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TNBCPhase 2NCT07623577

Sac-TMT Combined With Bevacizumab in TNBC With Brain Metastases

A Phase 2 study testing Sacituzumab Tirumotecan (Sac-TMT) and bevacizumab in people with TNBC and Brain Metastasis, run by Fudan University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This is a single-arm, multi-center phase II study to evaluate the safety and efficacy Sacituzumab Tirumotecan (Sac-TMT) plus bevacizumab in triple-negative breast cancer patients with brain metastases. Twenty-four participants are planned to be enrolled. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
TNBC, Brain Metastasis
What is being tested?
Sacituzumab Tirumotecan (Sac-TMT) and bevacizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteChina
Study dates
1 Jan 2026to Dec 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years old, regardless of gender;
  • ECOG Performance Status of 0-2;
  • Histologically or cytologically confirmed HR-negative and HER2-negative breast cancer; there is evidence of metastasis; not suitable with curative surgery or radiation therapy; HR negative is defined as: ER-negative and PR-negative, the proportion of positively stained tumor cells in all tumor cells is < 10%; HER2- negative is defined as: histologically confirmed to be HER2 IHC (0) or HER2 IHC(1+) or HER2 IHC (2+) and FISH(-);
  • MRI confirmed brain metastases, at least one intracranial parenchymal metastatic lesion with a longest diameter ≥ 1.0 cm without prior radiotherapy; For lesions with prior radiotherapy, progressive disease post radiotherapy must be confirmed by MRI
  • Any conditions deemed by the investigator to make the patient unnecessary for local therapy;
  • Life-expectancy ≥ 3 months;
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  • Intraventricular catheter shunt to reduce intracranial pressure or treatment with mannitol, hormones, and anticonvulsants was permitted prior to the first dose, but the dose of medication was stable for at least one week without increment and neurological symptoms were stable for ≥1 week;
  • Adequate function of major organs meets the following requirements:
  • (1)Blood routine: ANC≥1.5×109/L; PLT≥75×109/L; Hb ≥90 g/L(Allows blood transfusion or the use of medication to ensure that the content of hemoglobin) ; (2)Coagulation: INR≤1.5; APTT≤1.5×ULN ; (3)Blood biochemistry：TBIL≤1.5 × ULN; ALT and AST≤3 × ULN (liver metastasis≤5.0 × ULN); Urea nitrogen ≤1.5 × ULN; Cr≤1.5 × ULN or creatinine clearance ≥50 mL / min (Cockcroft-Gault formula) ; (4)Cardiac ultrasound: LVEF≥50%; (5)12-lead ECG: females QTcF interval < 470 ms and males < 450 ms; 9. Willing to join the study, sign informed consent, have good compliance and can cooperate with follow-up.

Who cannot join

  • Pial metastases confirmed by MRI or lumbar puncture;
  • Presence of third interstitial fluid that cannot be controlled by drainage or other methods (e.g., a large amount of pleural effusion and ascites);
  • Whole brain radiotherapy, chemotherapy, biological targeted therapy, immunotherapy, surgery or endocrine therapy within 2 weeks prior to enrolment;
  • Prior use of bevacizumab or other anti-angiogenic agents is prohibited, except for the following scenarios:a)No disease progression occurred during bevacizumab treatment, no confirmed drug resistance was identified, and the investigator deems continued use beneficial for the participant;b)Short-course bevacizumab was administered solely for the management of cerebral edema
  • Has received prior therapy with topoisomerase I inhibitors and ADC drugs regardless of targeting any target;
  • Participation in any other clinical trials 2 weeks before enrollment;
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  • Strong inhibitors or inducers of CYP3A4 are not permitted during the study, which includes the 4-week period prior to the first administration.
  • Concurrent use of any other Anti-cancer drugs;
  • Bleeding tendency such as acute gastrointestinal bleeding, persistent bleeding disease or coagulation dysfunction;
  • Other malignancies within 5 years, except cured in-situ of uterine cervix carcinoma , skin basal cell carcinoma and squamous-cell carcinoma;
  • History of (non-infectious) interstitial lung disease (ILD) or non-infectious pneumonia requiring steroid treatment, a current ILD or non-infectious pneumonia, or a suspected ILD or non-infectious pneumonia that could not be ruled out by imaging at the time of screening; Clinically severe lung impairment due to co-occurring lung disease, including but not limited to any underlying lung disease (pulmonary embolism, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion, etc.) or any autoimmune, connective tissue, or inflammatory disease that may involve the lungs , or prior total pulmonary resection;
  • History of severe dry eye syndrome, severe meibomian gland disease and/or blepharitis, or corneal disease that interferes with delayed corneal healing;
  • Severe infection within 4 weeks prior to initial dosing, including but not limited to complications requiring hospitalization, sepsis, or severe pneumonia; Active infections requiring systemic anti-infective therapy were present within 2 weeks prior to initial administration;
  • History of heart disease:
  • Arrhythmias requiring medical treatment or of clinical significance;
  • Myocardial infarction;
  • Heart failure;
  • Any heart diseases that investigator believes not suitable for this study;
  • History of allergy or hypersensitivity to any of the study drugs or study drug components;
  • History of immunodeficiency including HIV-positive, active hepatitis B/C, other acquired, congenital immunodeficiency disease or history of organ transplantation;
  • A clear history of neurological or mental disorders, including epilepsy or dementia;
  • According to the investigators' judgment, there is a concomitant disease that seriously endangers the safety of subjects or affects the completion of the study (including but not limited to severe hypertension, severe diabetes, active infection, thyroid disease that cannot be controlled by drugs);
  • Pregnant or breastfeeding women. Women of childbearing potential who have a positive pregnancy test or unwilling to use adequate contraception prior to enrollment and for the duration of study participation;
  • Any condition which in the investigators' opinion makes the subjects unsuitable for the study participation.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Biyun Wang contact

18017312387

pro_wangbiyun@163.com

China1 site, 1 recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200000

    BIYUN WANG professor, 8621 6417 5590

    Recruiting

Other trials in China

About this study

Official title: An Open-label, Single-arm, Multi-center Phase II Study of Sacituzumab Tirumotecan (Sac-TMT) Combined With Bevacizumab in Triple-negative Breast Cancer Patients With Brain Metastases

This is a single-arm, multi-center phase II study to evaluate the safety and efficacy Sacituzumab Tirumotecan (Sac-TMT) plus bevacizumab in triple-negative breast cancer patients with brain metastases. Twenty-four participants are planned to be enrolled. The eligible patients should have histologically or cytologically confirmed TNBC with BM.

Being tested
Sacituzumab Tirumotecan (Sac-TMT), bevacizumab
Keywords
trop2, Bevacizumab, Sacituzumab Tirumotecan, TNBC, brain metastasis
Medical subject headings
Brain Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sacituzumab Tirumotecan (Sac-TMT)Drug

    Eligible patients will receive a dosage of sac-TMT 4mg/kg Q2W

  • bevacizumabDrug

    safety run-in phase: bevacizumab 10mg/kg D1 Q2W

    Dose expansion phase: bevacizumab RP2D D1 Q2W

Study groups in NCT07623577
Study groupRoleWhat they receive
Sacituzumab Tirumotecan (Sac-TMT) plus BevacizumabExperimentalNot described
Receives: Drug: Sacituzumab Tirumotecan (Sac-TMT); Drug: bevacizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. CNS ORR

    The proportion of patients who have a CR or PR in the CNS, as determined by the Investigator according to RANO-BM criteria

    Measured: from enrollment to progression or death (for any reason), assessed up to 24 months

Secondary outcomes (5)

  1. CNS CBR

    CNS clinical benefit rate (CBR) will be defined as the percentage of patients who experience a CR, PR or Stable Disease (SD) for at least 24 weeks.

    Measured: from enrollment to progression or death (for any reason), assessed up to 24 months

  2. Progression-free survival

    PFS will be defined as the time from the first dose of treatment to death or disease progression

    Measured: Up to 2 years

  3. Overall survival

    OS will be defined as the time from the first dose of treatment to death for any cause

    Measured: Up to 2 years

  4. First progression site

    The first lesion to progress

    Measured: Up to 2 years

  5. Safety as assessed by percentage of patients with any Adverse Event

    Adverse event according to NCI-CTC AE 5.0

    Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jun 2026
  2. Study start1 Jan 2026
  3. Primary completionJan 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
This is a single-arm, multi-center phase II study to evaluate the safety and efficacy Sacituzumab Tirumotecan (Sac-TMT) plus bevacizumab in triple-negative breast cancer patients with brain metastases. Twenty-four participants are planned to be enrolled. The eligible patients should have histologically or cytologically confirmed TNBC with BM. This study includes a safety run-in period followed by an expansion cohort. The safety run-in period will employ the mTPI-2 (modified toxicity probability interval-2) design for an initial safety assessment. In Dose Expansion stage, 24 eligible patients will receive a dosage of sac-TMT 4mg/kg Q2W and the recommended dosage of bevacizumab in safety run-in period. Treatment will continue until disease progression or unacceptable toxicity. The primary endpoint is CNS ORR and secondary endpoints include CNS CBR, systemic ORR, PFS, OS, safety and tolerability.
Masking
None (open label)
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07623577
Sponsor's protocol ID
BCBM-007
Status last verified
Dec 2025
First submitted
18 Dec 2025
Last updated
3 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sacituzumab Tirumotecan (Sac-TMT) and bevacizumab in people with TNBC and Brain Metastasis, run by Fudan University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Biyun Wang (18017312387, pro_wangbiyun@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

CNS ORR (time frame: from enrollment to progression or death (for any reason), assessed up to 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07623577.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.

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