Study of ADCs Combined With Adebrelimab in HER2-negative Advanced Breast Cancer

NCT ID: NCT06433609

Last Updated: 2024-05-30

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 131 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-30
• Study Completion Date: 2027-11-30

Brief Summary

Our study is aimed to evaluate the efficacy and safety of novel ADCs named SHR-A1811 and SHR-A1921 combined with adebrelimab in HER2-negative advanced breast cancer.

Conditions

Advanced Breast Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SHR-A1811+adebrelimab

Group Type: EXPERIMENTAL

SHR-A1811

Intervention Type: DRUG

Via intravenous infusion

Adebrelimab

Intervention Type: DRUG

Via intravenous infusion

SHR-A1921+adebrelimab

Group Type: EXPERIMENTAL

SHR-A1921

Intervention Type: DRUG

Via intravenous infusion

Adebrelimab

Intervention Type: DRUG

Via intravenous infusion

Interventions

SHR-A1811

Via intravenous infusion

Intervention Type: DRUG

SHR-A1921

Via intravenous infusion

Intervention Type: DRUG

Adebrelimab

Via intravenous infusion

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. 18 years to 75 years old (including boundary values), female patients with breast cancer;

2. ECOG PS Score: 0~1;

3. Histologically or cytologically confirmed HER2-negative advanced breast cancer;

4. Disease progression after prior 1-2 lines of systemic therapy; if HR-positive, prior CDK4/6 inhibitor is necessary;

5. Based on RECIST v1.1, at least one measurable lesion;

6. Brain metastasis with no clinical symptoms, or treated, stable brain metastases are eligible;

7. No prior PD-(L)1 inhibitor;

8. Patients must have a life expectancy ≥ 6 months;

9. Adequate organ function and marrow function (no corrective treatment within 14 days before first dose);

10. Patients of childbearing potential should have a negative urine or serum pregnancy, and must promise to use an adequate method of contraception starting with the first dose of study therapy through 6 months after the last dose of study therapy or be celibate;

11. Available blood samples for ctDNA detection in the exploratory study;

12. Willing and able to provide written informed consent and comply with the requirements and restrictions in the protocol.

Exclusion Criteria

1. Has known active brain metastasis which needs local therapy immediately;

2. Prior anti-HER2 or anti-TROP-2 treatment;

3. Has received or been receiving PD-(L)1 inhibitors and/or ADC containing a topoisomerase inhibitor-like payload;

4. Existence of third space fluid that is not well controlled by effective methods, e.g. drainage;

5. Has received antitumor surgery, radiotherapy, chemotherapy, targeted therapy or immunological therapy within 4 weeks before first dose of study therapy; has received antitumor endocrine therapy within one week before first dose of study therapy;

6. Use of other antitumor systemic treatment during the study;

7. Has active autoimmune disease or a history of autoimmune disease;

8. Known history of immunodeficiency, including HIV-positive, other acquired or innate immunodeficient disease, or known history of organ transplantation;

9. Has active hepatitis B (HBsAg-positive and HBV DNA≥500 IU/mL), hepatitis C (positive for HCV antibody and HCV RNA above ULN) and hepatic cirrhosis;

10. Has an active infection requiring antibiotics, antiviral or antifungal treatment, or pyrexia >38.5℃ of unknown origin during the screening period before first dose of study therapy (patients with pyrexia due to cancer could be enrolled determined by investigator);

11. Receiving immunosuppressive medication, or systemic corticosteroid therapy for the purpose of immunosuppression (prednisone at >10mg/d or equivalent dose of other corticosteroids), and continuous use within 2 weeks before the first dose of study therapy;

12. Other malignancy within prior 5 years unless curatively treated with no evidence of disease for at least recent 3 years, except: curatively treated in situ cancer of the cervix, skin basal cell carcinoma or skin squamous cell carcinoma;

13. Hypersensitivity to study therapy or any of its excipients;

14. Has known clinically significant lung disease, including but not limited to: interstitial lung disease, pneumonitis, pulmonary fibrosis;

15. Known history of uncontrolled cardiovascular clinical symptom or disease that is not well controlled;

16. Has received a live vaccine within 4 weeks before first dose of study therapy, or potential to receive a live vaccine during the trial treatment;

17. Patients with a positive serum or urine pregnancy test or who are breastfeeding; patients of childbearing potential who are unwilling or not available to use an effective method of contraception;

18. Other conditions that might influence the study and analysis of results in the opinion of the investigator.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Beijing GoBroad Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yang Ke

Associate chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yang Ke

Role: PRINCIPAL_INVESTIGATOR

Beijing GoBroad Hospital

Locations

Beijing GoBroad Hospital

Beijing, Beijing Municipality, China

Countries

China

Central Contacts

Yang Ke

Role: CONTACT

key3@gobroadhealthcare.com

+86-13592618724

Facility Contacts

Yang Ke

Role: primary

key3@gobroadhealthcare.com

+86-13592618724

Other Identifiers

BC-MUL-IIT-ADC-SHR1316

Identifier Type: OTHER

Identifier Source: secondary_id

BJGBYY-IIT-LCYJ-2024-008

Identifier Type: -

Identifier Source: org_study_id