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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

BrAin Metastasis in tripLe Negateive Breast Cancer: IvoneScimab and Trop2 ADC

Prospective, One-arm, Phase II Clinical Study of Ivoximab Combined With TROP2 ADC in the Treatment of Brain Metastases in Triple-negative Breast Cancer

BrAin Metastasis in tripLe Negateive Breast Cancer: IvoneScimab and Trop2 ADC (NCT06793332) is a Phase 2 interventional studying Triple-Negative Breast Cancer (TNBC) and Brain Metastases, sponsored by Fudan University. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

This study is a single-center, prospective, single-arm clinical trial, which intends to enroll patients with triple-negative breast cancer with brain metastases to receive ivonescimab combined with TROP2 ADC (such as sacituzumab govitecan) treatment until disease progression, intolerable toxicity, withdrawal of informed consent, or the investigator deems it necessary to discontinue the medication, and to collect data on the drug's efficacy and safety.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Triple-Negative Breast Cancer (TNBC) and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 39 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Age ≥ 18 years and ≤ 70 years, with no gender restrictions; 2. ECOG performance score of 0 to 2; 3. Expected survival ≥ 3 months; 4. Patients with unresectable locally advanced, recurrent or metastatic triple-negative breast cancer who have failed treatment with taxane drugs are included. 5. Ten tissue pathology slides of the primary lesion and/or metastatic lesion (preferably metastatic lesion) can be obtained before the start of treatment for exploratory analysis of molecular indicators related to therapeutic efficacy. 6. Patients must have brain metastases confirmed by MRI, with at least one brain metastasis lesion that previously has not received radiotherapy and has a longest diameter of ≥ 1.0 cm; for brain metastasis lesions that have received local treatment, progression must be confirmed by imaging examination; 7. Cohort A: Patients with brain metastases who have not received central nervous system radiotherapy before. Patients with new brain lesions after craniotomy are allowed to be included, provided that they have not received radiotherapy after surgery and at least 2 weeks have passed since the surgery; 8. Cohort B: Patients with lesion progression or new lesions after whole brain radiotherapy (WBRT) or stereotactic radiotherapy (SRT). If a patient has multiple central nervous system lesions and only one or a few of them have received SRT treatment, and there are untreated lesions, such patients are still eligible for inclusion in this study; 9. The use of mannitol or hormones for treatment is allowed before enrollment, but the hormone treatment dose should be stable for at least one week without the need for an increase; 10. All patients enrolled are required to have adequate hematologic, hepatic, and renal function; 11. Be able to understand the study procedures and sign willing to sign a consent form. Who Should NOT Join This Trial: 1. Patients with soft meningeal metastases confirmed by MRI or lumbar puncture; ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Age ≥ 18 years and ≤ 70 years, with no gender restrictions; 2. ECOG performance score of 0 to 2; 3. Expected survival ≥ 3 months; 4. Patients with unresectable locally advanced, recurrent or metastatic triple-negative breast cancer who have failed treatment with taxane drugs are included. 5. Ten tissue pathology slides of the primary lesion and/or metastatic lesion (preferably metastatic lesion) can be obtained before the start of treatment for exploratory analysis of molecular indicators related to therapeutic efficacy. 6. Patients must have brain metastases confirmed by MRI, with at least one brain metastasis lesion that previously has not received radiotherapy and has a longest diameter of ≥ 1.0 cm; for brain metastasis lesions that have received local treatment, progression must be confirmed by imaging examination; 7. Cohort A: Patients with brain metastases who have not received central nervous system radiotherapy before. Patients with new brain lesions after craniotomy are allowed to be included, provided that they have not received radiotherapy after surgery and at least 2 weeks have passed since the surgery; 8. Cohort B: Patients with lesion progression or new lesions after whole brain radiotherapy (WBRT) or stereotactic radiotherapy (SRT). If a patient has multiple central nervous system lesions and only one or a few of them have received SRT treatment, and there are untreated lesions, such patients are still eligible for inclusion in this study; 9. The use of mannitol or hormones for treatment is allowed before enrollment, but the hormone treatment dose should be stable for at least one week without the need for an increase; 10. All patients enrolled are required to have adequate hematologic, hepatic, and renal function; 11. Be able to understand the study procedures and sign informed consent. Exclusion Criteria: 1. Patients with soft meningeal metastases confirmed by MRI or lumbar puncture; 2. Presence of third-space effusion that cannot be controlled by drainage or other methods (such as large amounts of pleural effusion and ascites); 3. Received whole brain radiotherapy, chemotherapy, or surgery within 2 weeks before the treatment with the investigational drug, or received targeted therapy or endocrine therapy within 1 week before the treatment; 4. Previously used monoclonal or bispecific antibodies containing anti-VEGF-A and anti-PD-1/PD-L1/CTLA-4; previously used TROP2 ADC drugs. 5. Participated in other drug clinical trials within 2 weeks before enrollment; 6. Simultaneously receiving any anti-tumor treatment for other tumors; 7. Had other malignant tumors within the past 5 years, excluding cervical carcinoma in situ, basal cell carcinoma or squamous cell carcinoma of the skin, differentiated thyroid cancer, etc. that have been cured; 8. Patients with severe heart diseases, including: (1) Congestive heart failure (NYHA class \> 2); (2) History of unstable angina pectoris; (3) Myocardial infarction within the past 48 weeks; (4) Clinically significant arrhythmias (excluding atrial fibrillation and paroxysmal supraventricular tachycardia); (5) Any other heart diseases deemed by the investigator as unsuitable for participation in this trial; 9. Known hypersensitivity to the components of the investigational drug; 10. Uncontrolled serious infection. 10\. History of immunodeficiency, including HIV positive, active hepatitis C virus infection or other acquired or congenital immunodeficiency diseases, or history of organ transplantation; patients with positive hepatitis B surface antigen (HBsAg) and HBV DNA \> 2000 IU/ml or \> 104 copies/ml should receive antiviral treatment according to local treatment guidelines and be willing to receive antiviral treatment throughout the study period; 11. Use of live attenuated vaccines within 28 days before randomization, or expected to use such vaccines during the study period (patients are not allowed to receive live attenuated influenza vaccine within 4 weeks before randomization, during treatment, and within 5 months after the last dose of SHR-1316/placebo); 12. Active, known or suspected autoimmune diseases, including but not limited to myasthenia gravis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, etc. Type 1 diabetes (controlled by insulin), hypothyroidism due to autoimmune thyroiditis that only requires hormone replacement therapy, or conditions that are not expected to recur without external stimulation are allowed. Patients with eczema, psoriasis, chronic simple lichen or only with skin manifestations of vitiligo (excluding psoriatic arthritis) can be enrolled if the rash covers less than 10% of the body surface area, the disease is well controlled at baseline and only requires low-potency topical steroids, and there has been no acute exacerbation of the underlying disease in the past 12 months (no need for psoralen plus ultraviolet radiation \[PUVA\], methotrexate, retinoids, biologics, oral calcineurin inhibitors, high-potency or oral steroids); 13. History of definite neurological or mental disorders, including epilepsy or dementia; 14. Pregnant or lactating women, women of childbearing age with positive baseline pregnancy test, or women who are unwilling to take effective contraceptive measures throughout the study period; 15. According to the investigator's judgment, patients with severe concomitant diseases that may endanger their safety or affect their completion of the study (including but not limited to uncontrolled severe hypertension, severe diabetes, active infection, thyroid disease, etc.); 16. Any other conditions deemed by the investigator as unsuitable for participation in this study.

Treatments Being Tested

DRUG

Ivonescimab Combined With TROP2 ADC

Ivonescimab: 20 mg/kg, ivggt, day 1, every 3 weeks; Sacituzumab govitecan: 10 mg/kg, ivggt, day 1 and day 8, every 3 weeks;

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Fudan University Shanghai Cancer center
Shanghai, Shanghai Municipality, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06793332), the sponsor (Fudan University), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06793332 clinical trial studying?

This study is a single-center, prospective, single-arm clinical trial, which intends to enroll patients with triple-negative breast cancer with brain metastases to receive ivonescimab combined with TROP2 ADC (such as sacituzumab govitecan) treatment until disease progression, intolerable toxicity, withdrawal of informed consent, or the investigator deems it necessary to discontinue the medication, and to collect data on the drug's efficacy and safety. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06793332?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06793332?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06793332. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06793332. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.