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Trial Title:
Study of ADCs Combined With Adebrelimab in HER2-negative Advanced Breast Cancer
NCT ID:
NCT06433609
Condition:
Advanced Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
SHR-A1811
Description:
Via intravenous infusion
Arm group label:
SHR-A1811+adebrelimab
Intervention type:
Drug
Intervention name:
SHR-A1921
Description:
Via intravenous infusion
Arm group label:
SHR-A1921+adebrelimab
Intervention type:
Drug
Intervention name:
Adebrelimab
Description:
Via intravenous infusion
Arm group label:
SHR-A1811+adebrelimab
Arm group label:
SHR-A1921+adebrelimab
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.
Criteria for 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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Beijing GoBroad Hospital
Address:
City:
Beijing
Zip:
102200
Country:
China
Contact:
Last name:
Yang Ke
Phone:
+86-13592618724
Email:
key3@gobroadhealthcare.com
Investigator:
Last name:
Yang Ke
Email:
Principal Investigator
Start date:
June 2024
Completion date:
November 2027
Lead sponsor:
Agency:
Beijing GoBroad Hospital
Agency class:
Other
Source:
Beijing GoBroad Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06433609
