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

Trial details

Who runs it

Biotheus Inc.

Trial code

NCT05918133

Record updated

2025. március 11.

Original description

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.Read full original descriptionShow less

A Phase Ib/II Study of PM8002 Injection Plus Nab-paclitaxel as First Line Therapy for Unresectable, Locally Advanced or Metastatic Triple-negative Breast Cancer

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.

Inclusion: 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; Male or female, aged 18 to 75 years (including boundary value); 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; 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; Sufficient organ function; The Eastern Cooperative Oncology Group (ECOG) score of physical status is 0-1; Expected survival period ≥ 12 weeks; According to the RECIST1.1 standard, the subject has at least one measurable tumor lesion.

Exclusion: Previously received any antibody or inhibitor therapy targeting PD-1/PD-L1 or VEGF; 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]; 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; It is expected that any other form of anti-tumor drug treatment will be required during the study; History of severe allergic diseases, allergic history of serious drugs (including unlisted test drugs) or known allergic to any component of this test drug; Those who have active infection and currently need intravenous anti-infection treatment; Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; Known history of alcohol abuse, psychotropic substance abuse or drug abuse; Have a clear history of neurological or mental disorders, such as epilepsy, dementia and schizophrenia; Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS); Active tuberculosis, or a history of tuberculosis infection in the past but failed to control after treatment; 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); There is meningeal metastasis, uncontrollable or symptomatic central nervous system (CNS) metastasis; At present, there are uncontrollable pleural effusion, pericardium effusion and abdominal effusion; 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); Women who are pregnant or breastfeeding.

ClinicalTrials.gov NCT05918133