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

Launched by BIOTHEUS INC. · May 14, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment option for women with inoperable locally advanced or metastatic triple-negative breast cancer (TNBC). The trial will compare the effectiveness of a treatment called PM8002 combined with Nab-Paclitaxel (a type of chemotherapy) to a placebo (a non-active substance) combined with Nab-Paclitaxel. The goal is to see if adding PM8002 can improve treatment outcomes for patients.

To be eligible for this trial, participants must be women aged 18 to 70 who have been diagnosed with TNBC that cannot be surgically removed. They should not have received any prior systemic treatments for advanced breast cancer, except for certain hormone therapies, and must be able to understand the study and provide written consent. Participants can expect to undergo regular check-ups and assessments throughout the study to monitor their health and response to treatment. This trial is currently recruiting, and it is important for potential participants to discuss their medical history and eligibility with their healthcare provider.

Gender

FEMALE

Eligibility criteria

• 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.