Study of SHR-A2102 Combined Other Antitumor Drugs in Advanced Breast Cancer

NCT07041437 | Not Yet Recruiting Phase 2

• 1 other identifier: BC-MUL-IIT-SHRA2102
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

Our study is aimed to evaluate the efficacy and safety of SHR-A2102 combined other antitumor treatments in advanced breast cancer.

Conditions

Advanced Breast Cancer

Outcome Measures

Primary Outcomes (1)

• ORR 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 and will be evaluated at baseline, at the time point of every 6 weeks.

  At baseline, at the time point of every 6 weeks

Secondary Outcomes (5)

• DCR by investigator

  At baseline, at the time point of every 6 weeks

• DoR

  up to 2 years

• PFS

  up to 2 years

• OS

  up to 2 years

• Percentage of participants who experience an adverse event [Safety and Tolerability]

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

Study Arms (2)

SHR-A2102

EXPERIMENTAL

Single Agent

Drug: SHR-A2102

SHR-A2102+adebrelimab

EXPERIMENTAL

SHR-A2102 combined with adebrelimab

Drug: SHR-A2102; Drug: Adebrelimab

Interventions

SHR-A2102 DRUG

ADC

SHR-A2102; SHR-A2102+adebrelimab

Adebrelimab DRUG

PD-L1 inhibitor

SHR-A2102+adebrelimab

Eligibility Criteria

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

You may qualify if:

• years to 75 years old (including boundary values), patients with advanced or metastatic breast cancer;
• ECOG PS Score: 0\~1;
• 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; if unneutered male subjects (including using other sterilization except bilateral orchidectomy \[e.g. vasectomy\]) are willing to have sexual behaviour with WOCBP, one kind of contraception must be used to prevent the pregnancy of his partner from the date of enrolment to 7 months after the last 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:

• Active brain metastasis; Stable brain metastasis (at least 4 weeks after intracranial local treatment, subjects should meet one of the following requirements: a. no signs of disease progression confirmed by imaging; b. no clinical symptom, and not necessary to corticosteroid or anticonvulsant therapy; c. with clinical symptom, but not necessary to increase dose of corticosteroid or combine with dexamethasone to control clinical symptom compared with intracranial local treatment) is allowed to be enrolled;
• Existence of third space fluid (e.g. massive ascites, pleural effusion, pericardial effusion which needs drainage again to relieve symptoms within 4 weeks after the first drainage) which is not well controlled by effective methods, e.g. drainage;
• Other malignancy within prior 2 years with no necessary treatment (except hormone replacement treatment) for at least recent 2 years, except: curatively treated in situ cancer of the cervix, skin basal cell carcinoma, skin squamous cell carcinoma or papillary thyroid carcinoma;
• 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;
• Adverse events caused by prior antitumor therapy have not recovered to ≤grade 1 per NCI-CTCAE v5.0 (except alopecia and tolerable, chronic grade 2 toxicity determined by investigator);
• Use of other antitumor systemic treatment during the study;
• Has received CYP3A4, CYP2D6, P-gp or BCRP potent inhibitors or inducers \<5-fold half-life of the drug before the first dose;
• 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 immunodeficiency, including HIV-positive, other acquired or innate immunodeficient disease, or known history of organ transplantation, or known history of allogenic haemopoietic stem cell 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);
• Known severe cardiac-cerebral vascular disease, including but not limited to: a) known severe cardiac rhythm or conduction disorder, such as ventricular arrhythmias necessary for clinical intervention, second or third degree atrioventricular block; b) under the resting state, QTcF\>470ms for female or 450ms for male examined by 12-lead ECG; c) acute coronary syndrome, congestive heart failure (NYHA classification of heart failure ≥ Class II), myocardial infarction, aortic dissection, cerebral stroke, or other ≥grade 3 cardiac-cerebral vascular events; d) LVEF\<50%; e) clinically uncontrolled hypertension;
• Existence of arterial/venous thrombotic event within 6 months before first dose, such as cerebrovascular accidents (including transient ischemic attack, cerebral haemorrhage and cerebral infarction), deep venous thrombosis and pulmonary embolism;
• (Arm 2 only) Has received or been receiving PD-1/PD-L1 inhibitor;

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan Cancer Hospital

Shanghai, Shanghai Municipality, 200230, China

Location

Study Officials

• Hongxia Wang, Chief physician

  Fudan University

  PRINCIPAL INVESTIGATOR

• Xichun Hu, Chief physician

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hongxia Wang, Chief physician

CONTACT

+862138196379; whx365@126.com

Zhonghua Tao, Chief physician

CONTACT

+86-13774315805; drtaozhh@126.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: Chief physician

Model Details: Two arms of SHR-A2102 based-treatment will be enrolled to evaluate efficacy and safety, but this is a nonrandomized design.

Study Record Dates

• First Submitted: June 19, 2025
• First Posted: June 27, 2025
• Study Start: June 30, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: June 27, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)