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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Peking University People's Hospital
  Beijing, Beijing Municipality, China Recruiting
• The Fifth Medical Center of PLA General Hospital
  Beijing, Beijing Municipality, China Recruiting
• Affiliated Hospital of Hebei University
  Baoding, Hebei, China Recruiting
• Henan Cancer Hospital
  Zhangzhou, Henan, China Recruiting
• Hubei Cancer Hospital
  Wuhan, Hubei, China Recruiting
• Jiangsu Cancer Hospital
  Nanjing, Jiangsu, China Recruiting

Study contacts

• Study coordinator: Chaoqiang Yang, Master
• Email: chaoqiang_yang@junshipharma.com
• Phone: 18252095266

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Pre-Treatment Breast DCE-MRI AI Model to Predict Benefit from Neoadjuvant Chemo in Locally Advanced Triple-Negative Breast Cancer

  This study tests an AI model using pre-treatment breast MRI to see if it can identify which locally advanced triple-negative breast cancer patients will benefit most from neoadjuvant chemotherapy.

  Recruiting Fujian Cancer Hospital · Fuzhou, Fujian and 4 other locations · NCT07880600

• JS212-based therapy for recurrent/metastatic TNBC: as monotherapy or with partners

  This phase 2 study tests JS212 alone or with JS207 or JS001 to see if it helps people with recurrent or metastatic triple-negative breast cancer.

  Recruiting Phase 2 Shanghai Junshi Bioscience Co., Ltd. · Beijing, Beijing Municipality and 30 other locations · NCT07876557

• Imaging study of [68Ga]Ga-DWJ155 in adults with solid tumors

  This trial tests a new radioligand imaging agent, [68Ga]Ga-DWJ155, to see how well it images tumors and how safe it is in adults with advanced solid cancers.

  Recruiting at 2 sites Phase 1 Novartis · Darlinghurst, New South Wales and 1 other locations · NCT07801508

• Can older adults with breast cancer tolerate a dense CMF chemo schedule

  This study tests whether giving a condensed CMF chemotherapy regimen is feasible for people 70 and older with breast cancer.

  Recruiting at 7 sites Phase 2 Memorial Sloan Kettering Cancer Center · Basking Ridge, New Jersey and 6 other locations · NCT07768436

• Oral paclitaxel in triple-negative breast cancer before main chemotherapy

  This trial tests whether giving an oral paclitaxel dose-6 in combination with standard epirubicin and cyclophosphamide can be tolerated in women with triple-negative breast cancer before surgery.

  Recruiting Phase 1/2 The Affiliated Hospital Of Guizhou Medical University · Guiyang, Guizhou · NCT07739485

• Granzyme B-PET to see if immunotherapy works in TNBC

  This study will test whether a Granzyme B PET/CT scan can help predict how well immunotherapy will work for adults with locally advanced or metastatic triple-negative breast cancer receiving an immune checkpoint inhibitor.

  Recruiting Fudan University · Shanghai · NCT07705438

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.