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Clinical Trials in China / NCT06419621
Active, not recruiting Phase 3

PM8002 or Placebo Plus Nab-Paclitaxel as First-line Treatment in Inoperable Locally Advanced/Metastatic TNBC

NCT06419621 · tracked via the Priya Life Science China tracker
Sponsor
Biotheus Inc.
Phase
Phase 3
Started
2024-06-11
Last updated
2026-07-29

Condition(s) studied

Triple Negative Breast Cancer(TNBC)

Investigational drug(s) / intervention(s)

PM8002Nab-PaclitaxelPlacebo

PM8002: PM8002 20 mg/kg via intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle

Nab-Paclitaxel: Nab-Paclitaxel 100mg/m2 via IV infusion on Days 1, 8, and 15 of each 28-day cycle

Placebo: Placebo 20 mg/kg via IV infusion on Days 1 and 15 of each 28-day cycle

Study summary

This multicenter, randomized, double-blind study will evaluate the safety and efficacy of PM8002 in combination with Nab-Paclitaxel compared with placebo combined with Nab-Paclitaxel as first-line treatment in inoperable locally advanced/metastatic triple-negative breast cancer(TNBC)

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: * Ability to understand and willing to provide written informed consent and to comply with scheduled visits and study procedures; * Female, aged 18 to 70 years (inclusive); * Histologically confirmed unresectable locally advanced or metastatic breast cancer with negative status for ER, PR, and HER-2. Testing results for all three markers conducted within 24 months prior to the initiation of the study by a local facility accredited by clinical research center are acceptable. If deemed necessary by the investigator during screening, subjects may provide additional biopsy to confirm the latest pathological; * Subjects who have not received prior systemic treatment(except endocrine therapy) for advanced breast cancer are eligible for the study. Subjects who have received Taxane-based chemotherapy during the neoadjuvant and/or adjuvant treatment phase are eligible, as long as the occurrence of relapse or metastasis is at least 12 months after the end of treatment; * Performance status as assessed by the Eastern Cooperative Oncology Group (ECOG) is 0-1; * Life expectancy of 12 weeks or more; * According to RECIST 1.1, the subject has at least 1 measurable lesion as the targeted lesion (the only bone metastasis or the only central nervous system metastasis should not be considered as a measurable lesion. A measurable lesion located at the previously irradiated radiation field or other local treatment area should not be selected as targeted lesion, unless the lesion shows unequivocal radiographic progression). Exclusion Criteria: * Previous treatment with immune checkpoint agonists (such as CD137 agonists) or immune checkpoint inhibitors (such as CTLA-4, PD-1, PD-L1, LAG3 monoclonal antibody, etc.) or anti-vascular endothelial growth factor (VEGF) target drugs; * Has uncontrolled or symptomatic brain or spine cord metastases; * Those who have had other active malignant tumors within 5 years prior to the study treatment, except for those that can be treated locally and have been cured ; * Poorly controlled hypertension (systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg); * With a history of hypertensive crisis or hypertensive encephalopathy; * With a history of abdominal fistula, tracheoesophageal fistula, gastrointestinal perforation, or intra-abdominal abscess within the last 6 months prior to the start of the study treatment; * Adverse events resulting from prior anti-tumor therapies should be assessed and graded according to the CTCAE 5.0 criteria, subjects whose AEs have not returned to Grade 1 or below; * Has uncontrollable pleural, pericardial, or abdominal effusions; * Has received allogeneic hematopoietic stem cell transplantation or organ transplantation.

Primary outcome measure(s)

Trial sites (70)

FacilityCityRegionStatus
The first affiliated hospital of bengbu medical University Bengbu Anhui
The First Affiliated Hospital of Anhui Medical University Hefei Anhui
Cancer Hospital Chinese Academy of Medical Sciences Beijing Beijing Municipality
Fifth Medical Center of Chinese PLA General Hospital Beijing Beijing Municipality
Chongqing University Cancer Hospital Chongqing Chongqing Municipality
The First Affiliated Hospital of Chongqing Medical University Chongqing Chongqing Municipality
The Southwest Hospital of Army Medical University Chongqing Chongqing Municipality
Fujian Provincial Cancer Hospital Fuzhou Fujian
Lanzhou University First Hospital Lanzhou Gansu
The First People's Hospital of Foshan Foshan Guangdong
Affillated Cancer Hospital and Institute of Guangzhou Medical University Guangzhou Guangdong
Sun Yat-sen Memorial Hospital Affiliated to Sun Yat-sen University Guangzhou Guangdong
Sun Yat-sen University Cancer Center Guangzhou Guangdong
Yuebei People's Hospital Shaoguan Guangdong
Guangxi Medical University Cancer Hospital Nanning Guangxi
The First Affiliated Hospital of Guangxi Medical University Nanning Guangxi
Affiliated Hospital of Hebei University Baoding Hebei
The Fourth Hospital of Hebei Medical University Shijiazhuang Hebei
Harbin Medical University Cancer Hospital Harbin Heilongjiang
The Affiliated Anyang Tumor Hospital of Henan University of Science and Technology Anyang Henan
The First Affiliated Hospital of Henan University of Science and Technology Luoyang Henan
Nanyang Central Hospital Nanyang Henan
The First Affiliated Hospital of Xinxiang Medical University Xinxiang Henan
Henan Cancer Hospital Zhengzhou Henan
The First Affiliated Hospital of Zhengzhou University Zhengzhou Henan
Hubei Cancer Hospital Wuhan Hubei
Union Hospital Tongji Medical College of Hust Wuhan Hubei
Zhongnan Hospital of Wuhan University Wuhan Hubei
The First People's Hospital of Changde City Changde Hunan
Hunan Cancer Hospital Changsha Hunan
Xiangyang Cancer Hospital Xiangyang Hunan
The Central Hospital of Yongzhou Yongzhou Hunan
Jiangsu Province Hospital Nanjing Jiangsu
The Affiliated Hospital of Nantong University Nantong Jiangsu
The Second Affiliated Hospital of Suzhou University Suzhou Jiangsu
Xuzhou Central Hospital Xuzhou Jiangsu
Northern Jiangsu People's Hospital Yangzhou Jiangsu
Jiangxi Cancer Hospital Nanchang Jiangxi
Jilin Cancer Hospital Changchun Jilin
The First Hospital of Jilin University Changchun Jilin

+ 30 more sites — see the full list on the official registry below.

More Biotheus Inc. trials in China

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06419621 on ClinicalTrials.gov ↗ ← All trials in China