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

NCT06433609 | Not Yet Recruiting Phase 2

• 2 other identifiers: BJGBYY-IIT-LCYJ-2024-008BC-MUL-IIT-ADC-SHR1316
• Study Type: interventional
• Target: 131
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• ORR (objective response rate) by investigator

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

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3.5 years

Secondary Outcomes (6)

• DCR (disease control rate) by investigator

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3.5 years

• CBR (clinical benefit rate) by investigator

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3.5 years

• DoR (duration of response)

  up to 3.5 years

• PFS (progression-free survival)

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3.5 years

• OS (overall survival)

  up to 3.5 years

Study Arms (2)

SHR-A1811+adebrelimab

EXPERIMENTAL

Drug: SHR-A1811; Drug: Adebrelimab

SHR-A1921+adebrelimab

EXPERIMENTAL

Drug: SHR-A1921; Drug: Adebrelimab

Interventions

SHR-A1811 DRUG

Via intravenous infusion

SHR-A1811+adebrelimab

SHR-A1921 DRUG

Via intravenous infusion

SHR-A1921+adebrelimab

Adebrelimab DRUG

Via intravenous infusion

SHR-A1811+adebrelimab; 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 (including boundary values), female patients with breast cancer;
• ECOG PS Score: 0\~1;
• Histologically or cytologically confirmed HER2-negative advanced breast cancer;
• Disease progression after prior 1-2 lines of systemic therapy; if HR-positive, prior CDK4/6 inhibitor is necessary;
• Based on RECIST v1.1, at least one measurable lesion;
• Brain metastasis with no clinical symptoms, or treated, stable brain metastases are eligible;
• No prior PD-(L)1 inhibitor;
• Patients must have a life expectancy ≥ 6 months;
• Adequate organ function and marrow function (no corrective treatment within 14 days before first dose);
• 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;
• Available blood samples for ctDNA detection in the exploratory study;
• Willing and able to provide written informed consent and comply with the requirements and restrictions in the protocol.

You may not qualify if:

• Has known active brain metastasis which needs local therapy immediately;
• Prior anti-HER2 or 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 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;
• Known history of uncontrolled cardiovascular clinical symptom or disease that is not well controlled;

Sponsors & Collaborators

• Beijing GoBroad Hospital: lead

Study Sites (1)

Beijing GoBroad Hospital

Beijing, Beijing Municipality, 102200, China

Location

Study Officials

• Yang Ke

  Beijing GoBroad Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yang Ke

CONTACT

+86-13592618724; key3@gobroadhealthcare.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate chief physician

Study Record Dates

• First Submitted: May 23, 2024
• First Posted: May 30, 2024
• Study Start: June 1, 2024
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: May 30, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)