotic, antiviral or antifungal control.
  7. The toxicity from previous anti-tumor treatment has not recovered to ≤ grade I.
  8. Known to be allergic to any study drug or any of its excipients, or to humanized monoclonal antibody products.
  9. Failure to swallow, chronic diarrhea, intestinal obstruction, or presence of other factors affecting drug administration and absorption.
  10. Presence of other serious physical or mental diseases or laboratory abnormalities.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SHR-A1811 combined with capecitabine
Drug: SHR-A1811 for injection ; capecitabine
SHR-A1811 for injection; Capecitabine tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
DLT（Phase I (dose exploration phase) ） [ Time Frame: 21 days after the first administration of each subject ]
Time Frame: 21 days after the first administration of each subject ]
21 days after the first administration of each subject ]
Incidence of AEs（Phase I (dose exploration phase) ）
Time Frame: from Day1 to 40 days after last dose
from Day1 to 40 days after last dose
Incidence of SAEs（Phase I (dose exploration phase) ）
Time Frame: from Day1 to 40 days after last dose
from Day1 to 40 days after last dose
Objective response rate（Phase II (efficacy expansion phase)）
Time Frame: One year after the last subject was enrolled in the group
One year after the last subject was enrolled in the group

Secondary Outcome Measures

Outcome Measure
Time Frame
Duration of response(DoR )
Time Frame: One year after the last subject was enrolled in the group
One year after the last subject was enrolled in the group
Progression Free Survival(PFS)
Time Frame: One year after the last subject was enrolled in the group
One year after the last subject was enrolled in the group
Objective response rate（Phase I (dose exploration phase)）
Time Frame: One year after the last subject was enrolled in the group
One year after the last subject was enrolled in the group
Incidence of AEs（Phase II (efficacy expansion phase)）
Time Frame: from Day1 to 40 days after last dose
from Day1 to 40 days after last dose
Incidence of SAEs（Phase II (efficacy expansion phase)）
Time Frame: from Day1 to 40 days after last dose
from Day1 to 40 days after last dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 25, 2023

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

April 18, 2023

First Submitted That Met QC Criteria

May 4, 2023

First Posted (Actual)

May 6, 2023

Study Record Updates

Last Update Posted (Actual)

August 1, 2023

Last Update Submitted That Met QC Criteria

July 27, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHR-A1811-207

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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