Triple-Negative Breast Cancer (TNBC)Phase 2BALISTANCT06793332
BrAin Metastasis in tripLe Negateive Breast Cancer: IvoneScimab and Trop2 ADC
A Phase 2 study testing Ivonescimab Combined With TROP2 ADC in people with Triple-Negative Breast Cancer (TNBC) and Brain Metastases, run by Fudan University at 1 site in China.
Trial summary
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 or sacituzumab tirumotecan) treatment until disease progression, intolerable… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Triple-Negative Breast Cancer (TNBC), Brain Metastases
- What is being tested?
- Ivonescimab Combined With TROP2 ADC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteChina
- Study dates
- 5 Feb 2025to 31 May 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years and ≤ 70 years, with no gender restrictions;
- ECOG performance score of 0 to 2;
- Expected survival ≥ 3 months;
- Patients with unresectable locally advanced, recurrent or metastatic triple-negative breast cancer who have failed treatment with taxane drugs are included.
- 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.
- 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;
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- 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;
- 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;
- 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;
- All patients enrolled are required to have adequate hematologic, hepatic, and renal function;
- Be able to understand the study procedures and sign informed consent.
Who cannot join
- Patients with soft meningeal metastases confirmed by MRI or lumbar puncture;
- Presence of third-space effusion that cannot be controlled by drainage or other methods (such as large amounts of pleural effusion and ascites);
- 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;
- Previously used monoclonal or bispecific antibodies containing anti-VEGF-A and anti-PD-1/PD-L1/CTLA-4; previously used TROP2 ADC drugs.
- Participated in other drug clinical trials within 2 weeks before enrollment;
- Simultaneously receiving any anti-tumor treatment for other tumors;
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- 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;
- 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;
- Known hypersensitivity to the components of the investigational drug;
- 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.
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, China 200032
Yiqun Du, MD, PhD, +8618121299359, dyqlh2010@163.com
About this study
Official title: Prospective, One-arm, Phase II Clinical Study of Ivoximab Combined With TROP2 ADC in the Treatment of Brain Metastases in Triple-negative Breast Cancer
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 or sacituzumab tirumotecan) 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.
Read the detailed description
Brain metastasis is a common site of metastasis in triple-negative breast cancer (TNBC), with an incidence rate of approximately 30-45%. Once breast cancer patients develop brain metastasis, their survival period is short and prognosis is poor. The median overall survival (mOS) of TNBC patients with brain metastasis is even less than 6 months. Therefore, it is necessary and urgent to explore effective treatment regimens to improve the survival of patients with breast cancer brain metastasis.
In recent years, several novel drugs, including immunotherapy, anti-angiogenic targeted therapy, and antibody-drug conjugates (ADCs), have achieved significant success in metastatic TNBC, significantly improving the prognosis and survival of advanced TNBC. The combination of immune checkpoint inhibitors and anti-angiogenic therapy has also become an important treatment strategy for TNBC. The results of a phase Ib/II study of PM8002 (a bispecific antibody targeting PD-L1 and VEGF-A, exerting both immune and anti-angiogenic effects) combined with albumin-bound paclitaxel in the treatment of advanced TNBC patients showed that the objective response rate (ORR) was 78.6%, and the median progression-free survival (mPFS) was 14 months. AK112, a bispecific antibody targeting PD-1 and VEGF-A, combined with chemotherapy, was approved by the National Medical Products Administration（NMPA） of Cnina on May 10, 2024, for the treatment of patients with advanced non-squamous NSCLC with EGFR mutations who have progressed after EGFR-TKI treatment. Notably, the efficacy analysis of NSCLC patients with baseline brain metastasis in the 201/202 studies of AK112 showed that the intracranial response rate of AK112 combined with platinum-based chemotherapy was 39% (including 25% complete response); the intracranial response rate of AK112 monotherapy also reached 14%. For untreated brain metastasis patients, the intracranial mPFS of the AK112-containing regimen was as long as 19.3 months. At the 2024 ESMO conference, a study on the safety and efficacy of AK112 combined with paclitaxel or albumin-bound paclitaxel as first-line treatment for advanced TNBC was reported. The study results showed that the overall ORR was 78.8%, the 6-month PFS rate was 73.3%, and the mPFS and OS have not yet been reached. These results suggest that AK112 may also have great application potential in TNBC patients with brain metastasis. In addition, sacituzumab govitecan is a novel ADC targeting TROP2. Based on the results of the large-scale phase III ASCENT study, it has been approved for the treatment of second-line and later-line metastatic TNBC. Through subgroup analysis of brain metastasis patients in the ASCENT study, we found that the PFS of brain metastasis patients in the SG group was significantly better than that of the control chemotherapy group (2.8 months vs. 1.6 months), indicating that ADCs targeting the TROP2 also have good efficacy in TNBC brain metastasis. Therefore, a prospective, single-arm, phase II clinical study of AK112 combined with TROP2 ADC in the treatment of triple-negative breast cancer brain metastasis is planned, aiming to explore the efficacy and safety of AK112 combined with TROP2 ADC in the treatment of TNBC brain metastasis patients.
- Being tested
- Ivonescimab Combined With TROP2 ADC
- Keywords
- triple-negative breast cancer, brain metastases, Ivonescimab, TROP2 ADCs
- Medical subject headings
- Triple Negative Breast Neoplasms, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ivonescimab Combined With TROP2 ADCDrug
Also called AK112 Combined With TROP2 ADC
Therapeutic regimen 1：Ivonescimab 20 mg/kg, ivggt, day 1, every 3 weeks; Sacituzumab govitecan 10 mg/kg, ivggt, day 1 and day 8, every 3 weeks. Therapeutic regimen 2： Ivonescimab 20 mg/kg, ivggt, day 1, every 4 weeks; sacituzumab tirumotecan 5 mg/kg, ivggt, day 1 and day 14, every 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Ivonescimab combined with TROP2 ADC | Experimental | Not described Receives: Drug: Ivonescimab Combined With TROP2 ADC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intracranial objective response rate (CNS ORR)
CNS ORR is the percentage of participants with the best objective response of complete response (CR) or partial response (PR) of Intracranial metastatic lesions according to RANO-BM criteria. CR = Disappearance of all non-nodal target lesions. PR = At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
Measured: 22 months（Up to approximately 12 weeks after the last patient's enrollment）
Secondary outcomes (3)
Intracranial clinical benefit rate (CNS CBR)
Percentage of participants with complete response (CR) or partial response (PR) or stable disease (SD) lasting 4 weeks or longer of intracranial metastatic lesions as defined in RANO-BM criteria.
Measured: 22 months（Up to approximately 12 weeks after the last patient's enrollment）
Progression-Free Survival (PFS)
PFS defined as the time from the date of randomization to the first evidence of disease progression as defined by response evaluation criteria in solid tumors (RECIST) v1.1 or death from any cause. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. If a participant does not have a complete baseline disease assessment, then the PFS time was censored at the date of randomization, regardless of whether or not objectively determined disease progression or death has been observed for the participant. If a participant was not known to have died or have objective progression as of the data inclusion cutoff date for the analysis, the PFS time was censored at the last adequate tumor assessment date.
Measured: 30 months
Overall Survival (OS)
Time from date of randomization to the date of death from any cause
Measured: 40 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2025
- Study start5 Feb 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Triple-Negative Breast Cancer (TNBC)Studies 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
- Masking
- None (open label)
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian Zhang,MD, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06793332
- Sponsor's protocol ID
- BALISTA（YBCSG-24-01）
- Acronym
- BALISTA
- Status last verified
- Oct 2026
- First submitted
- 28 Dec 2024
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bardia A, Rugo HS, Tolaney SM, Loirat D, Punie K, Oliveira M, Brufsky A, Kalinsky K, Cortes J, Shaughnessy JO, Dieras V, Carey LA, Gianni L, Piccart-Gebhart M, Loibl S, Yoon OK, Pan Y, Hofsess S, Phan SC, Hurvitz SA. Final Results From the Randomized Phase III ASCENT Clinical Trial in Metastatic Triple-Negative Breast Cancer and Association of Outcomes by Human Epidermal Growth Factor Receptor 2 and Trophoblast Cell Surface Antigen 2 Expression. J Clin Oncol. 2024 May 20;42(15):1738-1744. doi: 10.1200/JCO.23.01409. Epub 2024 Feb 29.
PubMed 38422473Naito Y, Nakamura S, Kawaguchi-Sakita N, Ishida T, Nakayama T, Yamamoto Y, Masuda N, Matsumoto K, Kogawa T, Sudo K, Shimomura A, Lai C, Zhang D, Iwahori Y, Gary D, Huynh D, Iwata H. Preliminary results from ASCENT-J02: a phase 1/2 study of sacituzumab govitecan in Japanese patients with advanced solid tumors. Int J Clin Oncol. 2024 Nov;29(11):1684-1695. doi: 10.1007/s10147-024-02589-x. Epub 2024 Sep 20.
PubMed 39302614Frentzas S, Austria Mislang AR, Lemech C, Nagrial A, Underhill C, Wang W, Wang ZM, Li B, Xia Y, Coward JIG. Phase 1a dose escalation study of ivonescimab (AK112/SMT112), an anti-PD-1/VEGF-A bispecific antibody, in patients with advanced solid tumors. J Immunother Cancer. 2024 Apr 19;12(4):e008037. doi: 10.1136/jitc-2023-008037.
PubMed 38642937Zhao Y, Chen G, Chen J, Zhuang L, Du Y, Yu Q, Zhuang W, Zhao Y, Zhou M, Zhang W, Zhang Y, Wan Y, Li W, Song W, Wang ZM, Li B, Xia M, Yang Y, Fang W, Huang Y, Zhang L. AK112, a novel PD-1/VEGF bispecific antibody, in combination with chemotherapy in patients with advanced non-small cell lung cancer (NSCLC): an open-label, multicenter, phase II trial. EClinicalMedicine. 2023 Aug 3;62:102106. doi: 10.1016/j.eclinm.2023.102106. eCollection 2023 Aug.
PubMed 37593227
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, One-arm, Phase II Clinical Study of Ivoximab Combined With TROP2 ADC in the Treatment of Brain Metastases in Triple-negative Breast Cancer
- ClinicalTrials.gov ID
- NCT06793332
- Acronym / sponsor ID
- BALISTA / BALISTA（YBCSG-24-01）
- Keywords
- triple-negative breast cancer, brain metastases, Ivonescimab, TROP2 ADCs
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 5 Feb 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 27 Jan 2025 (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 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 or sacituzumab tirumotecan) 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.
Detailed description
Brain metastasis is a common site of metastasis in triple-negative breast cancer (TNBC), with an incidence rate of approximately 30-45%. Once breast cancer patients develop brain metastasis, their survival period is short and prognosis is poor. The median overall survival (mOS) of TNBC patients with brain metastasis is even less than 6 months. Therefore, it is necessary and urgent to explore effective treatment regimens to improve the survival of patients with breast cancer brain metastasis.
In recent years, several novel drugs, including immunotherapy, anti-angiogenic targeted therapy, and antibody-drug conjugates (ADCs), have achieved significant success in metastatic TNBC, significantly improving the prognosis and survival of advanced TNBC. The combination of immune checkpoint inhibitors and anti-angiogenic therapy has also become an important treatment strategy for TNBC. The results of a phase Ib/II study of PM8002 (a bispecific antibody targeting PD-L1 and VEGF-A, exerting both immune and anti-angiogenic effects) combined with albumin-bound paclitaxel in the treatment of advanced TNBC patients showed that the objective response rate (ORR) was 78.6%, and the median progression-free survival (mPFS) was 14 months. AK112, a bispecific antibody targeting PD-1 and VEGF-A, combined with chemotherapy, was approved by the National Medical Products Administration（NMPA） of Cnina on May 10, 2024, for the treatment of patients with advanced non-squamous NSCLC with EGFR mutations who have progressed after EGFR-TKI treatment. Notably, the efficacy analysis of NSCLC patients with baseline brain metastasis in the 201/202 studies of AK112 showed that the intracranial response rate of AK112 combined with platinum-based chemotherapy was 39% (including 25% complete response); the intracranial response rate of AK112 monotherapy also reached 14%. For untreated brain metastasis patients, the intracranial mPFS of the AK112-containing regimen was as long as 19.3 months. At the 2024 ESMO conference, a study on the safety and efficacy of AK112 combined with paclitaxel or albumin-bound paclitaxel as first-line treatment for advanced TNBC was reported. The study results showed that the overall ORR was 78.8%, the 6-month PFS rate was 73.3%, and the mPFS and OS have not yet been reached. These results suggest that AK112 may also have great application potential in TNBC patients with brain metastasis. In addition, sacituzumab govitecan is a novel ADC targeting TROP2. Based on the results of the large-scale phase III ASCENT study, it has been approved for the treatment of second-line and later-line metastatic TNBC. Through subgroup analysis of brain metastasis patients in the ASCENT study, we found that the PFS of brain metastasis patients in the SG group was significantly better than that of the control chemotherapy group (2.8 months vs. 1.6 months), indicating that ADCs targeting the TROP2 also have good efficacy in TNBC brain metastasis. Therefore, a prospective, single-arm, phase II clinical study of AK112 combined with TROP2 ADC in the treatment of triple-negative breast cancer brain metastasis is planned, aiming to explore the efficacy and safety of AK112 combined with TROP2 ADC in the treatment of TNBC brain metastasis patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ivonescimab combined with TROP2 ADC | Experimental | Drug: Ivonescimab Combined With TROP2 ADC |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age ≥ 18 years and ≤ 70 years, with no gender restrictions;
- ECOG performance score of 0 to 2;
- Expected survival ≥ 3 months;
- Patients with unresectable locally advanced, recurrent or metastatic triple-negative breast cancer who have failed treatment with taxane drugs are included.
- 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.
Key exclusion criteria (11 listed)
- Patients with soft meningeal metastases confirmed by MRI or lumbar puncture;
- Presence of third-space effusion that cannot be controlled by drainage or other methods (such as large amounts of pleural effusion and ascites);
- 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;
- Previously used monoclonal or bispecific antibodies containing anti-VEGF-A and anti-PD-1/PD-L1/CTLA-4; previously used TROP2 ADC drugs.
- Participated in other drug clinical trials within 2 weeks before enrollment;
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 |
|---|---|---|
| Ivonescimab Combined With TROP2 ADCAlso: AK112 Combined With TROP2 ADCTherapeutic regimen 1：Ivonescimab 20 mg/kg, ivggt, day 1, every 3 weeks; Sacituzumab govitecan 10 mg/kg, ivggt, day 1 and day 8, every 3 weeks. Therapeutic regimen 2： Ivonescimab 20 mg/kg, ivggt, day 1, every 4 weeks; sacituzumab tirumotecan 5 mg/kg, ivggt, day 1 and day 14, every 4 weeks. | Drug | Ivonescimab combined with TROP2 ADC |
Primary outcome
Intracranial objective response rate (CNS ORR)
Time frame: 22 months（Up to approximately 12 weeks after the last patient's enrollment）
CNS ORR is the percentage of participants with the best objective response of complete response (CR) or partial response (PR) of Intracranial metastatic lesions according to RANO-BM criteria. CR = Disappearance of all non-nodal target lesions. PR = At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
3 secondary outcomes
Intracranial clinical benefit rate (CNS CBR)
Time frame: 22 months（Up to approximately 12 weeks after the last patient's enrollment）
Progression-Free Survival (PFS)
Time frame: 30 months
Overall Survival (OS)
Time frame: 40 months
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 6 Nov 2026.
- Results publication: PubMed 38422473Bardia A, Rugo HS, Tolaney SM, Loirat D, Punie K, Oliveira M, Brufsky A, Kalinsky K, Cortes J, Shaughnessy JO, Dieras V, Carey LA, Gianni L, Piccart-Gebhart M, Loibl S, Yoon OK, Pan Y, Hofsess S, Phan SC, Hurvitz SA. Final Results From the Randomized Phase III ASCENT Clinical Trial in Metastatic Triple-Negative Breast Cancer and Association of Outcomes by Human Epidermal Growth Factor Receptor 2 and Trophoblast Cell Surface Antigen 2 Expression. J Clin Oncol. 2024 May 20;42(15):1738-1744. doi: 10.1200/JCO.23.01409. Epub 2024 Feb 29.
- Results publication: PubMed 39302614Naito Y, Nakamura S, Kawaguchi-Sakita N, Ishida T, Nakayama T, Yamamoto Y, Masuda N, Matsumoto K, Kogawa T, Sudo K, Shimomura A, Lai C, Zhang D, Iwahori Y, Gary D, Huynh D, Iwata H. Preliminary results from ASCENT-J02: a phase 1/2 study of sacituzumab govitecan in Japanese patients with advanced solid tumors. Int J Clin Oncol. 2024 Nov;29(11):1684-1695. doi: 10.1007/s10147-024-02589-x. Epub 2024 Sep 20.
- Results publication: PubMed 38642937Frentzas S, Austria Mislang AR, Lemech C, Nagrial A, Underhill C, Wang W, Wang ZM, Li B, Xia Y, Coward JIG. Phase 1a dose escalation study of ivonescimab (AK112/SMT112), an anti-PD-1/VEGF-A bispecific antibody, in patients with advanced solid tumors. J Immunother Cancer. 2024 Apr 19;12(4):e008037. doi: 10.1136/jitc-2023-008037.
- Results publication: PubMed 37593227Zhao Y, Chen G, Chen J, Zhuang L, Du Y, Yu Q, Zhuang W, Zhao Y, Zhou M, Zhang W, Zhang Y, Wan Y, Li W, Song W, Wang ZM, Li B, Xia M, Yang Y, Fang W, Huang Y, Zhang L. AK112, a novel PD-1/VEGF bispecific antibody, in combination with chemotherapy in patients with advanced non-small cell lung cancer (NSCLC): an open-label, multicenter, phase II trial. EClinicalMedicine. 2023 Aug 3;62:102106. doi: 10.1016/j.eclinm.2023.102106. eCollection 2023 Aug.
- 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 Ivonescimab Combined With TROP2 ADC in people with Triple-Negative Breast Cancer (TNBC) and Brain Metastases, 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 11 inclusion and 11 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 6 Nov 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 Jian Zhang, MD,PhD (+8618017312991, syner2000@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intracranial objective response rate (CNS ORR) (time frame: 22 months（Up to approximately 12 weeks after the last patient's enrollment）). 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 NCT06793332, which also lists 4 linked publications.
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 6 Nov 2026.