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.
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.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200000
BIYUN WANG professor, 8621 6417 5590
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.
- Conditions
- TNBC, Brain Metastasis
- 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 group | Role | What they receive |
|---|---|---|
| Sacituzumab Tirumotecan (Sac-TMT) plus Bevacizumab | Experimental | Not 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.
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)
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
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
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
First progression site
The first lesion to progress
Measured: Up to 2 years
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.
- First posted3 Jun 2026
- Study start1 Jan 2026
- Primary completionJan 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TNBCStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Biyun Wang, MD, Fudan University
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
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07623577
- Acronym / sponsor ID
- BCBM-007
- Conditions
- TNBC, Brain Metastasis
- Keywords
- trop2, Bevacizumab, Sacituzumab Tirumotecan, TNBC, brain metastasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 3 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Sacituzumab Tirumotecan (Sac-TMT) plus Bevacizumab | Experimental | Drug: Sacituzumab Tirumotecan (Sac-TMT), Drug: bevacizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (24 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sacituzumab Tirumotecan (Sac-TMT)Eligible patients will receive a dosage of sac-TMT 4mg/kg Q2W | Drug | Sacituzumab Tirumotecan (Sac-TMT) plus Bevacizumab |
| bevacizumabsafety run-in phase: bevacizumab 10mg/kg D1 Q2W Dose expansion phase: bevacizumab RP2D D1 Q2W | Drug | Sacituzumab Tirumotecan (Sac-TMT) plus Bevacizumab |
Primary outcome
CNS ORR
Time frame: from enrollment to progression or death (for any reason), assessed up to 24 months
The proportion of patients who have a CR or PR in the CNS, as determined by the Investigator according to RANO-BM criteria
5 secondary outcomes
CNS CBR
Time frame: from enrollment to progression or death (for any reason), assessed up to 24 months
Progression-free survival
Time frame: Up to 2 years
Overall survival
Time frame: Up to 2 years
First progression site
Time frame: Up to 2 years
Safety as assessed by percentage of patients with any Adverse Event
Time frame: Up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
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?
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.