Study of SHR-A1921 Combined Adebrelimab in HR-positive, HER2-negative Advanced Breast Cancer

NCT06470672 | Not Yet Recruiting Phase 2

• 1 other identifier: BC-MUL-IIT-SHRA1921-SHR1316
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

Our study is aimed to evaluate the efficacy and safety of novel ADC named SHR-A1921 combined with Adebrelimab in endocrine therapy-failed HR (Hormone Receptor)-positive, HER2-negative advanced breast cancer.

Conditions

Advanced Breast Cancer; Hormone-receptor-positive Breast Cancer; Human Epidermal Growth Factor 2 Negative Carcinoma of Breast

Outcome Measures

Primary Outcomes (1)

• ORR by investigator

  ORR (Objective response rate) is the percentage of evaluable patients with a confirmed investigator-assessed response of CR (complete response) or PR (partial response) per RECIST v1.1.

  At baseline, at the time point of every 6 weeks, up to 2 years

Secondary Outcomes (5)

• DCR by investigator

  At baseline, at the time point of every 6 weeks, up to 2 years

• DoR (Duration of Response)

  Up to 2 years

• PFS (Progression-Free Survival)

  Up to 2 years

• OS (Overall Survival)

  Up to 2 years

• Safety (incidence rate of adverse event)

  From time of informed consent provided to 3 months after the last dose of study therapy

Study Arms (1)

SHR-A1921+Adebrelimab

EXPERIMENTAL

Via intravenous infusion

Drug: SHR-A1921; Drug: Adebrelimab

Interventions

SHR-A1921 DRUG

Anti-TROP-2 ADC

SHR-A1921+Adebrelimab

Adebrelimab DRUG

PD-L1 inhibitor

SHR-A1921+Adebrelimab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years to 75 years old, female patients with breast cancer;
• ECOG PS Score: 0\~1;
• Histologically or cytologically confirmed HR-positive, HER2-negative advanced or metastatic breast cancer;
• PD-L1 positive;
• Disease progression after at least prior 2 lines of endocrine therapy, and unable to benefit from further endocrine therapy determined by investigator, of which at least one line of CDK4/6 inhibitor-based treatment; if recurrence or metastasis within 2 years after completion of adjuvant endocrine therapy, marked as first-line treatment;
• Prior at least 1 line of systemic chemotherapy in recurrent or metastatic setting;
• Based on RECIST v1.1, at least one measurable lesion;
• Patients must have a life expectancy ≥ 3 months;
• Adequate organ function and marrow function (no corrective treatment within 14 days before first dose);
• Women of childbearing potential (WOCBP) should agree to use an effective method of contraception and no lactation from the initiation of screening to 7 months after the last dose of study therapy; WOCBP should have a negative serum pregnancy result within 7 days before the first dose of study therapy;
• Willing and able to provide written informed consent and comply with the requirements and restrictions in the protocol.

You may not qualify if:

• Has leptomeningeal metastasis confirmed by MRI or lumbar puncture;
• Has CNS metastasis confirmed by radiology, except following conditions: ①asymptomatic brain metastasis that is not required to radiotherapy or surgery immediately; ②prior local therapy (e.g. radiotherapy or surgery) for brain or dural metastasis, of which stable disease lasting at least 4 weeks confirmed by radiography, and symptomatic therapy (e.g. hormone, mannitol, bevacizumab) has been stopped beyond 2 weeks with no clinical symptom;
• Prior anti-TROP-2 treatment;
• Has received or been receiving PD-(L)1 inhibitors and/or ADC containing a topoisomerase inhibitor-like payload;
• Existence of third space fluid (e.g. massive ascites, pleural effusion, pericardial effusion) that is not well controlled by effective methods, e.g. drainage;
• 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;
• Use of other antitumor systemic treatment during the study;
• Has active autoimmune disease or a history of autoimmune disease;
• Known history of immunodeficiency, including HIV-positive, other acquired or innate immunodeficient disease, or known history of organ transplantation;
• 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;
• 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);
• 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;
• 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;
• Hypersensitivity to study therapy or any of its excipients;
• Has known clinically significant lung disease, including but not limited to: interstitial lung disease, pneumonitis, pulmonary fibrosis;

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan Cancer Hospital

Shanghai, Shanghai Municipality, 200230, China

Location

Study Officials

• Hongxia Wang

  Fudan Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hongxia Wang

CONTACT

+8621-38196379; whx365@126.com

Zhonghua Tao

CONTACT

+86-13774315805; drtaozhh@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: June 18, 2024
• First Posted: June 24, 2024
• Study Start: December 1, 2024
• Primary Completion: March 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: December 20, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)