NCT07045311 JS207 Combination Therapy in Triple-negative Breast Cancer
| NCT ID | NCT07045311 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Shanghai Junshi Bioscience Co., Ltd. |
| Condition | Triple-negative Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2025-09-17 |
| Primary Completion | 2028-03-22 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 80 participants in total. It began in 2025-09-17 with a primary completion date of 2028-03-22.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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；
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07045311 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Triple-negative Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07045311 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07045311 currently recruiting?
Yes, NCT07045311 is actively recruiting participants. Contact the research team at chaoqiang_yang@junshipharma.com for enrollment information.
Where is the NCT07045311 trial being conducted?
This trial is being conducted at Hefei, China, Beijing, China, Beijing, China, Guangzhou, China and 11 additional locations.
Who is sponsoring the NCT07045311 clinical trial?
NCT07045311 is sponsored by Shanghai Junshi Bioscience Co., Ltd.. The trial plans to enroll 80 participants.
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