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TNBCPhase 1/2NCT05918133

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

A Phase 1/2 study testing PM8002 and nab-paclitaxel in people with TNBC, run by Biotheus Inc. at 8 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
TNBC
What is being tested?
PM8002 and nab-paclitaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
8 sitesChina
Study dates
1 Jul 2022to 30 Oct 2026
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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);
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  • 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;
  • Women who are pregnant or breastfeeding.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

China8 sites

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality

  • Affiliated Cancer Hospital of Harbin Medical University

    Harbin, Heilongjiang

  • The first ward of breast Surgery, Shandong Cancer Hospital

    Jinan, Shandong

  • Nanchang Third Hospital

    Nanchang, Jiangxi

  • Jiangsu Province Hospital

    Nanjing, Jiangsu

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality

  • Tian Jin Medicial University Cancer Institute&Hospital

    Tianjin, Tianjin Municipality

  • Yibin Second People's Hospital

    Yibin, Sichuan

Other trials in China

About this study

Official title: 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.

Read the 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
Being tested
PM8002, nab-paclitaxel
Keywords
First line

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05918133
Study groupRoleWhat they receive
PM8002+nab-paclitaxelOtherPM8002 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.
Receives: Drug: PM8002; Drug: nab-paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Up to approximately 2 years

  2. Treatment related adverse events (TRAEs)

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

    Measured: Up to 30 days after last treatment]

Secondary outcomes (4)

  1. Disease control rate (DCR)

    DCR is defined as the proportion of subjects with CR, PR, or stable disease(SD) based on RECIST v1.1.

    Measured: Up to approximately 2 years

  2. Duration of response (DoR)

    DoR is defined as the duration from the first documentation of objective response to the first documented disease progression (based on RECIST v1.1) or death due to any cause, whichever occurs first.

    Measured: Up to approximately 2 years

  3. Progression free survival (PFS)

    PFS is defined as the time from the start of treatment until the first documentation of disease progression or death due to any cause, whichever occurs first (based on RECIST v1.1).

    Measured: : Up to approximately 2 years

  4. Overall survival (OS)

    OS is the time from the date of first dosing date to death due to any cause.

    Measured: Up to approximately 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jun 2023
  2. Study start1 Jul 2022
  3. Primary completion30 Oct 2026 (estimated)
  4. Study completion30 Oct 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05918133
Sponsor's protocol ID
PM8002-B004C-TNBC-R
Status last verified
Nov 2024
First submitted
15 Jun 2023
Last updated
11 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The data will be published or presented for publications (poster, abstract,articles or papers) or any presentations.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing PM8002 and nab-paclitaxel in people with TNBC, run by Biotheus Inc. at 8 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (time frame: Up to approximately 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05918133.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2025.

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