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

Trial status:Recruitment Complete
Trial ID:
PM8002-B004C-TNBC-R
NCT ID:
NCT05918133
EudraCT ID:
N/A
EU Trial (CTIS) Number:
N/A
Sponsor:
The sponsor of a clinical trial is the company, institution or individual that takes responsibility for initiating, managing, and/or financing a clinical investigation. BioNTech collaborates with other pharmaceutical companies or institutions (collaborators) to develop certain new medicines. In particular cases BioNTech's collaborators are leading specific clinical trials and are acting as sponsors accordingly.
BioNTech SE
Collaborator:
N/A
Recruitment Complete

Trial Details

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.

Medical Condition
Unmapped
Study Drug
PM8002
See more
nab-paclitaxel
Phase
Phase 1/Phase 2
Type
Interventional
Estimated Enrolment
42
Estimated Trial Date
Jul 2022 - Oct 2026

Trial Participant Requirements

Age
18 - 75 Years
Sex
Female & Male
Healthy Volunteers
No
Inclusion and Exclusion 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.

Trial Locations

Location
Status
Location
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Status
Location
Affiliated Cancer Hospital of Harbin Medical University
Harbin, Heilongjiang, China
Status
Location
Jiangsu Province Hospital
Nanjing, Jiangsu, China
Status
Location
Nanchang Third Hospital
Nanchang, Jiangxi, China
Status
Location
The first ward of breast Surgery, Shandong Cancer Hospital
Jinan, Shandong, China
Status
Location
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Status
Go to page