SHR-A1921 Combined With Bevacizumab in Triple-negative Breast Cancer With Brain Metastases

Study Purpose

This is a phaseⅡ, single-arm study evaluating the efficacy and safety of SHR-A1921 Combined with Bevacizumab in Triple-negative Breast Cancer with Brain Metastases

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Age ≥ 18 years old, both genders. 2. ECOG Performance Status of 0-2. 3. Pathological tests confirm HR-negative/HER2-negative breast cancer;there is evidence of local recurrence or 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(-) 4.
Must have life-expectancy of ≥ 3 months. 5. MRI confirmed brain metastases, at least one intracranial parenchymal metastatic lesion with a longest diameter ≥ 1.0 cm without prior radiotherapy; 6. Intraventricular catheter shunting or mannitol、steroid hormone、anticonvulsant drug is allowed before enrollment, but the dose of drug should be stable for at least one week and the neurological symptoms are stable for ≥1 week. 7. 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 <470msec and males <450ms; 8.
Willing to join the study, sign informed consent, have good compliance and cooperate with follow-up.

Exclusion Criteria:

1. Leptomeningeal or cystic metastases confirmed by MRI or lumbar puncture. 2. Presence of third interstitial fluid that cannot be controlled by drainage or other methods (e.g., a large amount of pleural effusion and ascites); 3. Whole brain radiotherapy, chemotherapy, biological targeted therapy, immunotherapy, surgery or endocrine therapy within 2 weeks prior to enrolment. 4. Has received prior therapy with bevacizumab and TROP-2 ADC drugs. 5. Participation in any other clinical trials within 2 weeks of enrollment. 6. Concurrent use of any other Anti-cancer drugs. 7. Other malignancies within 5 years, except cured in-situ of uterine cervix carcinoma , skin basal cell carcinoma and squamous-cell carcinoma. 8. History of heart disease:
  • (1) Arrhythmias requiring medical treatment or clinical significance, (2) Myocardial infarction, (3) Heart failure, (4)Any heart diseases that investigator believes not suitable for this study.
9. History of allergy or hypersensitivity to any of the study drugs or study drug components. 10. History of immunodeficiency including HIV-positive, active hepatitis B/C, other acquired, congenital immunodeficiency disease or history of organ transplantation. 11. A clear history of neurological or mental disorders, including epilepsy or dementia. 12. 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. 13. According to the investigator's 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) 14. Any condition which in the investigator's opinion makes the subjects unsuitable for the study participation

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06210438
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Fudan University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Biyun wang
Principal Investigator Affiliation Fudan University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Not yet recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

TNBC, Brain Metastasis
Arms & Interventions

Arms

Experimental: SHR-A1921 + Bevacizumab

Interventions

Drug: - SHR-A1921 + Bevacizumab

SHR-A1921 + Bevacizumab

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Fudan University Shanghai Cancer Center, Shanghai, Shanghai, China

Status

Address

Fudan University Shanghai Cancer Center

Shanghai, Shanghai, 200032

Site Contact

Biyun Wang

[email protected]

+86-021-64175590

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