SHR-A1811 in Combination With Adebrelimab for the Treatment of HER2 Low-expressing Metastatic Breast Cancer

NCT ID: NCT06411457

Last Updated: 2024-05-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-16
• Study Completion Date: 2026-05-01

Brief Summary

To evaluate the efficacy and safety of the SHR-A1811 in combination with Adebrelimab regimen in HER2 low-expressing metastatic breast cancer

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SHR-A1811+Adebrelimab

Assess the efficacy and safety of the SHR-A1811 in combination with Adebrelimab regimen in HER2 low-expressing metastatic breast cancer

Group Type: EXPERIMENTAL

SHR-A1811+Adebrelimab

Intervention Type: DRUG

Assess the efficacy and safety of the SHR-A1811 in combination with Adebrelimab regimen in HER2 low-expressing metastatic breast cancer SHR-A1811 : 6.4mg/kg , q3w，d1, ivgtt Adebrelimab : 1200mg, q3w，d1, ivgtt

Interventions

SHR-A1811+Adebrelimab

Assess the efficacy and safety of the SHR-A1811 in combination with Adebrelimab regimen in HER2 low-expressing metastatic breast cancer SHR-A1811 : 6.4mg/kg , q3w，d1, ivgtt Adebrelimab : 1200mg, q3w，d1, ivgtt

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Age ≥ 18 years; ER/PgR expression ≤10% and low HER2 expression (IHC 1+, or IHC 2+ and ISH-); Advanced breast cancer patients; Prior treatment with ≥1 line of therapy for localized recurrence or metastatic disease; At least one prior treatment with taxane or anthracycline therapy; Allowed to receive immunotherapy during neoadjuvant or adjuvant stages; Measurable lesions according to RECIST 1.1 standards; ECOG PS score: 0-1; Voluntary participation with good compliance; Negative pregnancy test result, childbearing-age participants commit to effective contraception from the study start to 6 months after the last dose; Adequate organ function; Blood routine: ANC ≥1.5×109/L, PLT≥70×109/L, HGB ≥90g/L; Liver function: TBIL ≤1.5×ULN, ALT and AST ≤3×ULN, serum albumin ≥28 g/L, ALP ≤5×ULN; Stable liver function for at least 1 week after routine liver protection treatment, as assessed by the investigator, is eligible for inclusion; Renal function: Cr ≤1.5×ULN, or CrCl ≥50 mL/min (using standard Cockcroft-Gault formula); Coagulation function: INR ≤1.5/PT ≤1.5×ULN, aPTT ≤1.5×ULN; Left ventricular ejection fraction ≥50%

Exclusion Criteria

• Active central nervous system metastases or carcinomatous meningitis (stable brain metastasis patients are allowed to participate); Prior treatment with anti-HER2 ADC drugs; Active autoimmune disease or history of autoimmune disease (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism; Patients with vitiligo; Childhood asthma completely resolved in adulthood without any intervention can be included, but asthma requiring bronchodilators for medical intervention in adulthood cannot be included); Patients using immunosuppressants or systemic steroid therapy for immunosuppressive purposes (dose>10mg/day prednisone or equivalent) in the 2 weeks before inclusion; Patients with other malignant tumors in the past or simultaneously; Grade ≥4 adverse reactions after ADC drug treatment, grade ≥3 immune-related adverse reactions; Known allergy to drug components used; Patients with known interstitial pneumonia; Poorly controlled clinical heart symptoms or diseases, such as: (1) NYHA class 2 or above heart failure; (2) unstable angina; (3) myocardial infarction within the past year; (4) patients with clinically significant ventricular or supraventricular arrhythmias requiring treatment or intervention; Active infection or unexplained fever >38.5°C during the screening period or before the first dose of study medication, depending on the investigator's judgment, patients with fever due to tumor can be included; Not receiving live vaccines within less than 4 weeks before or during the study; Patients known to have a history of psychiatric drug abuse, alcoholism, or drug addiction; Factors that may lead to the premature termination of the study judged by the investigator, such as other serious diseases (including mental illness) requiring concomitant treatment, severe laboratory abnormalities, family or social factors affecting patient safety, data and sample collection

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

QIAO LI

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Qiao Li, M.D.

Role: PRINCIPAL_INVESTIGATOR

National Cancer Center/Cancer Hospital

Locations

National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Qiao Li, M.D.

Role: CONTACT

liqiaopumc@qq.com

18500027849

Facility Contacts

Qiao Li, Dr.

Role: primary

liqiaopumc@qq.com

+8615910573527

Yue Chai, Dr.

Role: backup

cy972628990@163.com

13350804092

Other Identifiers

NCC4483

Identifier Type: -

Identifier Source: org_study_id