JS207 with 9MW2821 or albumin-bound paclitaxel for recurrent or metastatic triple-negative breast cancer

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

This trial will try JS207 together with either 9MW2821 or albumin-bound paclitaxel as first-line treatment for people with recurrent or metastatic triple-negative breast cancer who have not had systemic therapy for their advanced disease.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Shanghai Junshi Bioscience Co., Ltd. (Academic / other)
• Drugs / interventions: Enfortumab
• Locations: 22 sites (Hefei, Anhui and 21 other locations)
• Trial ID: NCT07045311 on ClinicalTrials.gov

What this trial studies

This open-label, multicenter Phase II trial tests two combination regimens: JS207 plus 9MW2821 (Cohort A) and JS207 plus albumin-bound paclitaxel (Cohort B) in patients with unresectable locally advanced or metastatic triple-negative breast cancer. Each cohort begins with a safety run-in period to assess tolerability, followed by a cohort expansion period to collect preliminary efficacy and further safety data. Eligible patients must have measurable disease per RECIST v1.1, ECOG performance status 0–1, adequate organ function, and no prior systemic therapy for advanced TNBC, with certain allowances for prior (neo)adjuvant treatment after specified disease-free intervals. The trial is conducted at multiple centers in China and aims to characterize response rates and safety signals for these combinations.

Who should consider this trial

Good fit: Adults 18–75 with histologically confirmed unresectable locally advanced or metastatic triple-negative breast cancer, measurable disease, ECOG 0–1, adequate organ function, and no prior systemic therapy for advanced disease are the ideal candidates.

Not a fit: Patients with untreated or active CNS metastases, uncontrolled pleural/pericardial effusion or ascites, prior systemic therapy for metastatic TNBC, or poor organ function/ECOG >1 are unlikely to receive benefit from this protocol.

Why it matters

Potential benefit: If successful, this could offer a new first-line combination option that improves tumor response or delays progression in recurrent or metastatic TNBC.

How similar studies have performed: Combining novel targeted agents with taxanes has produced benefit in TNBC in other programs (for example antibody–drug conjugates), but JS207 combinations are early-stage and not yet proven.

Eligibility criteria

Inclusion Criteria:

1. Male or female age 18 - 75 years old；
2. Voluntary participation in clinical study；
3. Histologically confirmed unresectable, locally advanced or metastatic triple-negative breast cancer(absence of HER2, ER, and PR expression);
4. No prior systemic antitumor therapy for locally advanced or Metastatic TNBC；
5. 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;
6. Adequate organ function;
7. ECOG performance status of 0 or 1;
8. Life expectancy 12 weeks;
9. Measurable disease, as defined by RECIST v1.1;

Exclusion Criteria:

1. Untreated or active central nervous system (CNS) metastases；
2. Uncontrolled pleural effusion, pericardial effusion or ascites；
3. Tumor encasement of important vessels or significant necrosis and cavitation that may cause a risk of hemorrhage；
4. History of significant bleeding tendency or severe coagulation disorder；
5. Uncontrolled hypertension；
6. Active autoimmune diseases requiring systemic treatmen within 2 years prior to the first dose；
7. History of interstitial lung disease or previous Noninfectious pneumonitis treated with corticosteroids, or evidence of active Pneumonia in radiology on screening period；
8. Eye disorders or symptoms: severe xerophthalmia, keratoconjunctivitis sicca, severe exposure keratitis, or other conditions；
9. Severe cardiovascular disease；
10. Serious infection (CTCAE 5.0 Grade\>2) within 28 days prior to the first dose of study drug；
11. 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；
12. History of another malignancy within 5 years before the first dose of study drug；
13. Not suitable to receive study treatment for other conditions as per investigator；

Where this trial is running

Hefei, Anhui and 21 other locations

• Anhui Provincial Cancer Hospital — Hefei, Anhui, China (Not_yet_recruiting)
• Peking University People's Hospital — Beijing, Beijing Municipality, China (Recruiting)
• The Fifth Medical Center of PLA General Hospital — Beijing, Beijing Municipality, China (Recruiting)
• Guangdong women and children's hospital and health institute — Guangzhou, Guangdong, China (Not_yet_recruiting)
• Affiliated Hospital of Hebei University — Baoding, Hebei, China (Recruiting)
• Harbin Medical University Affiliated Cancer Hospital — Harbin, Heilongjiang, China (Not_yet_recruiting)
• Harbin Medical University Affiliated Cancer Hospital — Harbin, Heilongjiang, China (Not_yet_recruiting)
• Henan Cancer Hospital — Zhangzhou, Henan, China (Recruiting)
• Hubei Cancer Hospital — Wuhan, Hubei, China (Recruiting)
• Jiangsu Cancer Hospital — Nanjing, Jiangsu, China (Recruiting)
• Jiangsu Province Hospital — Nanjing, Jiangsu, China (Not_yet_recruiting)
• Nanchang People'S Hospital — Nanchang, Jiangxi, China (Not_yet_recruiting)
• Jilin University First Hospital — Changchun, Jilin, China (Recruiting)
• The Second Hospital of Dalian Medical University — Dalian, Liaoning, China (Recruiting)
• The First Hospital of China Medical University — Shenyang, Liaoning, China (Recruiting)
• Liaoning Cancer Hospital&Institute — Shenyang, Liaoning, China (Recruiting)
• Ceneral Hosipital of Ningxia Medical University — Yinchuan, Ningxia, China (Not_yet_recruiting)
• The Affiliated Hospital of Qingdao University — Qingdao, Shandong, China (Recruiting)
• The First Affiliated Hospital of Xi'an Jiaotong University — Xian, Shanxi, China (Recruiting)
• Xi'an International Medical Center Hospital — Xian, Shanxi, China (Recruiting)
• Affiliated Tumor Hospital of Xinjiang Medical University — Ürümqi, Xinjiang Uygur Autonomous Region, China (Recruiting)
• The Second Affiliated Hospital Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Not_yet_recruiting)

Study contacts

• Study coordinator: Chaoqiang Yang, Master

Conditions Triple-negative Breast Cancer