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

NCT05918133 | Active Not Recruiting Phase 1

• 1 other identifier: PM8002-B004C-TNBC-R
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 8

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.

Conditions

TNBC

Keywords

First line

Outcome Measures

Primary Outcomes (2)

• Objective Response Rate

  Objective response rate (ORR) is the proportion of subjects with complete response (CR) or partial response (PR), based on RECIST v1.1

  Up to approximately 2 years

• Treatment related adverse events (TRAEs)

  The incidence and severity of TRAEs graded according to NCI-CTCAE v5.0

  Up to 30 days after last treatment]

Secondary Outcomes (4)

• Disease control rate (DCR)

  Up to approximately 2 years

• Duration of response (DoR)

  Up to approximately 2 years

• Progression free survival (PFS)

  : Up to approximately 2 years

• Overall survival (OS)

  Up to approximately 2 years

Study Arms (1)

PM8002+nab-paclitaxel

OTHER

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.

Drug: PM8002; Drug: nab-paclitaxel

Interventions

PM8002 DRUG

IV infusion

PM8002+nab-paclitaxel

nab-paclitaxel DRUG

IV infusion

PM8002+nab-paclitaxel

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• History of severe allergic diseases, allergic history of serious drugs (including unlisted test drugs) or known allergic to any component of this test drug;
• Previously received any antibody or inhibitor therapy targeting PD-1/PD-L1 or VEGF;
• There is meningeal metastasis, uncontrollable or symptomatic central nervous system (CNS) metastasis;
• Those who have active infection and currently need intravenous anti-infection treatment;
• 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);
• 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);
• Syphilis nonspecific antibody test is positive (such as TRUST and PRP) or syphilis specific antibody test is positive (such as TPPA) \[it is acceptable that "Syphilis specific antibody test" is positive but "Syphilis nonspecific antibody test" is negative for more than one year\];
• 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);
• 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;

Sponsors & Collaborators

• Biotheus Inc.: lead

Study Sites (8)

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Location

Affiliated Cancer Hospital of Harbin Medical University

Harbin, Heilongjiang, China

Location

Jiangsu Province Hospital

Nanjing, Jiangsu, China

Location

Nanchang Third Hospital

Nanchang, Jiangxi, China

Location

The first ward of breast Surgery, Shandong Cancer Hospital

Jinan, Shandong, China

Location

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Location

Yibin Second People's Hospital

Yibin, Sichuan, China

Location

Tian Jin Medicial University Cancer Institute&Hospital

Tianjin, Tianjin Municipality, China

Location

MeSH Terms

Interventions

130-nm albumin-bound paclitaxel

Study Officials

• Wu Jiong

  Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2023
• First Posted: June 26, 2023
• Study Start: July 1, 2022
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: March 11, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Time Frame: After the trial completed.
• Access Criteria: NCI is committed to sharing data in accordance with NIH policy.

Locations

CN (8)