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Neuroendocrine TumorsPhase 1NCT03167853

Study of JS001 in Patients With Advanced Neuroendocrine Tumors

A Phase 1 study testing humanized anti-PD-1 monoclonal antibody in people with Neuroendocrine Tumors, run by Peking University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a multi-center, open-label, phase Ib study evaluating safety and efficacy of the humanized anti-PD-1 antibody JS001, as a monotherapy in patients with neuroendocrine tumors who have failed in previous systemic treatment. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Neuroendocrine Tumors
What is being tested?
humanized anti-PD-1 monoclonal antibody
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteChina
Study dates
6 Apr 2017to 11 May 2019
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Must have read, understood, and provided written informed consent voluntarily. Willing to adhere to the study visit schedule and the prohibitions and restrictions specified in this protocol.
  • Male and Female aged 18 and older are eligible;
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
  • Histologic diagnosis of locally advanced or metastatic nonfunctional neuroendocrine tumors, including well-differentiated neuroendocrine tumors and pooly-differentiated neuroendocrine carcinoma;
  • Ki-67 index ≥10%;
  • Unresectable;
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  • Radiographic evidence of disease rogression by RECIST criteria on or after last anti-cancer therapy within 6 months;
  • Prior treatment meeting the following criteria:
  • Patients with pooly-differentiated neuroendocrine carcinomas must have received platinum based lineds of chemotherapy;
  • Patients with well-differentiated neuroendocrine tumors must have received at least one systemic treatment, including somatostatin analogs, mTOR inhibitors, anti-angiogentic agents and chemotherapy;
  • Providing with tumor specimen (for testing the expression of PD L1 and the infiltrating lymphocytes);
  • Predicted survival >=3 months;
  • At least 1 measurable lesion (only 1 measurable lymph node lesion is excluded) (routine CT scan >=20mm, spiral CT scan >=10mm, no prior radiation to measurable lesions);
  • Screening laboratory values must meet the following criteria (within past 14 days): hemoglobin ≥ 9.0 g/dL; neutrophils ≥ 1500 cells/ μL; platelets ≥ 100 x 10^3/ μL; total bilirubin ≤ 1.5 x upper limit of normal (ULN); aspartic transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 x ULN without, and ≤ 5 x ULN with hepatic metastasis; serum creatinine ≤1╳ULN, creatinine clearance >50ml/min (CockcroftGault equation) PT/INR, aPTT≤1.5 x ULN;
  • Without systemic steroids within past 4 weeks;
  • Brain or meningeal metastases must be disposed with surgery or radiation, and be stable clinically for at least 3 months (prior systemic steroids was allowed, but concurrent administration of systemic steroids with the study drug is excluded);
  • Males or female of childbearing potential must: agree to use using a reliable form of contraception (eg, oral contraceptives, intrauterine device, control sex desire, double barrier method of condom and spermicidal) during the treatment period and for at least 12 months after the last dose of study drug.

Who cannot join

  • Prior treatment with antiPD1/PDL1/PDL2 antibody;
  • Hypersensitivity to recombinant humanized antiPD1 monoclonal Ab or its components;
  • Prior treatment with mAb within past 4 weeks;
  • Prior antitumor therapy (including corticosteroids and immunotherapy) or participation in other clinical trials within past 4 weeks, or have not recovered from toxicities since the last treatment;
  • Pregnant or nursing;
  • Positive tests for HIV, HCV, HBsAg or HBcAb with positive test for HBV DNA (>500IU/ml);
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  • History with tuberculosis;
  • Patients with any active autoimmune disease or a documented history of autoimmune disease, or history of syndrome that required systemic steroids or immunosuppressive medications, such as hypophysitis, pneumonia, colitis, hepatitis, nephritis, hyperthyroidism or hypothyroidism;
  • Severe, uncontrolled medical condition that would affect patients' compliance or obscure the interpretation of toxicity determination or adverse events, including active severe infection, uncontrolled diabetes, angiocardiopathy (heart failure > class II NYHA, heart block >II grade, myocardial infarction, unstable arrhythmia or unstable angina within past 6 months, cerebral infarction within past 3 months) or pulmonary disease ( interstitial pneumonia, obstructive pulmonary disease or symptomatic bronchospasm);
  • Evidence with active CNS disease;
  • Meningeal carcinomatosis;
  • Prior treatment with bone marrow stimulating factors，such as CSF (colony stimulating factor), EPO (erythropoietin), within past 2 weeks;
  • Prior live vaccine therapy within past 4 weeks;
  • Prior major surgery within past 4 weeks (diagnostic surgery excluded);
  • Psychiatric medicines abuse without withdrawal, or history of psychiatric illness;
  • Prior malignancy active within the previous 5 years except for locally curable cancers that have been apparently cured, such as basal cell skin cancer or carcinoma in situ of the cervix;
  • Underlying medical condition that, in the Investigator's opinion, would increase the risks of study drug administration or obscure the interpretation of toxicity determination or adverse events.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

Other trials in China

About this study

Official title: Phase Ib Study of Safety and Efficacy of Recombinant Humanized Anti-PD-1 Monoclonal Antibody for Patients With Advanced Neuroendocrine Tumors Following Failure of First-Line

This is a multi-center, open-label, phase Ib study evaluating safety and efficacy of the humanized anti-PD-1 antibody JS001, as a monotherapy in patients with neuroendocrine tumors who have failed in previous systemic treatment. 40 patients are enrolled and injected with the humanized anti-PD-1 antibody 3mg/mg every 2 weeks until disease progresses or unacceptable toxicity.

Being tested
humanized anti-PD-1 monoclonal antibody
Medical subject headings
Neuroendocrine Tumors

What participants receive

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

  • humanized anti-PD-1 monoclonal antibodyBiological

    Also called JS001

    humanized anti-PD-1 monoclonal antibody(JS001) is a programmed death-1 (PD-1) immune checkpoint inhibitor antibody, which selectively interferes with th combination of PD-1 with its ligands, PD-L1 and PD-L2, resulting in the activitation of lymphocytes and elimination of malignancy theoretically.

Study groups in NCT03167853
Study groupRoleWhat they receive
humanized anti-PD-1 monoclonal antibodyExperimentalhumanized anti-PD-1 monoclonal antibody is to be injected intravenously 3mg/kg per 2 weeks until disease progresses or unacceptable tolerability occurs.
Receives: Biological: humanized anti-PD-1 monoclonal antibody

What is being measured

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

  1. Overall response rate (ORR)

    CT/MRI will be performed every 2 cycles of treatment by RECIST 1.1(each cycle is 21 days))

    Measured: From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months

Secondary outcomes (8)

  1. Duration of response (DOR)

    Duration of Response by irRC and RECIST 1.1

    Measured: baseline, every 8 weeks up to 1 year after last patient first treatment

  2. Progression-free survival

    Progression-free survival is defined as the time from the date of first dose to the date of the first documented radiological progression or death due to any cause

    Measured: baseline, every 8 weeks up to 1 year after last patient first treatment

  3. Overall survival

    Overall survival is defined as the time from date of start of treatment to date of death due to any cause

    Measured: Every 3 months after last visit up to 2 year after last patient first treatment

  4. Immune Response Criteria by irRECIST (immune response duration of response)

    Immune Response Criteria by irRECIST and as per BIRC (immune response duration of response)

    Measured: baseline, every 8 weeks up to 1 year after last patient first treatment

  5. Immune Response Criteria by irRECIST (immune response overall response rate)

    Immune Response Criteria by irRECIST and as per BIRC (immune response overall response rate)

    Measured: baseline, every 8 weeks up to 1 year after last patient first treatment

  6. Biochemical response

    Changes from baseline in chromogranin-A

    Measured: baseline, 6th week, 16th week

  7. Correlation analysis of PD-L1/CD8 expression of tumor and ORR

    Changes from baseline in PD-L1/CD8 expression

    Measured: 3 years

  8. Correlation analysis of circulating tumor cells (CTC) and ORR

    Changes from baseline of circulating tumor cells (CTC)

    Measured: baseline, 8th week

Timeline

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

  1. First posted30 May 2017
  2. Study start6 Apr 2017
  3. Primary completion11 Dec 2018
  4. Study completion11 May 2019

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03167853
Sponsor's protocol ID
HMO-JS001-Ib-NEC-02
Status last verified
Jun 2019
First submitted
10 May 2017
Last updated
21 Jun 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lu M, Zhang P, Zhang Y, Li Z, Gong J, Li J, Li J, Li Y, Zhang X, Lu Z, Wang X, Zhou J, Peng Z, Wang W, Feng H, Wu H, Yao S, Shen L. Efficacy, Safety, and Biomarkers of Toripalimab in Patients with Recurrent or Metastatic Neuroendocrine Neoplasms: A Multiple-Center Phase Ib Trial. Clin Cancer Res. 2020 May 15;26(10):2337-2345. doi: 10.1158/1078-0432.CCR-19-4000. Epub 2020 Feb 21.

    PubMed 32086343

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing humanized anti-PD-1 monoclonal antibody in people with Neuroendocrine Tumors, run by Peking 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 17 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: finished, as of the sponsor's last update on 21 Jun 2019. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Overall response rate (ORR) (time frame: From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months). 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 NCT03167853, which also lists 1 linked publication.

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 21 Jun 2019.

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