Advanced Solid TumorPhase 1NCT03871855
A Study of SHR-1702 Alone or With Camrelizumab in Participants With Advanced Relapsed/Refractory Solid Tumors
A Phase 1 study testing SHR-1702 and Camrelizumab in people with Advanced Solid Tumor, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
The purpose of this study is to evaluate the safety of SHR-1702 monotherapy or in combination with Camrelizumab among advanced solid tumor subjects. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- SHR-1702 and Camrelizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteChina
- Study dates
- 28 Apr 2019to 21 Jun 2021
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed advanced relapsed/refractory solid tumors
- Must have a performance status of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG) scale
- Have an estimated life expectancy of 12 weeks, in judgement of the investigator；
- Must have at least 1 measurable lesion assessable using standard techniques by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)
- Adequate hematologic and organ function
- Signed inform consent form
Who cannot join
- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan.
- Significant cardiovascular disease
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring
- History of autoimmune disease.
- Subjects with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of first administration of study treatment. Inhaled or topical steroids, and adrenal replacement steroid are permitted in the absence of active autoimmune disease.
- Positive test result for human immunodeficiency virus (HIV); Active hepatitis B or hepatitis C
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- Active or untreated central nervous system (CNS) metastases
- Active infection within 2 weeks
- History of severe (or known) hypersensitivity to chimeric or humanized antibodies or fusion proteins
- Prior allogeneic bone marrow transplantation or solid organ transplant
- History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the safety of SHR-1702 monotherapy or in combination with Camrelizumab among advanced solid tumor subjects.
- Conditions
- Advanced Solid Tumor
- Being tested
- SHR-1702, Camrelizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-1702Drug
Administered IV
CamrelizumabDrug
Administered IV
| Study group | Role | What they receive |
|---|---|---|
| A:SHR-1702 Dose Escalation | Experimental | SHR-1702 given intravenously (IV). Receives: Drug: SHR-1702 |
| B:SHR-1702 Dose Expansion | Experimental | SHR-1702 given intravenously (IV). Receives: Drug: SHR-1702 |
| C:SHR-1702 and Camrelizumab Dose Escalation | Experimental | SHR-1702 and Camrelizumab given intravenously (IV). Receives: Drug: SHR-1702; Drug: Camrelizumab |
| D:SHR-1702 and Camrelizumab Dose Expansion | Experimental | SHR-1702 and Camrelizumab given intravenously (IV). Receives: Drug: SHR-1702; Drug: Camrelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with DLTs
Measured: Approximately 28 Days
Secondary outcomes (10)
ORR: Percentage of Participants With a CR or PR
Measured: Approximately 2 years
Safety and tolerability of SHR -1702 using Common Terminology Criteria for Adverse Events.
Measured: Dose Escalation Part -- Approximately 2 years
Immunogenicity as assessed by the presence of anti-drug antibodies
Measured: Approximately 2 years
Pharmacodynamic profile as assessed by receptor occupancy
Measured: Approximately 2 years
PK Parameter: Maximum Concentration (Cmax)
Measured: Approximately 2 years
PK Parameter: AUC, 0 to infinity
Measured: Approximately 2 years
PK Parameter: Clearance (CL)
Measured: Approximately 2 years
PK Parameter: Cmin at steady state (Cmin,ss)
Measured: Approximately 2 years
PK Parameter: Cmax at steady state (Cmax, ss)
Measured: Approximately 2 years
PK Parameter: terminal half-life (t1/2)
Measured: Approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2019
- Study start28 Apr 2019
- Primary completion21 Jun 2021
- Study completion21 Jun 2021
Why it stopped: Sponsor R \& D Strategy Adjustment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03871855
- Sponsor's protocol ID
- SHR-1702-I-101
- Status last verified
- Jun 2023
- First submitted
- 17 Feb 2019
- Last updated
- 5 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of SHR-1702 Alone or With Camrelizumab in Participants With Advanced Relapsed/Refractory Solid Tumors
- ClinicalTrials.gov ID
- NCT03871855
- Acronym / sponsor ID
- SHR-1702-I-101
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor R \& D Strategy Adjustment
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Apr 2019 (actual)
- Primary completion
- 21 Jun 2021 (actual)
- Study completion
- 21 Jun 2021 (actual)
- First posted
- 12 Mar 2019 (actual)
- 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 purpose of this study is to evaluate the safety of SHR-1702 monotherapy or in combination with Camrelizumab among advanced solid tumor subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A:SHR-1702 Dose Escalation | Experimental | Drug: SHR-1702SHR-1702 given intravenously (IV). |
| B:SHR-1702 Dose Expansion | Experimental | Drug: SHR-1702SHR-1702 given intravenously (IV). |
| C:SHR-1702 and Camrelizumab Dose Escalation | Experimental | Drug: SHR-1702, Drug: CamrelizumabSHR-1702 and Camrelizumab given intravenously (IV). |
| D:SHR-1702 and Camrelizumab Dose Expansion | Experimental | Drug: SHR-1702, Drug: CamrelizumabSHR-1702 and Camrelizumab given intravenously (IV). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histologically or cytologically confirmed advanced relapsed/refractory solid tumors
- Must have a performance status of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG) scale
- Have an estimated life expectancy of 12 weeks, in judgement of the investigator；
- Must have at least 1 measurable lesion assessable using standard techniques by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)
- Adequate hematologic and organ function
Key exclusion criteria (11 listed)
- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan.
- Significant cardiovascular disease
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring
- History of autoimmune disease.
- Subjects with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of first administration of study treatment. Inhaled or topical steroids, and adrenal replacement steroid are permitted in the absence of active autoimmune 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 |
|---|---|---|
| SHR-1702Administered IV | Drug | A:SHR-1702 Dose Escalation, B:SHR-1702 Dose Expansion, C:SHR-1702 and Camrelizumab Dose Escalation, D:SHR-1702 and Camrelizumab Dose Expansion |
| CamrelizumabAdministered IV | Drug | C:SHR-1702 and Camrelizumab Dose Escalation, D:SHR-1702 and Camrelizumab Dose Expansion |
Primary outcome
Number of Participants with DLTs
Time frame: Approximately 28 Days
10 secondary outcomes
ORR: Percentage of Participants With a CR or PR
Time frame: Approximately 2 years
Safety and tolerability of SHR -1702 using Common Terminology Criteria for Adverse Events.
Time frame: Dose Escalation Part -- Approximately 2 years
Immunogenicity as assessed by the presence of anti-drug antibodies
Time frame: Approximately 2 years
Pharmacodynamic profile as assessed by receptor occupancy
Time frame: Approximately 2 years
PK Parameter: Maximum Concentration (Cmax)
Time frame: Approximately 2 years
PK Parameter: AUC, 0 to infinity
Time frame: Approximately 2 years
PK Parameter: Clearance (CL)
Time frame: Approximately 2 years
PK Parameter: Cmin at steady state (Cmin,ss)
Time frame: Approximately 2 years
PK Parameter: Cmax at steady state (Cmax, ss)
Time frame: Approximately 2 years
PK Parameter: terminal half-life (t1/2)
Time frame: Approximately 2 years
Results and safety
The study was stopped early (reason given: Sponsor R \& D Strategy Adjustment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 SHR-1702 and Camrelizumab in people with Advanced Solid Tumor, 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 6 inclusion and 11 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: stopped early, as of the sponsor's last update on 5 Jun 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 was stopped early (reason given: Sponsor R \& D Strategy Adjustment). 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 DLTs (time frame: Approximately 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 5 Jun 2023.