Advanced Solid TumorsPhase 1NCT06618651
A Study of SHR-3821 Injection in Subjects With Advanced Solid Tumors
A Phase 1 study testing SHR-3821 injection in people with Advanced Solid Tumors, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. at 1 site in China.
Trial summary
This is an open label, multi-center, multiple dose Phase I study to evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-3821 injection in subjects with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- SHR-3821 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 1 siteChina
- Study dates
- 13 Nov 2024to 1 Jan 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- Voluntary participation and written informed consent.
- 18-75 years older, no gender limitation.
- Eastern Cooperative Oncology Group (ECOG) score: 0-1.
- With a life expectancy ≥ 3 months.
- Pathologically diagnosed advanced solid tumor.
- Be able to provide fresh or archived tumour tissue.
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- At least one measurable lesion according to RECIST v1.1.
- Adequate bone marrow reserve and organ function.
- Contraception is required during the trial.
Who cannot join
- Meningeal metastasis history or clinical symptoms of central nervous system metastasis.
- Uncontrollable tumor-related pain.
- Uncontrolled pleural effusion, pericardial effusion, or abdominal effusion with clinical symptoms.
- Received systemic antitumor therapy before the first dose.
- Treated with similar target therapy as SHR-3821 before the first dose.
- Received systemic anticancer treatments 4 weeks prior to the initiation of the study treatment.
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- Unresolved CTCAE 5.0>=grade 2 toxicities from previous anticancer therapy.
- Current or History of ILD.
- Active severe digestive disease.
- Previous or co-existing malignancies.
- History of severe hypersensitivity reactions to either the drug substances or inactive ingredients of SHR-3821.
- Active hepatitis B or active hepatitis C.
- Other inappropriate situation considered by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
West China Hospital of Sichuan Hospital
Chengdu, Sichuan, 610000
Jiankun Hu
About this study
Official title: Phase I Study of Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-3821 Injection in Subjects With Advanced Solid Tumors
This is an open label, multi-center, multiple dose Phase I study to evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-3821 injection in subjects with advanced solid tumors.
- Conditions
- Advanced Solid Tumors
- Being tested
- SHR-3821 injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-3821 injectionDrug
SHR-3821 injection
| Study group | Role | What they receive |
|---|---|---|
| SHR-3821 injection | Experimental | Not described Receives: Drug: SHR-3821 injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
DLT
Measured: 3 weeks
AE
Measured: Screening up to study completion, an average of 1 year
MTD
Measured: 3 weeks
RP2D
Measured: Screening up to study completion, an average of 1 year
Secondary outcomes (9)
Blood concentration of SHR-3821 after single and continuous administration
Measured: Screening up to study completion, an average of 1 year
PK parameters of SHR-3821 after single and continuous administration: Tmax
Measured: Screening up to study completion, an average of 1 year
PK parameters of SHR-3821 after single and continuous administration: Cmax
Measured: Screening up to study completion, an average of 1 year
PK parameters of SHR-3821 after single and continuous administration: AUC0-t
Measured: Screening up to study completion, an average of 1 year
Drug Resistant Antibody (ADA) to SHR-3821
Measured: Screening up to study completion, an average of 1 year
Objective response rate (ORR)
Measured: Screening up to study completion, an average of 1 year
Disease control rate (DCR)
Measured: Screening up to study completion, an average of 1 year
Progression-free survival (PFS)
Measured: Screening up to study completion, an average of 1 year
Overall survival (OS)
Measured: Screening up to study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start13 Nov 2024
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- More trials run by Suzhou Suncadia Biopharmaceuticals 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
- Model description
- To evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-3821 injection in subjects with advanced solid tumors.
- Masking
- None (open label)
- Enrolment
- 162 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06618651
- Sponsor's protocol ID
- SHR-3821-101
- Status last verified
- Nov 2025
- First submitted
- 26 Sep 2024
- Last updated
- 17 Nov 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 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-3821 Injection in Subjects With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06618651
- Acronym / sponsor ID
- SHR-3821-101
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 162 participants (estimated)
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 13 Nov 2024 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 1 Oct 2024 (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.
This is an open label, multi-center, multiple dose Phase I study to evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-3821 injection in subjects with advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- To evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-3821 injection in subjects with advanced solid tumors.
| Arm | Type | Receives |
|---|---|---|
| SHR-3821 injection | Experimental | Drug: SHR-3821 injection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Voluntary participation and written informed consent.
- 18-75 years older, no gender limitation.
- Eastern Cooperative Oncology Group (ECOG) score: 0-1.
- With a life expectancy ≥ 3 months.
- Pathologically diagnosed advanced solid tumor.
Key exclusion criteria (13 listed)
- Meningeal metastasis history or clinical symptoms of central nervous system metastasis.
- Uncontrollable tumor-related pain.
- Uncontrolled pleural effusion, pericardial effusion, or abdominal effusion with clinical symptoms.
- Received systemic antitumor therapy before the first dose.
- Treated with similar target therapy as SHR-3821 before the first dose.
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-3821 injectionSHR-3821 injection | Drug | SHR-3821 injection |
Primary outcome
DLT
Time frame: 3 weeks
AE
Time frame: Screening up to study completion, an average of 1 year
MTD
Time frame: 3 weeks
RP2D
Time frame: Screening up to study completion, an average of 1 year
9 secondary outcomes
Blood concentration of SHR-3821 after single and continuous administration
Time frame: Screening up to study completion, an average of 1 year
PK parameters of SHR-3821 after single and continuous administration: Tmax
Time frame: Screening up to study completion, an average of 1 year
PK parameters of SHR-3821 after single and continuous administration: Cmax
Time frame: Screening up to study completion, an average of 1 year
PK parameters of SHR-3821 after single and continuous administration: AUC0-t
Time frame: Screening up to study completion, an average of 1 year
Drug Resistant Antibody (ADA) to SHR-3821
Time frame: Screening up to study completion, an average of 1 year
Objective response rate (ORR)
Time frame: Screening up to study completion, an average of 1 year
Disease control rate (DCR)
Time frame: Screening up to study completion, an average of 1 year
Progression-free survival (PFS)
Time frame: Screening up to study completion, an average of 1 year
Overall survival (OS)
Time frame: Screening up to study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 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.
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-3821 injection in people with Advanced Solid Tumors, run by Suzhou Suncadia Biopharmaceuticals 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 9 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 17 Nov 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bin bai (+86 15618539080, bin.bai@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DLT (time frame: 3 weeks). The study lists 4 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 17 Nov 2025.