JS207 Combination Therapy in Triple-negative Breast Cancer

NCT07045311 | Recruiting Phase 2

• 1 other identifier: JS207-008-II-TNBC
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 22

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.

Conditions

Triple-negative Breast Cancer

Outcome Measures

Primary Outcomes (1)

• ORR

  Objective response rate（ORR） evaluated based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria

  2years

Secondary Outcomes (9)

• DOR

  2years

• DCR

  2years

• PFS

  2years

• OS

  3years

• AE

  2years

Other Outcomes (1)

• Nectin-4 expression

  2years

Study Arms (2)

Cohort A

EXPERIMENTAL

Drug: JS207 in combination with 9MW2821

Cohort B

EXPERIMENTAL

Drug: JS207 in combination with Albumin paclitaxel

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)

Cohort A

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).

Cohort B

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Shanghai Junshi Bioscience Co., Ltd.: lead

Study Sites (22)

Anhui Provincial Cancer Hospital

Hefei, Anhui, 230000, China

NOT YET RECRUITING

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

RECRUITING

The Fifth Medical Center of PLA General Hospital

Beijing, Beijing Municipality, 100071, China

RECRUITING

Guangdong women and children's hospital and health institute

Guangzhou, Guangdong, 511400, China

NOT YET RECRUITING

Affiliated Hospital of Hebei University

Baoding, Hebei, 071030, China

RECRUITING

Harbin Medical University Affiliated Cancer Hospital

Harbin, Heilongjiang, 150001, China

NOT YET RECRUITING

Harbin Medical University Affiliated Cancer Hospital

Harbin, Heilongjiang, 150001, China

NOT YET RECRUITING

Henan Cancer Hospital

Zhangzhou, Henan, 450003, China

RECRUITING

Hubei Cancer Hospital

Wuhan, Hubei, 430079, China

RECRUITING

Jiangsu Cancer Hospital

Nanjing, Jiangsu, 210009, China

RECRUITING

Jiangsu Province Hospital

Nanjing, Jiangsu, 210029, China

NOT YET RECRUITING

Nanchang People'S Hospital

Nanchang, Jiangxi, 330000, China

NOT YET RECRUITING

Jilin University First Hospital

Changchun, Jilin, 130021, China

RECRUITING

The Second Hospital of Dalian Medical University

Dalian, Liaoning, 116027, China

RECRUITING

The First Hospital of China Medical University

Shenyang, Liaoning, 110002, China

RECRUITING

Liaoning Cancer Hospital&Institute

Shenyang, Liaoning, 110801, China

RECRUITING

Ceneral Hosipital of Ningxia Medical University

Yinchuan, Ningxia, 750000, China

NOT YET RECRUITING

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, 266035, China

RECRUITING

The First Affiliated Hospital of Xi'an Jiaotong University

Xian, Shanxi, 710061, China

RECRUITING

Xi'an International Medical Center Hospital

Xian, Shanxi, 710100, China

RECRUITING

Affiliated Tumor Hospital of Xinjiang Medical University

Ürümqi, Xinjiang Uygur Autonomous Region, 830000, China

RECRUITING

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

NOT YET RECRUITING

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Chaoqiang Yang, Master

CONTACT

18252095266; chaoqiang_yang@junshipharma.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: None(open label)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2025
• First Posted: July 1, 2025
• Study Start: September 17, 2025
• Primary Completion (Estimated): March 22, 2028
• Study Completion (Estimated): March 22, 2029
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (22)