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Triple-negative Breast CancerPhase 1/2NCT04750382

A Study of HX008 for the Treatment of Patients With Metastatic Triple Negative Breast Cancer

A Phase 1/2 study testing HX008+Cisplatin+Gemcitabine in people with Triple-negative Breast Cancer, run by Taizhou Hanzhong biomedical co. LTD at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

HX008 is a humanized monoclonal antibody targeting PD-1 on T cell surface, restores T cell activity, thus enhancing immune response and has potential to treat various types of tumors. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Triple-negative Breast Cancer
What is being tested?
HX008+Cisplatin+Gemcitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
1 siteChina
Study dates
15 Jul 2019to 1 Dec 2021
Phase
Phase 1/2
Are there results?
None posted in the registry

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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Provide written informed consent voluntarily. Understand this protocol and be willing and able to adhere to the study visit schedule.
  • Age 18-70 years old, male or female.
  • Diagnosed with stage IV or recurrent or metastatic TNBC who are not suitable for surgical treatment.
  • Histopathology shows that ER, PR and HER-2 are all negative. If metastasis exists, the histopathology result of metastasis is preferred. ER and PR negative are defined as ER < 1% and PR < 1%. HER-2 negative is defined as HER-2 (-) or (+) in immunohistochemical test. For HER-2 (++), additional negative result should be observed in FISH test. For HER-2 (-) or (+), FISH test is optional, but the result should be negative.
  • Have not been treated with any chemotherapy drugs for recurrent and metastatic triple negative breast cancer (adjuvant / neoadjuvant therapy is allowed, if the time between the last dose of drug and recurrence or metastasis is more than 6 months).
  • Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Score.
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  • Life expectancy ≥ 3 months.
  • Has at least one measurable extracranial lesion according to RECIST1.1, which has not been treated with radiotherapy.
  • Has sufficient organ and bone marrow function to meet the following laboratory examination standards:
  • Blood routine: absolute neutrophil count (ANC)≥1.5×10^9/L; while blood cell count (WBC)≥3×10^9/L; platelet count (PLT)≥100×10^9/ L; hemoglobin (HGB)≥90 g/L (without blood transfusion within 14 days prior to enrollment);
  • Renal function: serum creatinine (Scr) ≤1.5×ULN, and endogenous creatinine clearance is more than 50 ml / min (Cockcroft Gault formula);
  • Liver function: TBIL≤1.5×ULN; Patients without liver metastases require alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5× ULN. Patients with liver metastases require: ALT and AST≤5×ULN;
  • The coagulation function is adequate, which is defined as the international normalized ratio (INR) ≤ 2×ULN; or activated partial thromboplastin time (APTT)≤ 1.5×ULN (except for those who are receiving anticoagulant therapy if their PT/APTT are within the expected values);
  • Reproductive men and women of childbearing age are willing to take effective contraceptive measures (such as oral contraceptives, intrauterine contraceptives, sexual abstinence or barrier contraceptives combined with spermicide) from signing the informed consent form to 12 months after the last administration of the trial drug.

Who cannot join

  • Suffered from other malignant tumors in the past 5 years, except carcinoma in situ from cervix or skin basal cell carcinoma that has been cured.
  • With adverse reactions of previous treatment that have not be recovered to CTCAE V5.0 grade ≤ 1, except for the residual hair loss effect.
  • Had prior treatment with any anti-PD-1, PD-L1 or CTLA-4 therapies.
  • Participants with active or a history of autoimmune diseases that probably will recur (e.g. systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune thyroid disease, multiple sclerosis, vasculitis, glomerulitis, etc.), or with high risk (e.g. organ transplantation requiring immunosuppressive therapy). However, participants with the following diseases are eligible: skin diseases requiring no systemic treatment (such as eczema, skin rash covering less than 10% of the body surface, psoriasis without ophthalmic symptoms, etc.).
  • Expected to undergo major surgery during the study treatment or within 28 days before the first administration of the study drug (excluding surgery for diagnostic purpose).
  • Need to receive systemic corticosteroids (dose equivalent to > 10 mg prednisone / day) or other immunosuppressive drugs within 14 days before enrollment or during the study period. Those under the following conditions are eligible: a) Locally external use or inhaled corticosteroids; b) short-term (≤ 7 days) use of glucocorticoids for the prevention or treatment of non-autoimmune allergic diseases.
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  • Has active digestive ulcer, incomplete intestinal obstruction, active gastrointestinal hemorrhage or perforation.
  • Has active interstitial pneumonia, pulmonary fibrosis, acute pulmonary disorders, acute radiation pneumonitis, et al.
  • Has uncontrolled systemic diseases, such as cardiovascular and cerebrovascular diseases (unstable angina pectoris, etc.), diabetes, hypertension, tuberculosis, etc;
  • Has a history of HIV infection, or other acquired or innate immune deficiency disorders, or a history of organ or stem-cell transplantation.
  • Has active chronic HBV or HCV infection, except those with HBV DNA viral load ≤500 IU/mL or <10^3 copies/mL, or HCV RNA negative after adequate treatment.
  • Has severe infection within 4 weeks or active infection requiring IV infusion or oral administration of antibiotics within 2 weeks prior to the first dose of the study drug.
  • Known to be allergic to macromolecular protein agents or monoclonal antibody; Known to has a history of severe allergies (CTCAE v5.0 ≥ grade 3) to any of the components in the study drug.
  • Has participated in other clinical trial within 4 weeks before the first administration of the study drug.
  • Alcohol dependence or drug abuse within recent one year.
  • Has a history of confirmed neurological or mental disorders, such as epilepsy, dementia; or with poor compliance; or the presence of peripheral neurological disorders.
  • Has symptomatic central nervous system metastasis.
  • Participants with asymptomatic central nervous system metastasis with or without treatment, who have no disease progression by CT / MRI examination, and whose interval from the last radiotherapy is more than 4 weeks, can be enrolled.
  • Participants with uncontrollable pleural effusion, peritoneal effusion or pericardial effusion requiring repeated drainage within 7 days before enrollment.
  • Participants who had received hematopoietic stimulating factors such as colony stimulating factor and erythropoietin within 2 weeks prior to the first dose of study drug
  • Is pregnant or breastfeeding.
  • Other reasons disqualifying the entering of this study based on the evaluation of the investigators.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality

Other trials in China

About this study

Official title: A Single-armed Multicenter Phase Ib / II Study of HX008 (a Recombinant Humanized Anti-PD-1 Monoclonal Antibody) Combined With GP Regimen as the First-line Treatment in Patients With Metastatic Triple Negative Breast Cancer

HX008 is a humanized monoclonal antibody targeting PD-1 on T cell surface, restores T cell activity, thus enhancing immune response and has potential to treat various types of tumors. In this study, the safety and preliminary efficacy of HX008+cisplatin+gemcitabine for the treatment of patients with metastatic triple-negative breast cancer will be evaluated.

Being tested
HX008+Cisplatin+Gemcitabine
Medical subject headings
Triple Negative Breast Neoplasms

What participants receive

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

  • HX008+Cisplatin+GemcitabineDrug

    Participants will receive HX008 3mg/kg, Day 1,Q3W for up to 2 years + Cisplatin 75mg/m^2, Day 1, Q3W for up to 6 cycles +Gemcitabine 1250mg/m^2, Day 1, Day 8, Q3W for up to 6 cycles

Study groups in NCT04750382
Study groupRoleWhat they receive
HX008+Cisplatin+GemcitabineExperimentalNot described
Receives: Drug: HX008+Cisplatin+Gemcitabine

What is being measured

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

  1. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

    Measured: 24 months

  2. 1-year progression-free survival rate

    The rate of participants who neither experience disease progression nor death

    Measured: 24 months

Secondary outcomes (4)

  1. Objective Response Rate (ORR)

    Percentage of subjects achieving complete response (CR) and partial response (PR) according to RECIST1.1 and iRECIST.

    Measured: 12 months

  2. Duration of Response (DOR)

    Disease Control Rate (DCR) refers to the proportion of subjects who achieve CR, PR and SD through imaging evaluation.

    Measured: 24 months

  3. Overall survival (OS)

    Overall survival (OS) refers to the time from the first study drug treatment to death due to any cause.

    Measured: 24 months

  4. Progression-Free Survival (PFS)

    Progression-free survival (PFS) is defined as the time from the first study drug treatment to disease progression (PD) or to death of the subject due to any reason.

    Measured: 24 months

Timeline

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

  1. First posted11 Feb 2021
  2. Study start15 Jul 2019
  3. Primary completion1 Dec 2020
  4. Study completion1 Dec 2021 (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
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04750382
Sponsor's protocol ID
HX008-Ib/II-TNBC-01
Status last verified
Feb 2021
First submitted
8 Feb 2021
Last updated
11 Feb 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing HX008+Cisplatin+Gemcitabine in people with Triple-negative Breast Cancer, run by Taizhou Hanzhong biomedical co. LTD at 1 site 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 14 inclusion and 22 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: status not confirmed, as of the sponsor's last update on 11 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Results are not available in the source record.

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?

Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 (time frame: 24 months). 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 NCT04750382.

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 Feb 2021.

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