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

NCT ID: NCT05918133

Last Updated: 2025-03-11

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-01
• Study Completion Date: 2026-10-30

Brief 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.

Conditions

TNBC

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PM8002+nab-paclitaxel

PM8002 at 20 mg/kg (Q2W) and nab-paclitaxel at 100 mg/m2 on the 1st, 8th, and 15th days of each cycle until unacceptable toxicity or disease progression were observed. Each cycle contains 28 days.

Group Type: OTHER

PM8002

Intervention Type: DRUG

IV infusion

nab-paclitaxel

Intervention Type: DRUG

IV infusion

Interventions

PM8002

IV infusion

Intervention Type: DRUG

nab-paclitaxel

IV infusion

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biotheus Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wu Jiong

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Affiliated Cancer Hospital of Harbin Medical University

Harbin, Heilongjiang, China

Jiangsu Province Hospital

Nanjing, Jiangsu, China

Nanchang Third Hospital

Nanchang, Jiangxi, China

The first ward of breast Surgery, Shandong Cancer Hospital

Jinan, Shandong, China

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Yibin Second People's Hospital

Yibin, Sichuan, China

Tian Jin Medicial University Cancer Institute&Hospital

Tianjin, Tianjin Municipality, China

Countries

China

Other Identifiers

PM8002-B004C-TNBC-R

Identifier Type: -

Identifier Source: org_study_id