Triple-negative Breast CancerPhase 2NCT07045311

JS207 Combination Therapy in Triple-negative Breast Cancer

A Phase 2 study testing JS207 in combination with 9MW2821 and JS207 in combination with Albumin paclitaxel in people with Triple-negative Breast Cancer, run by Shanghai Junshi Bioscience Co., Ltd. at 22 sites 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

Search all trials

Trial summary

This is an open-label, multi-center, phase II clinical study to preliminarily evaluate the efficacy and safety of JS207 combined with 9MW2821 or albumin paclitaxel as first-line therapy in patients with recurrent or metastatic TNBC. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Triple-negative Breast Cancer
What is being tested?: JS207 in combination with 9MW2821 and JS207 in combination with Albumin paclitaxel
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 80 participants
Where: 22 sitesChina
Study dates: 17 Sep 2025to 22 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 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female age 18 - 75 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；
Prior use of systemic anti-tumor therapy in the neoadjuvant and/or adjuvant phase is allowed, but must meet the following conditions: (1) the time interval between the end of neoadjuvant/adjuvant therapy and the occurrence of recurrence/metastasis is ≥6 months; (2) Arm2: if taxane is used in the neoadjuvant/adjuvant phase, the DFI must be ≥12 months;
Adequate organ function;

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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；
Eye disorders or symptoms: severe xerophthalmia, keratoconjunctivitis sicca, severe exposure keratitis, or other conditions；
Severe cardiovascular disease；
Serious infection (CTCAE 5.0 Grade>2) within 28 days prior to the first dose of study drug；
Previous treatment with anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or drugs targeting other stimulatory or co-inhibitory T cell receptors (e.g., CTLA-4, OX-40, CD137) in (new) adjuvant therapy is allowed, if DFI is ≥6 months previously treated with Antibody-Drug Conjugates conjugated with MMAE and/or targeting Nectin-4, such as Enfortumab Vedotin is not allowed；
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

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

Chaoqiang Yang, Master contact

18252095266

chaoqiang_yang@junshipharma.com

City, postcode or hospital

Sites recruiting now only

22 sites in 1 country

China22 sites, 22 recruiting

Affiliated Hospital of Hebei University
Baoding, Hebei, 071030
Hua Yang, Doctor, 18603120729, docgh@163.com
Hua Yang
Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Shu Wang, Doctor
Shu Wang, Doctor
Recruiting
The Fifth Medical Center of PLA General Hospital
Beijing, Beijing Municipality, 100071
Zefei Jiang, Doctor, 13901372170, jzf_cscobc@csco.org.cn
Zefei Jiang, Doctor
Recruiting
Jilin University First Hospital
Changchun, Jilin, 130021
Zheng Lv, Doctor, 15804301705, 2886154@qq.com
Zheng Lv, Doctor
Recruiting
The Second Hospital of Dalian Medical University
Dalian, Liaoning, 116027
Man Li, Doctor, 17709873580, dyeyliman@sohu.com
Man Li, Doctor
Recruiting
Guangdong women and children's hospital and health institute
Guangzhou, Guangdong, 511400
Anqin Zhang, Doctor, 13925115929, 30542933@qq.com
Anqin Zhang, Doctor
Not yet recruiting
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000
Yiding Chen, Doctor, 13605719519, ydchen@zju.edu.cn
Yiding Chen, Doctor
Not yet recruiting
Harbin Medical University Affiliated Cancer Hospital
Harbin, Heilongjiang, 150001
Tong Liu, Doctor, 15945953777, liutong@hrbmu.edu.cn
Tong Liu, Doctor
Not yet recruiting
Harbin Medical University Affiliated Cancer Hospital
Harbin, Heilongjiang, 150001
Li Cai, Doctor, 13313602929, caiwenxin76@163.com
Li Cai, Doctor
Not yet recruiting
Anhui Provincial Cancer Hospital
Hefei, Anhui, 230000
Yueyin Pan, Doctor, 13805695536, yueyinpan1965@126.com
Yueyin Pan, Doctor
Not yet recruiting
Nanchang People'S Hospital
Nanchang, Jiangxi, 330000
Wenyan Chen, Doctor, 18679168977, chenwenyannc2013@163.com
Wenyan Chen, Doctor
Not yet recruiting
Jiangsu Cancer Hospital
Nanjing, Jiangsu, 210009
Sainan Hu, Doctor, 13770770678, hsndot@sina.com
Sainan Hu, Doctor
Recruiting
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029
Yongmei Yin, Doctor, 13951842727, ym.yin@hotmail.com
Yongmei Yin, Doctor
Not yet recruiting
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266035
Haibo Wang, Doctor, 18661805787, hbwang66@126.com
Haibo Wang, Doctor
Recruiting
The First Hospital of China Medical University
Shenyang, Liaoning, 110002
Yuee Teng, Doctor, 13591639797, tengyuee0517@163.com
Yuee Teng, Doctor
Recruiting
Liaoning Cancer Hospital&Institute
Shenyang, Liaoning, 110801
Tao Sun, Doctor, 13940404526, jianong@126.com
Tao Sun, Doctor
Recruiting
Affiliated Tumor Hospital of Xinjiang Medical University
Ürümqi, Xinjiang Uygur Autonomous Region, 830000
Bing Zhao, Doctor, 13899908184, 819502412@qq.com
Bing Zhao, Doctor
Recruiting
Hubei Cancer Hospital
Wuhan, Hubei, 430079
Xinhong Wu, Doctor, 18602726300, xinhongwuhbch@163.com
Xinhong Wu, Doctor
Recruiting
The First Affiliated Hospital of Xi'an Jiaotong University
Xian, Shanxi, 710061
Jin Yang, Doctor, 18991232383, 1473106133@qq.com
Jin Yang, Doctor
Recruiting
Xi'an International Medical Center Hospital
Xian, Shanxi, 710100
Yan Xue, Doctor, 13992830596, xueyan000516@163.com
Yan Xue, Doctor
Recruiting
Ceneral Hosipital of Ningxia Medical University
Yinchuan, Ningxia, 750000
Ye LV, Master, 18709515757, liuweilvye@yeah.net
Ye LV, Master
Not yet recruiting
Henan Cancer Hospital
Zhangzhou, Henan, 450003
Min Yan, Doctor, 15713857388, ym200678@126.com
Min Yan, Doctor
Recruiting

Other trials in China

About this study

Official title: JS207 Combination Therapy in Recurrent or Metastatic Triple-negative Breast Cancer(TNBC)

Read the detailed description

The study consists of Cohort A and Cohort B. Both cohorts include patients with recurrent or metastatic TNBC who have not received systemic anti-tumor therapy previously. Cohort A will receive JS207 combined with 9MW2821, and Cohort B will receive JS207 combined with albumin paclitaxel. Each cohort consists of two stages: safety run-in period and cohort expansion period.

Conditions: Triple-negative Breast Cancer
Being tested: JS207 in combination with 9MW2821, JS207 in combination with Albumin paclitaxel
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.

JS207 in combination with 9MW2821Drug
JS207 will be administered intravenously at a dose of 10 mg/kg (D1, Q3W), 9MW2821 will be administered intravenously at a dose of 1.25 m.g/kg (D1 and D8, Q3W)
JS207 in combination with Albumin paclitaxelDrug
JS207 will be administered intravenously at a dose of 10 mg/kg (D1, Q3W), Albumin paclitaxel will be administered intravenously at a dose of 125 mg/m2 (D1 and D8, Q3W).

Study groups in NCT07045311
Study group	Role	What they receive
Cohort A	Experimental	Not described Receives: Drug: JS207 in combination with 9MW2821
Cohort B	Experimental	Not described Receives: Drug: JS207 in combination with Albumin paclitaxel

What is being measured

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

ORR
Objective response rate（ORR） evaluated based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria
Measured: 2years

Secondary outcomes (9)

DOR
Duration of response (DoR) evaluated based on RECIST v1.1
Measured: 2years
DCR
Disease control rate (DCR) evaluated based on RECIST v1.1
Measured: 2years
PFS
Progression-free survival (PFS) evaluated based on RECIST v1.1
Measured: 2years
OS
The time from first dose to death from any cause
Measured: 3years
AE
Incidence and severity of Adverse Events(AEs)according to NCI-CTCAE v5.0
Measured: 2years
Plasma concentrations
Plasma concentrations of JS207 and 9MW2821.
Measured: 2years
ADA
The incidence and titer of anti-drug antibodies (ADA) of JS207 and 9MW2821
Measured: 2years
Nab
The incidence of Nab(if applicable) of JS207 and 9MW2821
Measured: 2years
PD-L1
The correlation between PD-L1 expression in tumor tissue and therapeutic efficacy
Measured: 2years

Timeline

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

17 Sep 202522 Mar 2029

First posted1 Jul 2025
Study start17 Sep 2025
Primary completion22 Mar 2028 (estimated)
Study completion22 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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 80 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07045311
Sponsor's protocol ID: JS207-008-II-TNBC
Status last verified: Apr 2026
First submitted: 23 Jun 2025
Last updated: 15 Apr 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 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: JS207 Combination Therapy in Recurrent or Metastatic Triple-negative Breast Cancer(TNBC)
ClinicalTrials.gov ID: NCT07045311
Acronym / sponsor ID: JS207-008-II-TNBC
Conditions: Triple-negative Breast Cancer
Phase: Phase 2
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 80 participants (estimated)
Lead sponsor: Shanghai Junshi Bioscience Co., Ltd.University, hospital or other
Study start: 17 Sep 2025 (actual)
Primary completion: 22 Mar 2028 (estimated)
Study completion: 22 Mar 2029 (estimated)
First posted: 1 Jul 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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Cohort A	Experimental	Drug: JS207 in combination with 9MW2821
Cohort B	Experimental	Drug: JS207 in combination with Albumin paclitaxel

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Male or female age 18 - 75 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；
Prior use of systemic anti-tumor therapy in the neoadjuvant and/or adjuvant phase is allowed, but must meet the following conditions: (1) the time interval between the end of neoadjuvant/adjuvant therapy and the occurrence of recurrence/metastasis is ≥6 months; (2) Arm2: if taxane is used in the neoadjuvant/adjuvant phase, the DFI must be ≥12 months;

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
JS207 in combination with 9MW2821JS207 will be administered intravenously at a dose of 10 mg/kg (D1, Q3W), 9MW2821 will be administered intravenously at a dose of 1.25 m.g/kg (D1 and D8, Q3W)	Drug	Cohort A
JS207 in combination with Albumin paclitaxelJS207 will be administered intravenously at a dose of 10 mg/kg (D1, Q3W), Albumin paclitaxel will be administered intravenously at a dose of 125 mg/m2 (D1 and D8, Q3W).	Drug	Cohort B

Primary outcome

ORR
Time frame: 2years
Objective response rate（ORR） evaluated based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria

9 secondary outcomes

DOR
Time frame: 2years
DCR
Time frame: 2years
PFS
Time frame: 2years
OS
Time frame: 3years
AE
Time frame: 2years
Plasma concentrations
Time frame: 2years
ADA
Time frame: 2years
Nab
Time frame: 2years
PD-L1
Time frame: 2years

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 15 Apr 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.

Chaoqiang Yang, Master contact

18252095266

chaoqiang_yang@junshipharma.com

22 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 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 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 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, Master (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?

ORR (time frame: 2years). 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 NCT07045311.

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 15 Apr 2026.