Solid TumorPhase 1NCT02742935
A Study to Evaluate the Safety and Tolerability of Using SHR-1210 by Advanced Solid Tumor Subjects
A Phase 1 study testing camrelizumab in people with Solid Tumor and Breast Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
This is an open-label, non-randomized, dose escalation phase I trial to evaluate safety and tolerability of SHR-1210 in patients with advanced solid tumors. The primary objective is to assess safety and tolerability of SHR-1210 and identify recommended phase II doses of SHR-1210 in patients with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Solid Tumor, Breast Cancer, Gastrointestinal Cancer
- What is being tested?
- camrelizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteChina
- Study dates
- 27 Apr 2016to 6 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female 18-65 years of age;
- Histologically confirmed solid tumor ;
- Documented as advanced disease(unresectable or metastatic disease), failure to standard therapies or lack of standard therapy;
- ECOG performance status of 0 or 1;
- Life expectancy ≥ 12 weeks.;
- Ideally, subjects enrolled have measurable lesion(s) according to RECIST v1.1/mRECIST(liver cancer);
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- Adequate laboratory parameters during the screening period as evidenced by the following:
- Absolute neutrophil count ≥ 1.5 × 109/L ;
- Platelets ≥ 100 × 109/L;
- Hemoglobin ≥ 9.0 g/dL;
- Albumin (ALB) levels ≥ 2.8 g/dL
- Total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN), ALT and AST ≤ 1.5
- ULN; for subjects with liver metastases, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 5 × ULN;
- Creatinine clearance≥50 mL/min;
- Female and male who have reproductive potential must be willing and able to employ a highly effective method of birth control/contraception to prevent pregnancy while on treatment and for at least 3 months after receiving the last dose of study treatment. Women of childbearing potential with pregnancy test negative within 7days before entering the group and not in in lactation;
- Able to understand and sign an informed consent form (ICF).
Who cannot join
- Subjects with any active autoimmune disease or history of autoimmune disease, including but not limited to the following: interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism and hypothyroidism, except for subjects with vitiligo or resolved childhood asthma/atopy, asthma that requires intermittent use of bronchodilators can not be included;
- Concurrent medical condition requiring the use of immunosuppressive medications, or immunosuppressive doses of systemic or absorbable topical corticosteroids. Doses > 10 mg/day prednisone or equivalent are prohibited within 2 weeks before entering the group;
- 3 History of organ transplantation (except corneal transplantation);
- 4. Known history of hypersensitivity to macromolecular protein preparation or any components of the SHR-1210 formulation;
- 5 History or concurrent with other malignant disease, except completely cured basal cell skin cancers and carcinoma in situs of cervix;
- 6. Presence of symptomatic central nervous system (CNS) metastases (indicated cerebral edema, steroid requirement, or progressive disease), Subjects with brain or meningeal metastases that were previously treated must be clinically stable (MRI) for at least 2 months, and have discontinued systemic steroids (> 10 mg/day prednisone or equivalent) for at least 2 weeks before study drug administration;
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- 7. Uncontrolled clinically significant heart disease, including but not limited to the following: (1) >2 NYHA 2 congestive heart failure; (2) unstable angina, (3) myocardial infarction within the past 1 year; (4) clinically significant supraventricular arrhythmia or ventricular arrhythmia requirement for treatment or intervention;
- 8. Prior radiotherapy, systemic chemotherapy (< 6 weeks if chemotherapy including nitrosoureas or mitomycin), hormone therapy, surgery or target therapy within 4 weeks before the study drug administration, or any unresolved AEs > CTC-AE Grade 1;
- 9. Active infection or an unexplained fever > 38.5°C during screening or before the first scheduled day of dosing (subjects with tumor fever may be enrolled at the discretion of the investigator);
- 10. History of immunodeficiency (HIV) or active hepatitis;
- 11. Participation in a clinical study or less than 1 month from the last dose of investigational drug to sign ICF;
- 12. May require for other systemic anti-tumor therapy during the study period;
- 13. History of PD-1/PD-L1 therapy;
- 14. History of psychotropic substance abuse, alcoholism or drug abuse;
- 15. Other factors that may lead to the termination of the participation in the study at the discretion of the investigators.
Trial locations and contacts
1 site in 1 country.
China1 site
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality
About this study
Official title: A Phase 1 Clinical Study on the Safety and Tolerability of PD-1 Antibody SHR-1210 in Patients With Advanced Solid Tumors
This is an open-label, non-randomized, dose escalation phase I trial to evaluate safety and tolerability of SHR-1210 in patients with advanced solid tumors. The primary objective is to assess safety and tolerability of SHR-1210 and identify recommended phase II doses of SHR-1210 in patients with advanced solid tumors.
Read the detailed description
This is an open-label, nonrandomized, dose-escalation Phase 1 study to evaluate safety and tolerability of SHR-1210 in subjects with advanced Solid Tumors who have failed current standard antitumor therapies.
The safety and tolerability of SHR-1210 will be assessed by ongoing reviews of clinical laboratory tests, Eastern Cooperative Oncology Group (ECOG) performance status, physical examination, electrocardiogram (ECG), and adverse events. Evaluations of immune safety will also be conducted (immune-related AEs, or labs of autoimmune sera, inflammatory events, and immunogenicity). Safety evaluations (both clinical and laboratory) are performed at baseline, before each study treatment, and throughout the study.
Efficacy will be assessed every 8 weeks. The study consists of 3 periods: screening (up to 14 days before the first dose), treatment, and follow-up (up to 90 days after the last dose of study treatment).
- Conditions
- Solid Tumor, Breast Cancer, Gastrointestinal Cancer
- Being tested
- camrelizumab
- Medical subject headings
- Breast Neoplasms, Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
camrelizumabBiological
Also called SHR-1210
A fully humanized anti-PD-1 monoclonal immunoglobulin (IgG4 subtype)
| Study group | Role | What they receive |
|---|---|---|
| camrelizumab | Experimental | camrelizumab (SHR-1210) injection, 60,200,400mg/dose, intravenous infusion over 30 minutes, every 2 weeks. Receives: Biological: camrelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
The severity of adverse events (AEs) determined as per NCI CTCAE V4.03.
safety endpoint
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2016 (estimated)
- Study start27 Apr 2016
- Primary completion6 May 2019
- Study completion6 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Qing Yang, Doctor, Study director, Jiangsu Hengrui Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02742935
- Sponsor's protocol ID
- SHR-1210-103
- Status last verified
- Feb 2023
- First submitted
- 14 Apr 2016
- Last updated
- 27 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Clinical Study on the Safety and Tolerability of PD-1 Antibody SHR-1210 in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT02742935
- Acronym / sponsor ID
- SHR-1210-103
- Conditions
- Solid Tumor, Breast Cancer, Gastrointestinal Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 27 Apr 2016 (actual)
- Primary completion
- 6 May 2019 (actual)
- Study completion
- 6 May 2019 (actual)
- First posted
- 19 Apr 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.
This is an open-label, non-randomized, dose escalation phase I trial to evaluate safety and tolerability of SHR-1210 in patients with advanced solid tumors. The primary objective is to assess safety and tolerability of SHR-1210 and identify recommended phase II doses of SHR-1210 in patients with advanced solid tumors.
Detailed description
This is an open-label, nonrandomized, dose-escalation Phase 1 study to evaluate safety and tolerability of SHR-1210 in subjects with advanced Solid Tumors who have failed current standard antitumor therapies.
The safety and tolerability of SHR-1210 will be assessed by ongoing reviews of clinical laboratory tests, Eastern Cooperative Oncology Group (ECOG) performance status, physical examination, electrocardiogram (ECG), and adverse events. Evaluations of immune safety will also be conducted (immune-related AEs, or labs of autoimmune sera, inflammatory events, and immunogenicity). Safety evaluations (both clinical and laboratory) are performed at baseline, before each study treatment, and throughout the study.
Efficacy will be assessed every 8 weeks. The study consists of 3 periods: screening (up to 14 days before the first dose), treatment, and follow-up (up to 90 days after the last dose of study treatment).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| camrelizumab | Experimental | Biological: camrelizumabcamrelizumab (SHR-1210) injection, 60,200,400mg/dose, intravenous infusion over 30 minutes, every 2 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Male or female 18-65 years of age;
- Histologically confirmed solid tumor ;
- Documented as advanced disease(unresectable or metastatic disease), failure to standard therapies or lack of standard therapy;
- ECOG performance status of 0 or 1;
- Life expectancy ≥ 12 weeks.;
Key exclusion criteria (15 listed)
- Subjects with any active autoimmune disease or history of autoimmune disease, including but not limited to the following: interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism and hypothyroidism, except for subjects with vitiligo or resolved childhood asthma/atopy, asthma that requires intermittent use of bronchodilators can not be included;
- Concurrent medical condition requiring the use of immunosuppressive medications, or immunosuppressive doses of systemic or absorbable topical corticosteroids. Doses > 10 mg/day prednisone or equivalent are prohibited within 2 weeks before entering the group;
- 3 History of organ transplantation (except corneal transplantation);
- 4. Known history of hypersensitivity to macromolecular protein preparation or any components of the SHR-1210 formulation;
- 5 History or concurrent with other malignant disease, except completely cured basal cell skin cancers and carcinoma in situs of cervix;
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 |
|---|---|---|
| camrelizumabAlso: SHR-1210A fully humanized anti-PD-1 monoclonal immunoglobulin (IgG4 subtype) | Biological | camrelizumab |
Primary outcome
The severity of adverse events (AEs) determined as per NCI CTCAE V4.03.
Time frame: 28 days
safety endpoint
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2023.
- 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.
Qing Yang, Doctor study director
Jiangsu Hengrui Pharmaceutical Co., Ltd.
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 camrelizumab in people with Solid Tumor and Breast Cancer, run by Jiangsu HengRui Medicine 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: finished, as of the sponsor's last update on 27 Feb 2023. 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?
The severity of adverse events (AEs) determined as per NCI CTCAE V4.03. (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Feb 2023.