Advanced Solid TumorsPhase 1/2NCT06906731
A Study of SHR-9803 for Injection in Patients With Advanced Solid Tumors
A Phase 1/2 study testing SHR-9803 in people with Advanced Solid Tumors, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
This is an open label, multi-center, multiple doses Phase I/II study to evaluate the safety, tolerability ,pharmacokinetics and efficacy of SHR-9803 for 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-9803
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteChina
- Study dates
- Apr 2025to Dec 2027
- 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
- Voluntary participation and written informed consent.
- 18-75 years old, no gender limitation.
- Eastern Cooperative Oncology Group (ECOG) score: 0-1
- With a life expectancy ≥ 3 months.
- Pathologically diagnosed advanced solid tumor.
- At least one measurable lesion according to RECIST v1.1.
- Adequate bone marrow reserve and organ function.
- Contraception is required during clinical trials, and pregnancy tests must be negative for women of childbearing age within 7 days before the first dose.
Who cannot join
- Have untreated central nervous system metastasis; or have meningeal metastasis or spinal cord compression;
- Uncontrolled clinically symptomatic pleural effusion, pericardial effusion, or ascites;
- Previous or co-existing malignancies；
- Severe bone damage caused by bone metastasis， including uncontrolled tumor-related pain;
- Have active or prior documented autoimmune disease;
- Have used corticosteroids (> 10 mg/day of prednisone or equivalent) or other immunosuppressive agents for systemic treatment within 2 weeks;
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- With poorly controlled or severe cardiovascular disease;
- A history of interstitial pneumonia/non-infectious pneumonia;
- Severe infection 1 month before the first dose;
- Active hepatitis B or hepatitis C, or with a history of immunodeficiency;
- With a history of inflammatory bowel disease, or those who have experienced intestinal obstruction or gastrointestinal perforation within 3 months prior to the first dose;
- Have received more than 30 Gy of pulmonary radiation therapy within 6 months prior to the first dose; Have received major surgery，Systemic chemotherapy, endocrine therapy, monoclonal antibody therapy, macromolecular targeted therapy or other investigational products within 4 weeks; or palliative radiotherapy within 2 weeks; or oral small-molecule targeted drugs within five half-lives;
- Have not recovered from the toxicities and/or complications of previous interventions to NCI-CTCAE Grade ≤ 1;
- Received live-attenuated vaccines within 4 weeks prior to the first dose.
- Known to have had an allergic reaction to other monoclonal antibodies.
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
Harbin Medical University cancer hospital
Harbin, Heilongjiang, 150081
Tongsen Zheng
About this study
Official title: An Open-label, Multicenter Phase I/II Study of Safety, Tolerability,Pharmacokinetics and Efficacy of SHR-9803 for Injection in Patients With Advanced Solid Tumors
This is an open label, multi-center, multiple doses Phase I/II study to evaluate the safety, tolerability ,pharmacokinetics and efficacy of SHR-9803 for injection in subjects with advanced solid tumors.
- Conditions
- Advanced Solid Tumors
- Being tested
- SHR-9803
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-9803Drug
SHR-9803
| Study group | Role | What they receive |
|---|---|---|
| SHR-9803 | Experimental | SHR-9803 Receives: Drug: SHR-9803 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limited Toxicity（Ia）
Measured: Screening up to the end of phase Ia, an average of 6 months
Dose Limited Toxicity (Ib)
Measured: Screening up to the end of phase Ib, an average of 1 year
Recommended phase II dose(Ib)
Measured: Screening up to the end of phase Ib, an average of 2 years
objective response rate(II)
Measured: Screening up to study completion, an average of 3 year
Secondary outcomes (4)
Adverse Events,
Measured: Screening up to study completion, an average of 3 year;
Disease Control Rate (DCR),
Measured: Screening up to study completion, an average of 3 year
Progression-Free Survival (PFS),
Measured: Screening up to study completion, an average of 3 year;
Plasma concentration of SHR-9803
Measured: Screening up to study completion, an average of 3 year;
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2025
- Study startApr 2025 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionDec 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 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (estimated)
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
- NCT06906731
- Sponsor's protocol ID
- SHR-9803-101
- Status last verified
- Mar 2025
- First submitted
- 26 Mar 2025
- Last updated
- 2 Apr 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 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multicenter Phase I/II Study of Safety, Tolerability,Pharmacokinetics and Efficacy of SHR-9803 for Injection in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06906731
- Acronym / sponsor ID
- SHR-9803-101
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2025 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 2 Apr 2025 (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 doses Phase I/II study to evaluate the safety, tolerability ,pharmacokinetics and efficacy of SHR-9803 for 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
| Arm | Type | Receives |
|---|---|---|
| SHR-9803 | Experimental | Drug: SHR-9803SHR-9803 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Voluntary participation and written informed consent.
- 18-75 years old, 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 (15 listed)
- Have untreated central nervous system metastasis; or have meningeal metastasis or spinal cord compression;
- Uncontrolled clinically symptomatic pleural effusion, pericardial effusion, or ascites;
- Previous or co-existing malignancies；
- Severe bone damage caused by bone metastasis， including uncontrolled tumor-related pain;
- Have active or prior documented 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-9803SHR-9803 | Drug | SHR-9803 |
Primary outcome
Dose Limited Toxicity（Ia）
Time frame: Screening up to the end of phase Ia, an average of 6 months
Dose Limited Toxicity (Ib)
Time frame: Screening up to the end of phase Ib, an average of 1 year
Recommended phase II dose(Ib)
Time frame: Screening up to the end of phase Ib, an average of 2 years
objective response rate(II)
Time frame: Screening up to study completion, an average of 3 year
4 secondary outcomes
Adverse Events,
Time frame: Screening up to study completion, an average of 3 year;
Disease Control Rate (DCR),
Time frame: Screening up to study completion, an average of 3 year
Progression-Free Survival (PFS),
Time frame: Screening up to study completion, an average of 3 year;
Plasma concentration of SHR-9803
Time frame: Screening up to study completion, an average of 3 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 2 Apr 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 1/2 study testing SHR-9803 in people with Advanced Solid Tumors, 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 8 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: opening soon, as of the sponsor's last update on 2 Apr 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 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 Weixia Li (+86 021-61053363, weixia.li@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Limited Toxicity（Ia） (time frame: Screening up to the end of phase Ia, an average of 6 months). 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 2 Apr 2025.