LymphomaPhase 1NCT02836834
Safety, Tolerability, Pharmacokinetics & Pharmacodynamics of an Anti-PD-1 mAb for Patients With Advanced Solid Tumors
A Phase 1 study testing JS001 in people with Lymphoma and Lung Cancer, run by Shanghai Junshi Bioscience Co., Ltd. at 1 site in China.
Trial summary
The primary objective is to assess the safety and tolerability of JS-001 in subjects with various advanced or recurrent malignancies, including solid tumors and lymphomas, and to evaluate its preliminary efficacy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lymphoma, Lung Cancer
- What is being tested?
- JS001
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteChina
- Study dates
- Aug 2016to Dec 2020
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing to sign Informed Consent;
- Re-entry into the study is allowed with a second informed consent;
- Willing to provide blood sample for biomarker analysis(mandatory). The tissue sample is optional;
- A diagnosis of an advanced malignant tumor confirmed by histology or cytology;
- No standard of care for the patient;
- At least 1 measurable lesion;
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- Aged 18-65 years;
- Anticipated life expectancy of at least 3 months;
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;
- i) At least 4 weeks elapsed since receiving systemic chemotherapy, at least 6 weeks since receiving mitomycin or nitrosoureas, and at least 2 weeks since receiving a tyrosine kinase inhibitor;
- At least 4 weeks elapsed since receiving definite radiotherapy, and at least 2 weeks since receiving palliative radiotherapy;
- At least 2 weeks since the last dose of systemic steroid therapy (>10 mg/day prednisone or equivalent);
- At least 4 weeks since receiving anti-cancer biotherapy;
- Recovered from previous treatment related adverse reaction;
- willing to use an acceptable contraceptive method;
- A negative pregnancy test for female subjects of childbearing potential;
Who cannot join
- Active central nervous system (CNS) metastases and/or carcinomatous meningitis;
- Known history of another primary solid tumor, unless the participant has undergone potentially curative therapy with no evidence of that disease for 2 years, or underwent successful definitive resection of basal or squamous cell carcinoma of the skin, or in situ cervical cancer;
- Active, known or suspected autoimmune disease;
- Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2,or anti-cytotoxic T-lymphocyte antigen 4 (CTLA-4) blocking antibodies;
- Significant medical disease;
- Active infection;
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- Active tuberculosis or history of tuberculosis with one year;
- Infection of Human immunodeficiency virus (HIV);
- A complication requiring immune-suppression;
- Received a live vaccine within 4 weeks prior to first dose of study drug
- pleural or abdominal effusion with symptoms;
- Drug or alcohol abuse (for subjects in the pharmacokinetic cohorts) ;
- evidence of interstitial lung disease;
- Active hepatitis B or C, or with significant risk of hepatitis reactivation;
- Known immediate or delayed hypersensitivity reaction or idiosyncrasy to monoclonal antibodies or drugs chemically related to the study drug. History of serious hypersensitivity reaction or serious hepatotoxicity related to any drug.
Trial locations and contacts
1 site in 1 country.
China1 site
Cancer Hospital Chinese Academy of Medical Science
Beijing, Beijing Municipality, 100021
About this study
Official title: A Phase I Study of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of Recombinant Humanized Anti-PD-1 Monoclonal Antibody for Injection in Patients With Advanced Solid Tumors
The primary objective is to assess the safety and tolerability of JS-001 in subjects with various advanced or recurrent malignancies, including solid tumors and lymphomas, and to evaluate its preliminary efficacy.
The secondary objectives are to: 1) characterize the single-dose and multi-dose pharmacokinetic (PK) profile of JS-001, 2) characterize the immunogenicity of JS-001; 3) assess the dose-efficacy relationship of JS-001 single agent, and 4) preliminarily evaluate biomarkers associated with the efficacy of JS-001.
The exploratory objectives include to evaluate the consistency between biomarker detection results of archived tissue and fresh frozen tissue, and to assess the consistency of response using various response criteria (such as irRC, WHO, RECIST and irRECIST).
Read the detailed description
OVERVIEW This is a Phase 1, open-label, dose-escalation study of JS-001, a humanized monoclonal IgG4 antibody targeting the Programmed Death -1 (PD-1). It is estimated that 18-36 subjects with advanced or recurrent solid tumors or lymphomas will be enrolled in the dose-escalation study.
A 3+3 design will be utilized for this Phase 1 study. Three dose levels are planned and include: 1, 3, 10 mg/kg/dose. Each of the 3 dose levels will use 2 dose schedules: single dose, and repeated doses every 2 weeks. Subjects will be assigned to a dose schedule in the order of study entry.
The study will be the traditional 3 + 3 design with 3 or 6 subjects treated at this dose level and at all subsequent dose levels depending upon the incidence of DLTs. If no DLTs occur in a cohort of 3 subjects, a new cohort of 3 subjects will be treated at the next higher dose level. If 1 of 3 subjects in a cohort experiences a DLT, that cohort will be expanded to 6 subjects. If only 1 of the 6 subjects has a DLT, then the next cohort of 3 subjects will be treated at the next higher dose level. If 2 or more DLTs occur within a cohort, then that dose level will be above the MTD (the highest dose where no more than 1 of 6 subjects has experienced a DLT), and the previous lower (tolerated) dose level will be considered the MTD.
A DLT is defined as a Grade 3 drug-related adverse event occurring within 28 days after previous dose (excluding tumor flare defined as local pain, irritation, or rash localized at sites of known or suspected tumor or a transient Grade 3 infusion adverse event) using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 in a single dose cohort.
Tumor response will be evaluated using immune-related response criteria (irRC), , Response Evaluation Criteria in Solid Tumors (RECIST 1.1), , and International Workshop to Standardize Response Criteria for non-Hodgkin's Lymphomas (for lymphomas only).
In the absence of confirmed disease progression and intolerable toxicities, subjects in the single dose cohorts and multiple dose cohorts will be allowed to continue JS-001 administration with the consent of the subject.
If there is an effective case in a given dose level and the safety is good (There is no more than Grade 2 adverse event (not included Grade 2), 6-14 subjects with soft tissue sarcoma will be enrolled in the dose level as expanded cohort. The subjects of expanded cohort will use repeated doses every 2 weeks like multiple dose cohorts to further evaluate safety and efficacy of JS-001 with soft tissue sarcoma. At the same time, 9-12 subjects with hodgkin lymphoma will be enrolled in 3 mg/kg/dose level as expanded cohort. The subjects of expanded cohort will use repeated doses every 2 weeks like multiple dose cohorts to further evaluate safety and efficacy of JS-001 with hodgkin lymphoma.
DOSAGE AND ADMINISTRATION JS-001 will be administered as a 60-minute i.v. infusion. Cohorts will include escalating dose levels of 1, 3, 10mg/kg/dose.
SAFETY EVALUATIONS Assessment of safety will be determined by vital sign measurements, clinical laboratory tests, Eastern Cooperative Oncology Group (ECOG) performance status evaluations, diagnostic imaging, physical examinations, electrocardiograms, and the incidence and severity of adverse events.
Safety will also include evaluations of immune safety and immunogenicity. Particular attention will be given to adverse events that may follow enhanced T-cell activation such as dermatitis and colitis, uveitis, or other immune-related adverse events (irAEs).
An irAE is a clinically significant adverse event of any organ that is associated with drug exposure, of unknown etiology, and is consistent with an immune-mediated mechanism.
EFFICACY EVALUATIONS The primary efficacy endpoint is the best response rate (RR). Duration of response, progression-free survival, time to progression, and overall survival will also be analyzed.
PHARMACOKINETIC EVALUATIONS Pharmacokinetic parameters include AUC, Cmax, tmax, and t½, etc. STATISTICAL METHODS The sample size for this study is not determined from power analysis. It is based on the 3+3 design for dose escalation and safety evaluation requirements.
Descriptive statistics will include: mean, standard deviation, median, and minimum and maximum values for continuous variables; frequencies and percentages for categorical variables.
The efficacy parameters will be summarized using descriptive statistics. All safety and pharmacokinetic parameters will be summarized using descriptive statistics.
- Conditions
- Lymphoma, Lung Cancer
- Being tested
- JS001
- Keywords
- immunotherapy, check point inhibitor, PD-1 antibody, solid tumor, lymphoma, phase 1 trial
- Medical subject headings
- Lymphoma, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JS001Biological
Also called toripalimab, TAB001
Dose escalation study evaluating three dose levels (1, 3 and 10 mg/kg) of JS-001.Each of the 3 dose levels will use 2 dose schedules: single dose, and repeated doses every 2 weeks. Subjects will be assigned to a dose schedule in the order of study entry.
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation Cohort | Experimental | JS001 Receives: Biological: JS001 |
| Expanded cohort 1 | Experimental | The subjects of expanded cohort 1 will use repeated doses every 2 weeks like multiple dose cohorts Receives: Biological: JS001 |
| Expanded cohort 2 | Experimental | The subjects of expanded cohort 2 will use repeated doses every 2 weeks like multiple dose cohorts Receives: Biological: JS001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: 154 days
Secondary outcomes (1)
correlation analysis of PD-L1 expression of tumor and ORR
Measured: 154 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2016 (estimated)
- Study startAug 2016
- Primary completionSep 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Junshi Bioscience Co., Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yuankai Shi, PhD.MD, Principal investigator, Cancer Hospital Chinese Academy of Medical Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02836834
- Sponsor's protocol ID
- Junshi-JS001-YKZL-I
- Status last verified
- Oct 2019
- First submitted
- 13 Jul 2016
- Last updated
- 22 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Yang J, Dong L, Yang S, Han X, Han Y, Jiang S, Yao J, Zhang Z, Zhang S, Liu P, Qin Y, Wu H, Feng H, Yao S, Sun Y, Song H, Shi Y. Safety and clinical efficacy of toripalimab, a PD-1 mAb, in patients with advanced or recurrent malignancies in a phase I study. Eur J Cancer. 2020 May;130:182-192. doi: 10.1016/j.ejca.2020.01.028. Epub 2020 Mar 27.
PubMed 32224416
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of Recombinant Humanized Anti-PD-1 Monoclonal Antibody for Injection in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT02836834
- Acronym / sponsor ID
- Junshi-JS001-YKZL-I
- Conditions
- Lymphoma, Lung Cancer
- Keywords
- immunotherapy, check point inhibitor, PD-1 antibody, solid tumor, lymphoma, phase 1 trial
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Shanghai Junshi Bioscience Co., Ltd.University, hospital or other
- Study start
- Aug 2016 (actual)
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 19 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective is to assess the safety and tolerability of JS-001 in subjects with various advanced or recurrent malignancies, including solid tumors and lymphomas, and to evaluate its preliminary efficacy.
The secondary objectives are to: 1) characterize the single-dose and multi-dose pharmacokinetic (PK) profile of JS-001, 2) characterize the immunogenicity of JS-001; 3) assess the dose-efficacy relationship of JS-001 single agent, and 4) preliminarily evaluate biomarkers associated with the efficacy of JS-001.
The exploratory objectives include to evaluate the consistency between biomarker detection results of archived tissue and fresh frozen tissue, and to assess the consistency of response using various response criteria (such as irRC, WHO, RECIST and irRECIST).
Detailed description
OVERVIEW This is a Phase 1, open-label, dose-escalation study of JS-001, a humanized monoclonal IgG4 antibody targeting the Programmed Death -1 (PD-1). It is estimated that 18-36 subjects with advanced or recurrent solid tumors or lymphomas will be enrolled in the dose-escalation study.
A 3+3 design will be utilized for this Phase 1 study. Three dose levels are planned and include: 1, 3, 10 mg/kg/dose. Each of the 3 dose levels will use 2 dose schedules: single dose, and repeated doses every 2 weeks. Subjects will be assigned to a dose schedule in the order of study entry.
The study will be the traditional 3 + 3 design with 3 or 6 subjects treated at this dose level and at all subsequent dose levels depending upon the incidence of DLTs. If no DLTs occur in a cohort of 3 subjects, a new cohort of 3 subjects will be treated at the next higher dose level. If 1 of 3 subjects in a cohort experiences a DLT, that cohort will be expanded to 6 subjects. If only 1 of the 6 subjects has a DLT, then the next cohort of 3 subjects will be treated at the next higher dose level. If 2 or more DLTs occur within a cohort, then that dose level will be above the MTD (the highest dose where no more than 1 of 6 subjects has experienced a DLT), and the previous lower (tolerated) dose level will be considered the MTD.
A DLT is defined as a Grade 3 drug-related adverse event occurring within 28 days after previous dose (excluding tumor flare defined as local pain, irritation, or rash localized at sites of known or suspected tumor or a transient Grade 3 infusion adverse event) using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 in a single dose cohort.
Tumor response will be evaluated using immune-related response criteria (irRC), , Response Evaluation Criteria in Solid Tumors (RECIST 1.1), , and International Workshop to Standardize Response Criteria for non-Hodgkin's Lymphomas (for lymphomas only).
In the absence of confirmed disease progression and intolerable toxicities, subjects in the single dose cohorts and multiple dose cohorts will be allowed to continue JS-001 administration with the consent of the subject.
If there is an effective case in a given dose level and the safety is good (There is no more than Grade 2 adverse event (not included Grade 2), 6-14 subjects with soft tissue sarcoma will be enrolled in the dose level as expanded cohort. The subjects of expanded cohort will use repeated doses every 2 weeks like multiple dose cohorts to further evaluate safety and efficacy of JS-001 with soft tissue sarcoma. At the same time, 9-12 subjects with hodgkin lymphoma will be enrolled in 3 mg/kg/dose level as expanded cohort. The subjects of expanded cohort will use repeated doses every 2 weeks like multiple dose cohorts to further evaluate safety and efficacy of JS-001 with hodgkin lymphoma.
DOSAGE AND ADMINISTRATION JS-001 will be administered as a 60-minute i.v. infusion. Cohorts will include escalating dose levels of 1, 3, 10mg/kg/dose.
SAFETY EVALUATIONS Assessment of safety will be determined by vital sign measurements, clinical laboratory tests, Eastern Cooperative Oncology Group (ECOG) performance status evaluations, diagnostic imaging, physical examinations, electrocardiograms, and the incidence and severity of adverse events.
Safety will also include evaluations of immune safety and immunogenicity. Particular attention will be given to adverse events that may follow enhanced T-cell activation such as dermatitis and colitis, uveitis, or other immune-related adverse events (irAEs).
An irAE is a clinically significant adverse event of any organ that is associated with drug exposure, of unknown etiology, and is consistent with an immune-mediated mechanism.
EFFICACY EVALUATIONS The primary efficacy endpoint is the best response rate (RR). Duration of response, progression-free survival, time to progression, and overall survival will also be analyzed.
PHARMACOKINETIC EVALUATIONS Pharmacokinetic parameters include AUC, Cmax, tmax, and t½, etc. STATISTICAL METHODS The sample size for this study is not determined from power analysis. It is based on the 3+3 design for dose escalation and safety evaluation requirements.
Descriptive statistics will include: mean, standard deviation, median, and minimum and maximum values for continuous variables; frequencies and percentages for categorical variables.
The efficacy parameters will be summarized using descriptive statistics. All safety and pharmacokinetic parameters will be summarized using descriptive statistics.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation Cohort | Experimental | Biological: JS001JS001 |
| Expanded cohort 1 | Experimental | Biological: JS001The subjects of expanded cohort 1 will use repeated doses every 2 weeks like multiple dose cohorts |
| Expanded cohort 2 | Experimental | Biological: JS001The subjects of expanded cohort 2 will use repeated doses every 2 weeks like multiple dose cohorts |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Willing to sign Informed Consent;
- Re-entry into the study is allowed with a second informed consent;
- Willing to provide blood sample for biomarker analysis(mandatory). The tissue sample is optional;
- A diagnosis of an advanced malignant tumor confirmed by histology or cytology;
- No standard of care for the patient;
Key exclusion criteria (15 listed)
- Active central nervous system (CNS) metastases and/or carcinomatous meningitis;
- Known history of another primary solid tumor, unless the participant has undergone potentially curative therapy with no evidence of that disease for 2 years, or underwent successful definitive resection of basal or squamous cell carcinoma of the skin, or in situ cervical cancer;
- Active, known or suspected autoimmune disease;
- Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2,or anti-cytotoxic T-lymphocyte antigen 4 (CTLA-4) blocking antibodies;
- Significant medical disease;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JS001Also: toripalimab, TAB001Dose escalation study evaluating three dose levels (1, 3 and 10 mg/kg) of JS-001.Each of the 3 dose levels will use 2 dose schedules: single dose, and repeated doses every 2 weeks. Subjects will be assigned to a dose schedule in the order of study entry. | Biological | Dose Escalation Cohort, Expanded cohort 1, Expanded cohort 2 |
Primary outcome
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 154 days
1 secondary outcome
correlation analysis of PD-L1 expression of tumor and ORR
Time frame: 154 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2019.
- Derived from this study: PubMed 32224416Yang J, Dong L, Yang S, Han X, Han Y, Jiang S, Yao J, Zhang Z, Zhang S, Liu P, Qin Y, Wu H, Feng H, Yao S, Sun Y, Song H, Shi Y. Safety and clinical efficacy of toripalimab, a PD-1 mAb, in patients with advanced or recurrent malignancies in a phase I study. Eur J Cancer. 2020 May;130:182-192. doi: 10.1016/j.ejca.2020.01.028. Epub 2020 Mar 27.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuankai Shi, PhD.MD principal investigator
Cancer Hospital Chinese Academy of Medical Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing JS001 in people with Lymphoma and Lung Cancer, 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 16 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: status not confirmed, as of the sponsor's last update on 22 Oct 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?
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 v4.0 (time frame: 154 days). 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 NCT02836834, 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 22 Oct 2019.