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Triple Negative Breast CancerPhase 1NCT03251313

PD-1(Programmed Death-1) Antibody +GP as First Line Treatment for Triple Negative Breast Cancer(TNBC) Patients

A Phase 1 study testing JS001 120mg+GP, JS001 240mg+GP and JS001 480mg+GP in people with Triple Negative Breast Cancer, run by Fudan University 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 The sponsor has not verified this record for over two years, so it may be out of date.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

This is a Phase I dose escalation trial to assess dose-limiting toxicity (DLT) and MTD of JS001+GP in advanced/metastatic TNBC patients, and to determine the recommended Phase II dose and the best combination regimen. Read more about this study

Who is it for?
Ages 18 to 70 years, women only
Conditions the study is for
Triple Negative Breast Cancer
What is being tested?
JS001 120mg+GP, JS001 240mg+GP and JS001 480mg+GP
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
1 siteChina
Study dates
15 May 2019to 30 Dec 2022
Phase
Phase 1
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
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed relapsed or metastatic triple negative breast cancer
  • Subjects must have normal organ and marrow function as defined below:
  • White blood cell ≥ 3,000/μL, Absolute neutrophil count ≥ 1,500/μL, Hemoglobin ≥ 9.0 g/dl, Platelet count ≥ 100,000/μL
  • Total bilirubin ≤1.25 X institutional upper limit of normal , aspartate aminotransferase(AST) ≤ 2.5 X institutional upper limit of normal, alanine transaminase(ALT) ≤ 2.5 X institutional upper limit of normal (For patients with liver metastasis, Total bilirubin ≤1.5 X institutional upper limit of normal , AST ≤5 X institutional upper limit of normal, ALT ≤5 X institutional upper limit of normal)
  • Serum creatinine within normal institutional limits
  • thyroid-stimulating hormone ,FT3(free triiodothyronine),FT4(Free thyroid hormone) within 0.9 X institutional lower limit of normal to 1.1 X institutional upper limit of normal (Except for patients who had thyroid ectomy)
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  • Basically normal EKG and left ventricular ejection fraction(LVEF)>50%
  • Life expectancy of 6 months or more
  • Performance Status 0-1
  • Subjects must have at least one measurable disease per RECIST v1.1
  • Weight more than 45 Kilogram
  • Subjects must have not received chemotherapy in metastatic setting, subjects relapsed 6 months after the completion of adjuvant therapy are eligible
  • Subjects must be willing to supply fresh or archive tumor tissue for research purposes
  • Subjects must have stopped receiving any anti-cancer treatment (including chemotherapy, curative radiotherapy, and surgery or targeting therapy) for at least 4 weeks.
  • Subjects must have stopped receiving systemic immunosuppressive agents for at least 2 weeks.
  • Subjects must have the ability to understand and the willingness to sign a written informed consent document

Who cannot join

  • Subjects with radiographically stable treated brain metastases are eligible but must not have been on steroid therapy for at least 4 weeks
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to Gemcitabine, cisplatin or JS001
  • Patients who have adjuvant chemotherapy and relapsed within 6 months.
  • Pregnant or breastfeeding women are excluded from this study
  • Patients with HIV infection, patients with positive HbsAg or HCV(hepatitis C virus)-RNA
  • Patients with chronic autoimmune disease
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  • Patients with prior therapy with antibodies that modulate T-cell function (e.g., anti-PD-1, anti-PD-L1, anti-CTLA-4(Cytotoxic T-lymphocyte-associated protein 4))
  • Patients with evidence of active, non-infectious pneumonia
  • Patients with a history of tuberculosis
  • Patients active infection requiring intravenous systemic therapy
  • Severe cardiovascular disease
  • Severe gastrointestinal dysfunction (bleeding, infection, obstruction or ≥ grade 1 diarrhea)
  • Patients with severe coagulation dysfunction or bleeding tendency, patients who are receiving thrombolysis or anticoagulation therapy
  • Subjects with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, severe hyper blood pressure, severe diabetes or severe thyroid disease that would limit compliance with study requirements
  • Patients with known psychiatric disorders that would interfere with cooperation with requirements of the trial
  • Patients who have received a vaccine within 4 weeks prior to the first dose of JS001
  • Patients with a known additional malignancy that is progressing or requires active treatment (within the last 5 years). Exceptions: basal cell carcinoma of the skin, squamous cell carcinoma of the skin or in situ cancers that has undergone potentially curative therapy

Trial locations and contacts

1 site in 1 country.

China1 site

  • Fudan University Shanghai Cancer Center

    Shanghai, 200032

Other trials in China

About this study

Official title: Recombinant Humanized PD-1 Monoclonal Antibody (JS001) Combined With Gemcitabine and Cisplatin (GP) as First Line Treatment for Triple Negative Breast Cancer patients-a Phase 1 Clinical Trial

This is a Phase I dose escalation trial to assess dose-limiting toxicity (DLT) and MTD of JS001+GP in advanced/metastatic TNBC patients, and to determine the recommended Phase II dose and the best combination regimen.

Read the detailed description

There will be 3 stages in this trial. Stage 1 is the dose escalation stage. JS001 will be tested in combination with GP in 3 dose levels.

Level 1: 120mg Level 2: 240mg Level 3: 480mg Patients will receive JS001+GP for 6 cycles and JS001 maintenance therapy for up to approximately 2 years.

JS001 will be given on d1 every 3 weeks with GP and every 2 weeks in maintenance therapy.

The first group of participants will receive the lowest dose level of JS001 at 120mg. Each new group will receive a higher dose of JS001 than the group before it until 480mg.

Stage 2 is the dose expansion stage. Dose expansion will be carried out to expand to 12 patients in the highest dose level at which the patient can tolerate well. This dose will also be recommended as phase 2 dose(RP2D).

Stage 3 is the sequential treatment stage. Patients receive 6 cycles of GP without JS001 and then receive JS001 maintenance therapy for up to approximately 2 years.

Being tested
JS001 120mg+GP, JS001 240mg+GP, JS001 480mg+GP, GP followed by JS001
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.

  • JS001 120mg+GPCombination product

    In this arm, JS001 120mg will be given at d1; Gem 1000mg/m2 d2,9; DDP(cisplatin) 75mg/m2 d2

  • JS001 240mg+GPCombination product

    In this arm, JS001 240mg will be given at d1; Gem 1000mg/m2 d2,9; DDP 75mg/m2 d2

  • JS001 480mg+GPCombination product

    In this arm, JS001 480mg will be given at d1; Gem 1000mg/m2 d2,9; DDP 75mg/m2 d2

  • GP followed by JS001Combination product

    In this arm,Patients receive 6 cycles of GP without JS001 and then receive JS001 maintenance therapy for up to approximately 2 years. JS001 will be given at RP2D.

Study groups in NCT03251313
Study groupRoleWhat they receive
JS001 120mg+GPExperimentalLevel 1: JS001 120mg +GP q3w,*6 cycles, then JS001 120mg q3w for maintenance therapy for up to approximately 2 years.
Receives: Combination Product: JS001 120mg+GP
JS001 240mg+GPExperimentalLevel 2: JS001 240mg +GP q3w,*6 cycles, then JS001 240mg q3w for maintenance therapy for up to approximately 2 years.
Receives: Combination Product: JS001 240mg+GP
JS001 480mg +GPExperimentalLevel 3: JS001 480mg+GP q3w,*6 cycles, then JS001 480mg q3w for maintenance therapy for up to approximately 2 years.
Receives: Combination Product: JS001 480mg+GP
GP followed by JS001Experimentalsequential treatment: Patients receive 6 cycles of GP without JS001 and then receive JS001 maintenance therapy for up to approximately 2 years. JS001 will be given at RP2D.
Receives: Combination Product: GP followed by JS001

What is being measured

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

  1. Maximum Tolerated Dose (MTD) of JS001 when combined with GP

    If 1/6 patients has grade 3 or higher toxicity then escalation proceeds, if 2/6 has grade 3 or greater toxicity then this is declared MTD.

    Measured: 3 weeks

Secondary outcomes (12)

  1. Peak Plasma Concentration (Cmax)

    Cmax of JS001

    Measured: 85 days

  2. Area under the plasma concentration versus time curve (AUC)

    AUC of JS001

    Measured: 85 days

  3. other pharmacokinetics(PK) characteristics of JS001+GP

    half life of JS001

    Measured: 85 days

  4. Incidence of Treatment-Emergent Adverse Events

    Incidence of Adverse Events that need to be treated immediately

    Measured: 85 days

  5. Incidence of Severe Adverse Events

    Incidence of Adverse Events that cause hospitalization, inability, death, etc

    Measured: 85 days

  6. objective response rate of JS001+GP

    objective response rate(%) is the sum of CR(complete remission) rate and PR(partial remission) rate

    Measured: 1 year

  7. disease control rate of JS001+GP

    disease control rate(%) is the sum of CR rate and PR rate and SD(stable disease) rate for more than 6 weeks

    Measured: 1 year

  8. duration of regression of JS001+GP

    duration of regression(months) is the time interval from randomization to disease progression

    Measured: 1 year

  9. time to regression of JS001+GP

    time to regression(months) is the time interval from randomization to disease regressin

    Measured: 1 year

  10. progression free survival of JS001+GP

    progression free survival(months) is the time interval from randomization to disease progression or death from any reason

    Measured: 1 year

  11. overall survival of JS001+GP

    overall survival(months) is the time interval between randomization and death from any reason

    Measured: 1 year

  12. best combination regimen

    Is JS001 combined with GP or GP followed by JS001 better in safety (incidence of grade 3-4 toxicity) and efficacy(Response Rate and PFS)

    Measured: 1 year

Timeline

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

  1. First posted16 Aug 2017
  2. Study start15 May 2019
  3. Primary completion30 Dec 2022 (estimated)
  4. Study completion30 Dec 2022 (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
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03251313
Sponsor's protocol ID
Fudan-P1-201701
Status last verified
Apr 2022
First submitted
7 Jun 2017
Last updated
20 Apr 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing JS001 120mg+GP, JS001 240mg+GP and JS001 480mg+GP in people with Triple Negative Breast Cancer, run by Fudan University 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 16 inclusion and 17 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 20 Apr 2022. 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 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.

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?

Maximum Tolerated Dose (MTD) of JS001 when combined with GP (time frame: 3 weeks). 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 NCT03251313.

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 20 Apr 2022.

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