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

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 is a phase II interventional study divided into two parts, with a safety run-in followed by a cohort expansion. Part 1 assigns JS212 as a standalone therapy or with JS207 depending on PD-L1 status; Part 2 tests JS212 plus JS001. Participants have unresectable locally advanced or metastatic TNBC with limited prior systemic therapy. Key eligibility includes age 18-70, measurable disease, good organ function, ECOG 0-1, and no active CNS metastases. Exclusion criteria include uncontrolled effusions, risk of hemorrhage, and active autoimmune disease requiring treatment. The study aims to preliminarily assess efficacy and safety of these regimens in this patient population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Male or female age 18-70 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（cohort expansion period); only one line of prior systemetic treatment for locally advanced or metastatic TNBC;
5. Adequate organ function;
6. ECOG performance status of 0 or 1;
7. Life expectancy 12 weeks;
8. 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. History of immunodeficiency. Presence of active tuberculosis, hepatitis B, or hepatitis C;
9. Severe cardiovascular disease;
10. Serious infection (CTCAE 6.0 Grade\>2) within 28 days prior to the first dose of study drug;
11. Previous treatment of any anti-VRGF drugs targeting VEGF (part 1) or ADC drugs targeting EGFR and/or HER3;
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, China Recruiting
• The Fifth Medical Center of Chinese PLA General Hospital
  Beijing, Beijing Municipality, China Not yet recruiting
• Peking University Shougang Hospital
  Beijing, Beijing Municipality, China Not yet recruiting
• Fujian Cancer Hospital
  Fuzhou, Fujian, China Not yet recruiting
• The First Hospital of Lanzhou University
  Lanzhou, Gansu, China Not yet recruiting
• Sun Yat-sen University Cancer Center
  Guangzhou, Guangdong, China Not yet recruiting

Study contacts

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

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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.