AzTrials
AzTrials

NSCLCPhase 1NCT03301688

The Pharmacokinetics and Safety of Single-dose and Parallel Comparisons in Patients With NSCLC Treated With JS001

A Phase 1 study testing Toripalimab in people with NSCLC, run by Shanghai Junshi Bioscience Co., Ltd. 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
Search all trials

Trial summary

This study was designed to evaluate the similarity of single-dose and parallel comparisons of recombinant humanized anti-PD-1 monoclonal antibody injections before and after process changes. It is designed to be a single-center, open and parallel controlled phase I study. Patients with advanced NSCLC will be enrolled. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
NSCLC
What is being tested?
Toripalimab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
1 siteChina
Study dates
18 Sep 2017to 15 Dec 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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male and Female aged 18 to 70 years are eligible;
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
  • Histologic diagnosis of NSCLS. Have failed at least 1 prior routine regimen for metastatic disease, or failed to tolerate the toxicity, or lack of any routine regimens.
  • Providing with tumor specimen (for testing the expression of PD -L1 and the infiltrating lymphocytes);
  • 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) Predicted survival >=6 months;
  • Brain or meningeal metastases must be disposed with surgery or radiation, and be stable clinically for at least 8 weeks (prior systemic steroids was allowed, but concurrent administration of systemic steroids with the study drug is excluded).
Show all 11Show fewer
  • 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 (Cockcroft-Gault equation)
  • Without systemic steroids within past 4 weeks
  • 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.
  • 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.

Who cannot join

  • Hypersensitivity to recombinant humanized anti-PD-1 monoclonal Ab or its components.
  • Prior treatment with mAb within past 3 months (locally administration excluded)
  • 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
  • Abnormal Blood coagulation
  • Positive tests for HIV, HCV, HBsAg or HBcAb with positive test for HBV DNA (>500IU/ml)
Show all 15Show fewer
  • History with pulmonary 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).
  • Prior treatment with bone marrow stimulating factors，such as CSF (colony stimulating factor), EPO (erythropoietin), within past 1 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

  • Cancer Hospital Chinese Academy of Medical Science

    Beijing, Beijing Municipality, 100021

Other trials in China

About this study

Official title: A Similar Phase I Study on the Pharmacokinetics and Safety of Single-dose and Parallel Comparisons in Patients With Advanced NSCLC Treated With Recombinant Humanized Anti-PD-1 Monoclonal Antibody (JS001) Before and After Process Change

This study was designed to evaluate the similarity of single-dose and parallel comparisons of recombinant humanized anti-PD-1 monoclonal antibody injections before and after process changes. It is designed to be a single-center, open and parallel controlled phase I study. Patients with advanced NSCLC will be enrolled.

After determining that the patient is qualified, the patient will be assigned to a batch of drug use in the order in which they are selected. The dosage of drug was set at 3 mg / kg. Planned to recruit subjects each 12 patients (24 cases) to participate in this study, taking into account a 20% dropout rate, so that the total of 15 patients (30 patients) subjects in each group in this study.

This study was divided into study phase (single-dose period) and follow-up stage (multiple-dose period).Each subject first conducted a single dose safety and pharmacokinetics (PK) study.If the subject did not develop adverse events that had significant clinical significance as suggested by the investigators within 28 days of the single dose and continued reorganization of the humanized anti-PD-1 monoclonal antibody injection to benefit the patient , and with the agreement of subjects, the subject will enter the follow-up phase (multiple-dose period). The same dose of recombinant humanized anti-PD-1 monoclonal antibody injection was administered once every 2 weeks and 4 consecutive cycles of treatment for one cycle of continuous period.Until the patient has developed tumor progression or an untolerated toxic side effect, the patient voluntarily exits the study or believes that the situation is not suitable for continuing treatment. There are follow-up of 90 days after treatment.

Conditions
NSCLC
Being tested
Toripalimab
Keywords
PD-1 antibody, phase 1 trial

What participants receive

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

  • ToripalimabBiological

    Also called JS001, TAB001

    To compare the different drug batch number with different process

Study groups in NCT03301688
Study groupRoleWhat they receive
A group (JS001 20161002)ExperimentalThe subjects of A group will use 3 mg/kg doses every 2 weeks.Drug batch number is 20161002.
Receives: Biological: Toripalimab
B group (JS001 20161108)ExperimentalThe subjects of B group will use 3 mg/kg doses every 2 weeks.Drug batch number is 20161108.
Receives: Biological: Toripalimab

What is being measured

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

  1. Area Under the Curve (AUC) after single dose injection of Anti-PD-1 mAb

    Measured: 6 months

Secondary outcomes (15)

  1. Objective response rate (ORR)

    Objective Response Rate (ORR) by irRC and RECIST 1.1

    Measured: 6 months

  2. Duration of response (DOR)

    Duration of response (DOR) by irRC and RECIST 1.1

    Measured: 6 months

  3. Disease control rate (DCR)

    Disease control rate (DCR) by irRC and RECIST 1.1

    Measured: 6 months

  4. Progression Free Survival (PFS)

    Progression Free Survival (PFS) by irRC and RECIST 1.1

    Measured: 6 months

  5. Overall Survival (OS)

    Overall Survival (OS) by irRC and RECIST 1.1

    Measured: 6 months

  6. Time to response (TTR)

    Time to response (TTR) by irRC and RECIST 1.1

    Measured: 6 months

  7. Maximum Plasma Concentration (Cmax) after single dose injection of Anti-PD-1 Monoclonal Antibody (mAb)

    Measured: 6 months

  8. Peak Time (Tmax) after single dose injection of Anti-PD-1 mAb

    Measured: 6 months

  9. t1/2 after single dose injection of Recombinant Humanized Anti-PD-1 mAb

    Measured: 6 months

  10. Plasma clearance (CL) after single dose injection of Anti-PD-1 mAb

    Measured: 6 months

  11. Apparent volume of distribution (V) after single dose injection of Anti-PD-1 mAb

    Measured: 6 months

  12. Minimum Plasma Concentration (Cmin) of steady state after multiple dose injection of Anti-PD-1 mAb

    Measured: 6 months

  13. Average Plasma Concentration (Cav) of steady state after multiple dose injection of Anti-PD-1 mAb

    Measured: 6 months

  14. degree of fluctuation (DF) of steady state after multiple dose injection of Anti-PD-1 mAb

    Measured: 6 months

  15. Apparent volume of distribution of steady state (Vss) after multiple dose injection of Anti-PD-1 mAb

    Measured: 6 months

Timeline

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

  1. First posted4 Oct 2017
  2. Study start18 Sep 2017
  3. Primary completion15 Sep 2018
  4. Study completion15 Dec 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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03301688
Sponsor's protocol ID
Junshi-JS001-012
Status last verified
Sep 2020
First submitted
29 Sep 2017
Last updated
30 Sep 2020
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 Toripalimab in people with NSCLC, run by Shanghai Junshi Bioscience 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 11 inclusion and 15 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 30 Sep 2020. 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?

Area Under the Curve (AUC) after single dose injection of Anti-PD-1 mAb (time frame: 6 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 NCT03301688.

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 30 Sep 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in