Triple-negative Breast CancerPhase 2NCT07876557
A Clinical Study to Evaluate the Efficacy and Safety of JS212 Monotherapy or Combination Therapy in Recurrent or Metastatic Triple-negative Breast Cancer(TNBC)
A Phase 2 study testing JS212 in combination with JS207, JS212 monotherapy and JS212 in combination with JS001 in people with Triple-negative Breast Cancer, run by Shanghai Junshi Bioscience Co., Ltd. at 31 sites in China.
Trial summary
This is an phase II study to prelininarily evaluate the efficacy and safety of JS212 mono therapy or combination therapy in patients with recurrent or metastatic TNBC. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Triple-negative Breast Cancer
- What is being tested?
- JS212 in combination with JS207, JS212 monotherapy and JS212 in combination with JS001
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 31 sitesChina
- Study dates
- 22 Oct 2026to 5 Mar 2029
- 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
- Male or female age 18-70 years old;
- Voluntary participation in clinical study;
- Histologically confirmed unresectable, locally advanced or metastatic triple-negative breast cancer(absence of HER2, ER, and PR expression);
- No prior systemic antitumor therapy for locally advanced or Metastatic TNBC（cohort expansion period); only one line of prior systemetic treatment for locally advanced or metastatic TNBC;
- Adequate organ function;
- ECOG performance status of 0 or 1;
- Life expectancy 12 weeks;
- Measurable disease, as defined by RECIST v1.1;
Who cannot join
- Untreated or active central nervous system (CNS) metastases;
- Uncontrolled pleural effusion, pericardial effusion or ascites;
- Tumor encasement of important vessels or significant necrosis and cavitation that may cause a risk of hemorrhage;
- History of significant bleeding tendency or severe coagulation disorder;
- Uncontrolled hypertension;
- Active autoimmune diseases requiring systemic treatmen within 2 years prior to the first dose;
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- History of interstitial lung disease or previous Noninfectious pneumonitis treated with corticosteroids, or evidence of active Pneumonia in radiology on screening period;
- History of immunodeficiency. Presence of active tuberculosis, hepatitis B, or hepatitis C;
- Severe cardiovascular disease;
- Serious infection (CTCAE 6.0 Grade>2) within 28 days prior to the first dose of study drug;
- Previous treatment of any anti-VRGF drugs targeting VEGF (part 1) or ADC drugs targeting EGFR and/or HER3;
- History of another malignancy within 5 years before the first dose of study drug;
- Not suitable to receive study treatment for other conditions as per investigator;
Trial locations and contacts
31 sites in 1 country. Contact the study team or a site near you to ask about taking part.
31 sites in 1 country
China31 sites, 31 recruiting
- Not yet recruiting
Affiliated Hospital of Hebei University
Baoding, Hebei, 071000
Hua Yang, Ph.D., 18603120729, docyh@163.com
Hua Yang, Ph.D.
- Not yet recruiting
The Fifth Medical Center of Chinese PLA General Hospital
Beijing, Beijing Municipality, 100071
Shaohua Zhang, Doctor, 13311591557, zhangsh19760428@163.com
Shaohua Zhang, Doctor
- Not yet recruiting
Peking University Shougang Hospital
Beijing, Beijing Municipality, 100144
Xueli Mo, Master, 13699180225, xuelimo@hotmail.com
Xueli Mo, Master
- Recruiting
Peking University People's Hospital
Beijing
Shu Wang, PhD., 13801080201, dr.wangshu@263.net
Shu Wang, Ph.D.
- Not yet recruiting
Jilin Provincial Cancer Hospital
Changchun, Jilin, 130012
Fei Chen, Master, 18604430968, Email:flyrcf@163.com
Fei Chen, Master
- Not yet recruiting
The First Hospital of Jilin University
Changchun, Jilin, 130021
Lihua Kang, Ph.D., 13504334518, kanglihua961002@163.com
Lihua Kang, Ph.D.
- Not yet recruiting
The First People's Hospital of Changde City
Changde, Hunan, 415003
Hui Li, Ph.D., 15886648808, 373099626@qq.com
Hui Li, Ph.D.
- Not yet recruiting
Hunan Cancer Hospital
Changsha, Hunan, 410013
Quchang Ouyang, Ph.D., 13973135318, oyqc1969@126.com
Quchang Ouyang, Ph.D.
- Not yet recruiting
Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072
Jing Luo, Ph.D., 18981838521, jingluopi@163.com
Jing Luo, Ph.D.
- Not yet recruiting
Fujian Cancer Hospital
Fuzhou, Fujian, 350000
Fan Wu, Ph.D., 13859082118, wufan_fj@163.com
Fan Wu, Ph.D.
- Not yet recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Shusen Wang, Ph.D., 13926168469, wangshs2019@163.com
Shusen Wang, Ph.D.
- Not yet recruiting
Guangdong General Hospital
Guangzhou, Guangdong, 510080
Kun Wang, Ph.D., 13922118086, bzwangkun@163.com
Kun Wang, Ph.D.
- Not yet recruiting
The Affiliated Cancer Hospital of Guizhou Medical University City: Guiyang
Guiyang, Guizhou, 550001
Zhihong Wang, Bachelor, 13595159308, Wzh1968626@sina.com
Zhihong Wang, Bachelor
- Not yet recruiting
The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, 550004
Shu Liu, Ph.D., 13908516963, drliushu@163.com
Shu Liu, Ph.D.
- Not yet recruiting
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081
Wenhui Zhao, Ph.D., 18745177632, zhaowenhui1977@163.com
Wenhui Zhao, Ph.D.
- Not yet recruiting
Cancer Hospital of Shandong First Medical University(Shandong Cancer Institute, Shandong Cancer Hospital)
Jinan, Shandong, 250117
Huihui Li, Ph.D., 15553103209, 15553103209@163.com
Qi Dang, Master, 15318816098, dangqi123456@126.com
- Not yet recruiting
Affiliated Hospital of Jining Medical University
Jining, Shandong, 272000
Changping Shan, Master, 18678766865, scp9933@163.com
Changping Shan, Master
- Not yet recruiting
The First Hospital of Lanzhou University
Lanzhou, Gansu, 730000
Xiaoling Ling, Ph.D., 18693165668, lingxiaolingedu@163.com
Xiaoling Ling, Ph.D.
- Not yet recruiting
Mianyang Central Hospital
Mianyang, Sichuan
Zhen zhang, Master, 13778159530, jiangzhangtong@sina.com
Zhen Zhang, Master
- Not yet recruiting
Nanchang People's Hospital
Nanchang, Jiangxi, 330009
Wenyan Chen, Bachelor, 18679168977, chenwenyannc2013@163.com
Wenyan Chen, Bachelor
- Not yet recruiting
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029
Wei Li, Ph.D., 13851603656, real.lw@163.com
Wei Li, Ph.D.
- Not yet recruiting
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266000
Haibo Wang, Ph.D., 18661805787, hbwangqy@126.com
Haibo Wang, Ph.D.
- Not yet recruiting
Shengjing Hospital of China Medical University
Shenyang, Liaoning, 110022
Xihe Zhao, Ph.D., 18940259508, zhaoxh@sj-hospital.org
Xihe Zhao, Ph.D.
- Not yet recruiting
Cancer Hospital of Dalian University of Technology(Liaoning Cancer Hospital & Institute)
Shenyang, Liaoning, 110042
Tao Sun, Ph.D., 13940404526, lnzlrxnsy@163.com
Tao Sun, Ph.D.
- Not yet recruiting
Introduction to the First Affiliated Hospital of China Medical University
Shenyang, Liaoning, 110167
Yuee Teng, Ph.D., 13591639797, tengyuee517@yahoo.com.cn
Yuee Teng, Ph.D.
- Not yet recruiting
Shanxi Cancer Hospital
Taiyuan, Shanxi, 030013
Guohui Han, Ph.D., 13754858188, 13754858188@163.com
Guohui Han, Ph.D.
- Not yet recruiting
Weifang People's Hospital
Weifang, Shandong, 261000
Wenhui Wang, Ph.D., 18605368857, wwh8857@163.com
Wenhui Wang, Ph.D.
- Not yet recruiting
Hubei Cancer Hospital
Wuhan, Hubei, 430079
Xinhong Wu, Ph.D., 18602726300, Xinhongwuhbch@163.com
Xinhong Wu, Ph.D.
- Not yet recruiting
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, 750000
Ye Lv, Bachelor, 18709515757, liuweilvye@yeah.net
Ye Lv, Bachelor
- Not yet recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450001
Hong Zong, Ph.D., 13623586882, zonghong522@126.com
Hong Zong, Ph.D.
- Not yet recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450002
Min Yan, Ph.D., 15713857388, ym200678@126.com
Min Yan, Ph.D.
About this study
Official title: A Phase II Study of JS212 Monotherapy or Combination Therapy With JS207 or JS001 in Recurrent or Metastatic Triple-negative Breast Cancer(TNBC)
This is an phase II study to prelininarily evaluate the efficacy and safety of JS212 mono therapy or combination therapy in patients with recurrent or metastatic TNBC.
Read the detailed description
The study consists of 2 parts. Both parts consist of safety run-in period and cohort expansion period. Safety run-in period will enroll those who have received only 1 line of prior systemic standard treatment. Cohort expansion period will enroll those are treated naive or recived treatment in adjuvant phase.
Part 1 will receive JS212 monotherapy or combination therapy with JS207, based on the PD-L1 expression. Part 2 will receive JS212 in combination with JS001.
- Conditions
- Triple-negative Breast Cancer
- Being tested
- JS212 in combination with JS207, JS212 monotherapy, JS212 in combination with JS001
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JS212 in combination with JS207Drug
JS212 and JS207 will be administered intravenously on D1, Q3W
JS212 monotherapyDrug
JS212 will be administered intravenously on D1，Q3W
JS212 in combination with JS001Drug
JS212 and JS001 will be administered intravenously on D1, Q3W
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Experimental | JS212 in combination with JS207，CPS≥10 Receives: Drug: JS212 in combination with JS207 |
| Cohort B | Experimental | JS212 monotherapy, CPS<10 Receives: Drug: JS212 monotherapy |
| Cohort C | Experimental | JS212 in combination with JS207, CPS<10 Receives: Drug: JS212 in combination with JS207 |
| Cohort D | Experimental | JS212 in combination with JS001 Receives: Drug: JS212 in combination with JS001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate（ORR）
Objective response rate（ORR） evaluated based on RECIST v1.1
Measured: 24 months
Secondary outcomes (9)
Duration of response (DoR)
Duration of response (DoR) evaluated based on RECIST v1.1
Measured: 24 months
Disease control rate (DOR)
Disease control rate (DOR)evaluated based on RECIST v1.1
Measured: 24 months
Progression free survival (PFS)
Progression free survival (PFS) evaluated based on RECIST v1.1
Measured: 24 months
Overall Survival (OS)
Overall Survival (OS)evaluated based on RECIST v1.1
Measured: 36 months
Adverse Events
Incidence and severity of Adverse Events(AEs)according to NCI-CTCAE v6.0
Measured: 24 months
Immunogenicity
The incidence of Nab(if applicable) of JS212 and JS207
Measured: 24 months
Plasma concentrations
Plasma concentrations of JS207 and 9MW2821
Measured: 2 years
PD-L1 expression
The correlation between PD-L1 expression in tumor tissue and therapeutic efficacy
Measured: 2 years
EGFR/HER expression
The correlation between EGFR/HER3 expression in tumor tissue and therapeutic efficacy
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study start22 Oct 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion5 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Triple-negative Breast CancerStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 184 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Junshi Bioscience Co., Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07876557
- Sponsor's protocol ID
- JS212-009-II-BC
- Status last verified
- Nov 2026
- First submitted
- 9 Oct 2026
- Last updated
- 5 Nov 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 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of JS212 Monotherapy or Combination Therapy With JS207 or JS001 in Recurrent or Metastatic Triple-negative Breast Cancer(TNBC)
- ClinicalTrials.gov ID
- NCT07876557
- Acronym / sponsor ID
- JS212-009-II-BC
- Conditions
- Triple-negative Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 184 participants (estimated)
- Lead sponsor
- Shanghai Junshi Bioscience Co., Ltd.University, hospital or other
- Study start
- 22 Oct 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 5 Mar 2029 (estimated)
- First posted
- 15 Oct 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 an phase II study to prelininarily evaluate the efficacy and safety of JS212 mono therapy or combination therapy in patients with recurrent or metastatic TNBC.
Detailed description
The study consists of 2 parts. Both parts consist of safety run-in period and cohort expansion period. Safety run-in period will enroll those who have received only 1 line of prior systemic standard treatment. Cohort expansion period will enroll those are treated naive or recived treatment in adjuvant phase.
Part 1 will receive JS212 monotherapy or combination therapy with JS207, based on the PD-L1 expression. Part 2 will receive JS212 in combination with JS001.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort A | Experimental | Drug: JS212 in combination with JS207JS212 in combination with JS207，CPS≥10 |
| Cohort B | Experimental | Drug: JS212 monotherapyJS212 monotherapy, CPS<10 |
| Cohort C | Experimental | Drug: JS212 in combination with JS207JS212 in combination with JS207, CPS<10 |
| Cohort D | Experimental | Drug: JS212 in combination with JS001JS212 in combination with JS001 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female age 18-70 years old;
- Voluntary participation in clinical study;
- Histologically confirmed unresectable, locally advanced or metastatic triple-negative breast cancer(absence of HER2, ER, and PR expression);
- No prior systemic antitumor therapy for locally advanced or Metastatic TNBC（cohort expansion period); only one line of prior systemetic treatment for locally advanced or metastatic TNBC;
- Adequate organ function;
Key exclusion criteria (13 listed)
- Untreated or active central nervous system (CNS) metastases;
- Uncontrolled pleural effusion, pericardial effusion or ascites;
- Tumor encasement of important vessels or significant necrosis and cavitation that may cause a risk of hemorrhage;
- History of significant bleeding tendency or severe coagulation disorder;
- Uncontrolled hypertension;
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 |
|---|---|---|
| JS212 in combination with JS207JS212 and JS207 will be administered intravenously on D1, Q3W | Drug | Cohort A, Cohort C |
| JS212 monotherapyJS212 will be administered intravenously on D1，Q3W | Drug | Cohort B |
| JS212 in combination with JS001JS212 and JS001 will be administered intravenously on D1, Q3W | Drug | Cohort D |
Primary outcome
Objective response rate（ORR）
Time frame: 24 months
Objective response rate（ORR） evaluated based on RECIST v1.1
9 secondary outcomes
Duration of response (DoR)
Time frame: 24 months
Disease control rate (DOR)
Time frame: 24 months
Progression free survival (PFS)
Time frame: 24 months
Overall Survival (OS)
Time frame: 36 months
Adverse Events
Time frame: 24 months
Immunogenicity
Time frame: 24 months
Plasma concentrations
Time frame: 2 years
PD-L1 expression
Time frame: 2 years
EGFR/HER expression
Time frame: 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 5 Nov 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.
31 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing JS212 in combination with JS207, JS212 monotherapy and JS212 in combination with JS001 in people with Triple-negative Breast Cancer, run by Shanghai Junshi Bioscience Co., Ltd. at 31 sites 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 8 inclusion and 13 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 5 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 31 sites 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 Chaoqiang Yang, PM (18252095266, chaoqiang_yang@junshipharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate（ORR） (time frame: 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 5 Nov 2026.