Advanced Solid TumorPhase 2NCT05208177
A Study of SHR-1802 in Patients With Advanced Solid Tumor
A Phase 2 study testing SHR-1802＋camrelizumab + famitinib in people with Advanced Solid Tumor, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
To assess the safety and tolerability of SHR-1802 combined with camrelizumab and famitinib in subjects with advanced solid tumor and to determine the dose-limiting toxicity (DLT)，recommended phase II dose (RP2D) and assess objective response rate (ORR) assessed by the investigator based on RECIST v1.1 criteria. 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-1802＋camrelizumab + famitinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteChina
- Study dates
- 22 Apr 2022to 18 Aug 2023
- Phase
- Phase 2
- 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
- Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
- Has a life expectancy≥ 3 months;
- At least one measurable lesion according to RECIST v1.1;
- Pathologically confirmed advanced solid tumor;
- Adequate bone marrow reserve and organ function.
Who cannot join
- Have received prior therapy with camrelizumab, and famitinib;
- Received anti-tumor therapies such as chemotherapy, radiotherapy, biological therapy, targeted therapy, or immunotherapy within 4 weeks before the first dose of the treatment;
- Underwent a major surgery other than diagnosis or biopsy within 4 weeks before the first dose of the treatment;
- Have uncontrolled clinically symptomatic pleural effusion, pericardial effusion, or ascites;
- Have known history of arterial/venous thrombosis within 6 months prior to the first dose of the treatment, such as cerebrovascular accidents, deep vein thrombosis and pulmonary embolism;
- Grade II-IV cardiac insufficiency as per the New York Heart Association (NYHA) criteria; arrhythmia requiring long-term drug control; unstable angina or acute myocardial infarction within 6 months before the first dose of the treatment;
- Have other potential factors that may affect the study results or result in the premature discontinuation as determined by the investigator, such as alcoholism, drug abuse, substance abuse, other serious diseases (including mental illness) requiring concomitant treatment, serious laboratory abnormalities, or family or social factors that could affect the safety of medication.
Trial locations and contacts
1 site in 1 country.
China1 site
Tianjin Medical University Cancer Institute&Hospital
Tianjin, Tianjin Municipality, 300202
About this study
Official title: A Phase Ⅰb/Ⅱ Dose-exploration and Efficacy-expansion Study of SHR-1802 Combined With Camrelizumab for Injection and Famitinib Malate Capsules for the Treatment of Advanced Solid Tumor
To assess the safety and tolerability of SHR-1802 combined with camrelizumab and famitinib in subjects with advanced solid tumor and to determine the dose-limiting toxicity (DLT)，recommended phase II dose (RP2D) and assess objective response rate (ORR) assessed by the investigator based on RECIST v1.1 criteria.
- Conditions
- Advanced Solid Tumor
- Being tested
- SHR-1802＋camrelizumab + famitinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-1802＋camrelizumab + famitinibDrug
SHR-1802 for injection，q3w； Camrelizumab for injection, q3w; Famitinib malate capsules, qd.
| Study group | Role | What they receive |
|---|---|---|
| SHR-1802 for injection combined with Camrelizumab for Injection and Famitinib Malate Capsules | Experimental | Not described Receives: Drug: SHR-1802＋camrelizumab + famitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose limiting toxicity (DLT)
Measured: 4 weeks
Recommended phase II dose (RP2D)
Measured: up to 1 years
ORR
Objective Response Rate, determined according to RECIST v1.1 criteria
Measured: up to 2 years
Secondary outcomes (13)
DOR
Duration of Response, determined according to RECIST v1.1 criteria
Measured: up to 2 years
DCR
Disease Control Rate, determined according to RECIST v1.1 criteria
Measured: up to 2 years
PFS assessed by investigator
Progression Free Survival, determined according to RECIST v1.1 criteria
Measured: up to 2 years
TTR
Time to Response，determined according to RECIST v1.1 criteria
Measured: up to 2 years
OS (overall survival)
From date of treatment start to any cause death or last follow-up
Measured: up to 2 years
12-month OS rate
Measured: from the date of the first dose up to 2 years
AEs+SAEs
Adverse Events and Serious Adverse Events assessed by CTCAE v5.0
Measured: from the first drug administration to within 90 days for the last drug dose
Concentration of drug in serum
Serum concentration of Camrelizumab for Injection and SHR-1802 for injection.
Measured: 0.5 hour before the first dose up to 30 days after last dose
Concentration of drug in plasma
Plasma concentration of Famitinib malate capsule and its metabolite.
Measured: n the second cycle，predose 1 hour and 6 hours post-dose；In cycle 3, cycle 4, cycle 6, cycle 8, and cycle 10，predose 1 hour（each cycle is 21 days）
Count of T lymphocyte subsets
Count of CD4+ T lymphocyte subsets in peripheral blood；Count of CD8+ T lymphocyte subsets in peripheral blood.
Measured: 30 minutes before the first dose of SHR-1802, the 4th and 8th days after the first injection
Percentage of T lymphocyte subsets
Percentage of CD4+ T lymphocyte subsets in peripheral blood；Percentage of CD8+ T lymphocyte subsets in peripheral blood.
Measured: 30 minutes before the first dose of SHR-1802, the 4th and 8th days after the first injection
ADA
Anti-drug antibody of Camrelizumab for Injection and SHR-1802 for injection
Measured: up to 30 days after last dose
Nab
Neutralizing Antibody of Camrelizumab for Injection and SHR-1802 for injection.
Measured: up to 30 days after last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2022
- Study start22 Apr 2022
- Primary completion18 Aug 2023
- Study completion18 Aug 2023
Why it stopped: Adjustment of R\&D strategy
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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Dose-escalation: Traditional 3+3 dose-escalation design. Dose-expansion: 10 to 12 subjects (included subjects of the dose-escalation part) will be enrolled in each tolerable dose level. Efficacy-expansion: After determination of the recommended dose for Phase II (RP2D), selected cohorts with different tumor types will be expanded.
- Masking
- None (open label)
- Enrolment
- 25 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
- NCT05208177
- Sponsor's protocol ID
- SHR-1802-II-201
- Status last verified
- Aug 2025
- First submitted
- 18 Jan 2022
- Last updated
- 22 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ⅰb/Ⅱ Dose-exploration and Efficacy-expansion Study of SHR-1802 Combined With Camrelizumab for Injection and Famitinib Malate Capsules for the Treatment of Advanced Solid Tumor
- ClinicalTrials.gov ID
- NCT05208177
- Acronym / sponsor ID
- SHR-1802-II-201
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Adjustment of R\&D strategy
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 Apr 2022 (actual)
- Primary completion
- 18 Aug 2023 (actual)
- Study completion
- 18 Aug 2023 (actual)
- First posted
- 26 Jan 2022 (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.
To assess the safety and tolerability of SHR-1802 combined with camrelizumab and famitinib in subjects with advanced solid tumor and to determine the dose-limiting toxicity (DLT)，recommended phase II dose (RP2D) and assess objective response rate (ORR) assessed by the investigator based on RECIST v1.1 criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Dose-escalation: Traditional 3+3 dose-escalation design. Dose-expansion: 10 to 12 subjects (included subjects of the dose-escalation part) will be enrolled in each tolerable dose level. Efficacy-expansion: After determination of the recommended dose for Phase II (RP2D), selected cohorts with different tumor types will be expanded.
| Arm | Type | Receives |
|---|---|---|
| SHR-1802 for injection combined with Camrelizumab for Injection and Famitinib Malate Capsules | Experimental | Drug: SHR-1802＋camrelizumab + famitinib |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
- Has a life expectancy≥ 3 months;
- At least one measurable lesion according to RECIST v1.1;
- Pathologically confirmed advanced solid tumor;
Key exclusion criteria (7 listed)
- Have received prior therapy with camrelizumab, and famitinib;
- Received anti-tumor therapies such as chemotherapy, radiotherapy, biological therapy, targeted therapy, or immunotherapy within 4 weeks before the first dose of the treatment;
- Underwent a major surgery other than diagnosis or biopsy within 4 weeks before the first dose of the treatment;
- Have uncontrolled clinically symptomatic pleural effusion, pericardial effusion, or ascites;
- Have known history of arterial/venous thrombosis within 6 months prior to the first dose of the treatment, such as cerebrovascular accidents, deep vein thrombosis and pulmonary embolism;
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-1802＋camrelizumab + famitinibSHR-1802 for injection，q3w； Camrelizumab for injection, q3w; Famitinib malate capsules, qd. | Drug | SHR-1802 for injection combined with Camrelizumab for Injection and Famitinib Malate Capsules |
Primary outcome
Dose limiting toxicity (DLT)
Time frame: 4 weeks
Recommended phase II dose (RP2D)
Time frame: up to 1 years
ORR
Time frame: up to 2 years
Objective Response Rate, determined according to RECIST v1.1 criteria
13 secondary outcomes
DOR
Time frame: up to 2 years
DCR
Time frame: up to 2 years
PFS assessed by investigator
Time frame: up to 2 years
TTR
Time frame: up to 2 years
OS (overall survival)
Time frame: up to 2 years
12-month OS rate
Time frame: from the date of the first dose up to 2 years
AEs+SAEs
Time frame: from the first drug administration to within 90 days for the last drug dose
Concentration of drug in serum
Time frame: 0.5 hour before the first dose up to 30 days after last dose
Concentration of drug in plasma
Time frame: n the second cycle，predose 1 hour and 6 hours post-dose；In cycle 3, cycle 4, cycle 6, cycle 8, and cycle 10，predose 1 hour（each cycle is 21 days）
Count of T lymphocyte subsets
Time frame: 30 minutes before the first dose of SHR-1802, the 4th and 8th days after the first injection
Percentage of T lymphocyte subsets
Time frame: 30 minutes before the first dose of SHR-1802, the 4th and 8th days after the first injection
ADA
Time frame: up to 30 days after last dose
Nab
Time frame: up to 30 days after last dose
Results and safety
The study was stopped early (reason given: Adjustment of R\&D strategy). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- 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.
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 2 study testing SHR-1802＋camrelizumab + famitinib 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 7 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 22 Aug 2025. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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: Adjustment of R\&D strategy). 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?
Dose limiting toxicity (DLT) (time frame: 4 weeks). The study lists 3 primary outcomes in all. 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 22 Aug 2025.