---
title: JS207 Combination Therapy in Triple-negative Breast Cancer
nct_id: NCT07045311
overall_status: RECRUITING
phase: PHASE2
sponsor: Shanghai Junshi Bioscience Co., Ltd.
study_type: INTERVENTIONAL
primary_condition: Triple-negative Breast Cancer
countries: China
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT07045311.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT07045311"
ct_last_update_post_date: 2026-04-15
last_seen_at: "2026-05-12T07:21:15.715Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# JS207 Combination Therapy in Triple-negative Breast Cancer

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

**NCT ID:** [NCT07045311](https://clinicaltrials.gov/study/NCT07045311)

## Key Facts

- **Status:** RECRUITING
- **Phase:** PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 80
- **Lead Sponsor:** Shanghai Junshi Bioscience Co., Ltd.
- **Conditions:** Triple-negative Breast Cancer
- **Start Date:** 2025-09-17
- **Completion Date:** 2029-03-22
- **CT.gov Last Update:** 2026-04-15

## 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.

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 75 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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；
```

## Arms

- **Cohort A** (EXPERIMENTAL)
- **Cohort B** (EXPERIMENTAL)

## Interventions

- **JS207 in combination with 9MW2821** (DRUG) — 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 paclitaxel** (DRUG) — 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).

## Primary Outcomes

- **ORR** _(time frame: 2years)_ — Objective response rate（ORR） evaluated based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria

## 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)_

## Locations (22)

- 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_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.anhui provincial cancer hospital|hefei|anhui|china` — added _(2026-05-12)_
- `locations.peking university people's hospital|beijing|beijing municipality|china` — added _(2026-05-12)_
- `locations.the fifth medical center of pla general hospital|beijing|beijing municipality|china` — added _(2026-05-12)_
- `locations.guangdong women and children's hospital and health institute|guangzhou|guangdong|china` — added _(2026-05-12)_
- `locations.affiliated hospital of hebei university|baoding|hebei|china` — added _(2026-05-12)_
- `locations.harbin medical university affiliated cancer hospital|harbin|heilongjiang|china` — added _(2026-05-12)_
- `locations.henan cancer hospital|zhangzhou|henan|china` — added _(2026-05-12)_
- `locations.hubei cancer hospital|wuhan|hubei|china` — added _(2026-05-12)_
- `locations.jiangsu cancer hospital|nanjing|jiangsu|china` — added _(2026-05-12)_
- `locations.jiangsu province hospital|nanjing|jiangsu|china` — added _(2026-05-12)_
- `locations.nanchang people's hospital|nanchang|jiangxi|china` — added _(2026-05-12)_
- `locations.jilin university first hospital|changchun|jilin|china` — added _(2026-05-12)_
- `locations.the second hospital of dalian medical university|dalian|liaoning|china` — added _(2026-05-12)_
- `locations.the first hospital of china medical university|shenyang|liaoning|china` — added _(2026-05-12)_
- `locations.liaoning cancer hospital&institute|shenyang|liaoning|china` — added _(2026-05-12)_
- `locations.ceneral hosipital of ningxia medical university|yinchuan|ningxia|china` — added _(2026-05-12)_
- `locations.the affiliated hospital of qingdao university|qingdao|shandong|china` — added _(2026-05-12)_
- `locations.the first affiliated hospital of xi'an jiaotong university|xian|shanxi|china` — added _(2026-05-12)_
- `locations.xi'an international medical center hospital|xian|shanxi|china` — added _(2026-05-12)_
- `locations.affiliated tumor hospital of xinjiang medical university|ürümqi|xinjiang uygur autonomous region|china` — added _(2026-05-12)_
- `locations.the second affiliated hospital zhejiang university school of medicine|hangzhou|zhejiang|china` — added _(2026-05-12)_

---

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