A Study of PM8002 Plus Nab-paclitaxel as First Line Therapy for TNBC

Trial Title: A Study of PM8002 Plus Nab-paclitaxel as First Line Therapy for TNBC

NCT ID: NCT05918133

Condition: TNBC

Conditions: Official terms:
Paclitaxel

Conditions: Keywords:
First line

Study type: Interventional

Study phase: Phase 1/Phase 2

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: PM8002
Description: IV infusion
Arm group label: PM8002+nab-paclitaxel

Intervention type: Drug
Intervention name: nab-paclitaxel
Description: IV infusion
Arm group label: PM8002+nab-paclitaxel

Summary: Here, the investigators present the results from a Phase Ib/II study of PM8002 in combination with nab-paclitaxel in subjects with locally advanced or metastatic triple negative breast cancer without previous systematic treatment.

Detailed description: PD-L1 and VEGF play important roles in immune escape and tumor angiogenesis and enhance cancer growth and metastasis. PM8002 is a bispecific antibody targeting PD-L1 and VEGF-A. Here, the investigators present the results from a Phase Ib/II study of PM8002 in combination with nab-paclitaxel in subjects with locally advanced or metastatic triple negative breast cancer without previous systematic treatment.

Criteria for eligibility:
Criteria:
Inclusion Criteria: 1. Voluntarily participate in clinical research; fully understand the study and voluntarily sign the informed consent; willing to follow and have the ability to complete all trial procedures; 2. Male or female, aged 18 to 75 years (including boundary value); 3. Unresectable locally advanced or metastatic breast cancer confirmed by histology or cytology, ER, PR, HER-2 are all negative. Negative ER and PR were defined as: IHCER < 1%, IHCPR < 1%. HER-2 negative is defined as: IHCHER-2 (-) or (1+), HER-2 (2+) must be tested by FISH and the result is negative. 4. Patients who have not received systemic treatment for advanced TNBC in the past are allowed to use taxane anti-tumor therapy in the previous neoadjuvant and/or adjuvant treatment stage, but must meet the end time of taxane neoadjuvant and/or adjuvant treatment Recurrence/metastasis interval ≥ 12 months; 5. Sufficient organ function; 6. The Eastern Cooperative Oncology Group (ECOG) score of physical status is 0-1; 7. Expected survival period ≥ 12 weeks; 8. According to the RECIST1.1 standard, the subject has at least one measurable tumor lesion. Exclusion Criteria: 1. History of severe allergic diseases, allergic history of serious drugs (including unlisted test drugs) or known allergic to any component of this test drug; 2. Previously received any antibody or inhibitor therapy targeting PD-1/PD-L1 or VEGF; 3. There is meningeal metastasis, uncontrollable or symptomatic central nervous system (CNS) metastasis; 4. Those who have active infection and currently need intravenous anti-infection treatment; 5. At present, there are uncontrollable pleural effusion, pericardium effusion and abdominal effusion; 6. Before the start of the study and treatment, fever of unknown cause > 38.5°C (according to the researcher's judgment, fever caused by tumor can be included in the group); 7. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 8. Known history of alcohol abuse, psychotropic substance abuse or drug abuse; 9. Have a clear history of neurological or mental disorders, such as epilepsy, dementia and schizophrenia; 10. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS); 11. Syphilis nonspecific antibody test is positive (such as TRUST and PRP) or syphilis specific antibody test is positive (such as TPPA) [it is acceptable that "Syphilis specific antibody test" is positive but "Syphilis nonspecific antibody test" is negative for more than one year]; 12. Active tuberculosis, or a history of tuberculosis infection in the past but failed to control after treatment; 13. Active hepatitis B (HBsAg positive and HBV-DNA ≥1 1000 IU/ml) can be controlled by antiviral drugs (HBV-DNA < 1000 IU/ml). Active hepatitis C (HCV-RNA > detection limit of research center); 14. According to the researcher's judgment, the subject's basic illness may increase the risk of receiving the study drug, or confuse the explanation of the toxic reaction and AE; 15. It is expected that any other form of anti-tumor drug treatment will be required during the study; 16. Women who are pregnant or breastfeeding.

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Locations:

Facility:
Name: Fudan University Shanghai Cancer Center

Address:
City: Shanghai
Country: China

Status: Recruiting

Contact:
Last name: Jiong Wu

Phone: +86 136 0163 7369
Email: wujiong1122@vip.sina.com

Start date: July 1, 2022

Completion date: October 30, 2026

Lead sponsor:
Agency: Biotheus Inc.
Agency class: Industry

Source: Biotheus Inc.

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05918133