Solid TumorsPhase 1/2NCT07769242
Phase I/II Clinical Trials of SHR-8203 Injection in Participants With Advanced Solid Tumors
A Phase 1/2 study testing SHR-8203 Injection in people with Solid Tumors, run by Beijing Suncadia Pharmaceuticals Co., Ltd at 1 site in China.
Trial summary
This trial is a multicenter, open-label Phase I/II clinical study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and efficacy of SHR-8203 injection in participants with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Solid Tumors
- What is being tested?
- SHR-8203 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2026to 30 Dec 2029
- Phase
- Phase 1/2
- 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
- Age between 18 and 75 years old, gender not limited;
- Be willing to participate and abide by the requirements of the research protocol, and be willing to cooperate with the follow-up.
- Participants with advanced or metastatic solid tumors confirmed by histological or cytological pathology who have failed standard treatment (disease progression or toxic intolerance) or have no effective standard treatment;
- Able to provide sufficient fresh or archived tumor tissue specimens for the third-party central laboratory designated by the sponsor.
- Have at least one measurable lesion as per RECIST v1.1;
- ECOG PS score: 0-1;
- Good organ function level.
Who cannot join
- Imaging studies show that the tumor invades major blood vessels or has an unclear boundary with blood vessels, and researchers determine that there is a risk of massive hemorrhage;
- Suffering from hypertension and unable to achieve good control through antihypertensive drug treatment;
- Pleural effusion, pericardial effusion or peritoneal effusion accompanied by clinical symptoms, poorly controlled, or moderate to severe;
- Major arterial or venous thrombosis events occurred within 6 months before the first administration of medication;
- Participants who have experienced severe infections within one month prior to the first medication.
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
Shanghai East Hospital
Shanghai, Shanghai Municipality, 200433
Caicun Zhou, 021-58822171, caicunzhoudr@163.com
About this study
Official title: An Open-label, Multi-center Phase I/II Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of SHR-8203 Injection in Participants With Advanced Solid Tumors
This trial is a multicenter, open-label Phase I/II clinical study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and efficacy of SHR-8203 injection in participants with advanced solid tumors.
- Conditions
- Solid Tumors
- Being tested
- SHR-8203 Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-8203 InjectionDrug
SHR-8203 Injection Dose 1/ Dose 2/ Dose 3/ Dose 4
| Study group | Role | What they receive |
|---|---|---|
| SHR-8203 Injection | Experimental | Not described Receives: Drug: SHR-8203 Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of subjects with dose-limiting toxicity (DLT)
Measured: From first dose of study treatment until the end of Cycle 1（up to 21 days）
Incidence and severity of AEs
Measured: From the first visit to the end of the safety follow-up period (1 year)
Maximum Tolerated Dose
Measured: During the DLT observation period, the dose level at which the estimated toxicity probability was closest to the target toxicity probability (i.e., 0.3)（up to 21 days）
Determination of Recommended Phase II dose (RP2D)
Measured: After dose optimization, sufficient safety, tolerability, PK and preliminary efficacy results were obtained, and the dose selected for the subsequent indication expansion stage was confirmed by SRC discussion (1 year).
Objective Response Rate (ORR)
Measured: From time of first dose of SHR-8203 until the date of objective disease progression or death (1 year)
Secondary outcomes (4)
Duration of Response (DoR)
Measured: From time of first dose of objective disease progression until the date of objective disease progression or death (1 year)
Disease Control Rate (DCR)
Measured: From time of first dose of SHR-8203 until the date of objective disease progression or death (1 year)
Progression free Survival (PFS)
Progression-free survival is defined as the time from the start of treatment until the date of objective disease progression or death.
Measured: From time of first dose of objective disease progression until the date of objective disease progression or death (1 year)
Overall Survival (OS)
The time until death due to any cause.
Measured: From time of first dose of objective disease progression until the date of death (2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion30 Dec 2029 (estimated)
- Study completion30 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- More trials run by Beijing Suncadia Pharmaceuticals Co., LtdThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Suncadia Pharmaceuticals Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07769242
- Sponsor's protocol ID
- SHR-8203-101
- Status last verified
- Aug 2026
- First submitted
- 12 Aug 2026
- Last updated
- 17 Aug 2026
- 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 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multi-center Phase I/II Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of SHR-8203 Injection in Participants With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT07769242
- Acronym / sponsor ID
- SHR-8203-101
- Conditions
- Solid Tumors
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Beijing Suncadia Pharmaceuticals Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 30 Dec 2029 (estimated)
- Study completion
- 30 Dec 2029 (estimated)
- First posted
- 17 Aug 2026 (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 trial is a multicenter, open-label Phase I/II clinical study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and efficacy of SHR-8203 injection in participants with advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SHR-8203 Injection | Experimental | Drug: SHR-8203 Injection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age between 18 and 75 years old, gender not limited;
- Be willing to participate and abide by the requirements of the research protocol, and be willing to cooperate with the follow-up.
- Participants with advanced or metastatic solid tumors confirmed by histological or cytological pathology who have failed standard treatment (disease progression or toxic intolerance) or have no effective standard treatment;
- Able to provide sufficient fresh or archived tumor tissue specimens for the third-party central laboratory designated by the sponsor.
- Have at least one measurable lesion as per RECIST v1.1;
Key exclusion criteria (5 listed)
- Imaging studies show that the tumor invades major blood vessels or has an unclear boundary with blood vessels, and researchers determine that there is a risk of massive hemorrhage;
- Suffering from hypertension and unable to achieve good control through antihypertensive drug treatment;
- Pleural effusion, pericardial effusion or peritoneal effusion accompanied by clinical symptoms, poorly controlled, or moderate to severe;
- Major arterial or venous thrombosis events occurred within 6 months before the first administration of medication;
- Participants who have experienced severe infections within one month prior to the first medication.
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-8203 InjectionSHR-8203 Injection Dose 1/ Dose 2/ Dose 3/ Dose 4 | Drug | SHR-8203 Injection |
Primary outcome
The number of subjects with dose-limiting toxicity (DLT)
Time frame: From first dose of study treatment until the end of Cycle 1（up to 21 days）
Incidence and severity of AEs
Time frame: From the first visit to the end of the safety follow-up period (1 year)
Maximum Tolerated Dose
Time frame: During the DLT observation period, the dose level at which the estimated toxicity probability was closest to the target toxicity probability (i.e., 0.3)（up to 21 days）
Determination of Recommended Phase II dose (RP2D)
Time frame: After dose optimization, sufficient safety, tolerability, PK and preliminary efficacy results were obtained, and the dose selected for the subsequent indication expansion stage was confirmed by SRC discussion (1 year).
Objective Response Rate (ORR)
Time frame: From time of first dose of SHR-8203 until the date of objective disease progression or death (1 year)
4 secondary outcomes
Duration of Response (DoR)
Time frame: From time of first dose of objective disease progression until the date of objective disease progression or death (1 year)
Disease Control Rate (DCR)
Time frame: From time of first dose of SHR-8203 until the date of objective disease progression or death (1 year)
Progression free Survival (PFS)
Time frame: From time of first dose of objective disease progression until the date of objective disease progression or death (1 year)
Overall Survival (OS)
Time frame: From time of first dose of objective disease progression until the date of death (2 years)
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 Aug 2026.
- 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 1/2 study testing SHR-8203 Injection in people with Solid Tumors, run by Beijing Suncadia Pharmaceuticals 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 7 inclusion and 5 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: opening soon, as of the sponsor's last update on 17 Aug 2026. 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 combined 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.
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?
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 Fang fang Peng, Doctoral degree (17721288185, fangfang.peng.fp5@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of subjects with dose-limiting toxicity (DLT) (time frame: From first dose of study treatment until the end of Cycle 1（up to 21 days）). The study lists 5 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 Aug 2026.