Advanced Solid TumorsPhase 1/2NCT06703177
A Study of SHR-1826 for Injection in Combination With Other Antitumor Therapies in Subjects With Solid Tumors
A Phase 1/2 study testing SHR-1826, SHR-4642 and SHR-9839 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 IB/II study to evaluate the safety, tolerability and efficacy of SHR-1826 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-1826, SHR-4642 and SHR-9839
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 876 participants
- Where
- 1 siteChina
- Study dates
- 18 Feb 2025to 1 Jul 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 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 clinical trials, and pregnancy tests must be negative for women of childbearing age within 7 days before the first dose.
Who cannot join
- Meningeal metastasis history or clinical symptoms of central nervous system metastasis;
- Previous or co-existing malignancies;
- Spinal cord compression that was not treated radically by surgery and/or radiotherapy was excluded;
- Uncontrollable tumor-related pain;
- Previously received antiboy-coupled drug therapy with topoisomerase I inhibitor toxin; Previously received EGFR/c-Met double antibody;
- Received systemic antitumor therapy before the first dose;
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- Have undergone major surgery other than diagnosis or biopsy within 28 days prior to initial dosing; Minor traumatic surgery within 7 days prior to first dosing;
- For the first time, a study was conducted to treat patients with radiation therapy exceeding the prescribed dose before study treatment;
- Received Other investigational drugs treatments 4 weeks prior to the initiation of the study treatment;
- Unresolved CTCAE 5.0>grade 2 toxicities from previous anticancer therapy;
- A history of interstitial pneumonia/non-infectious pneumonia;
- Accompanied by uncontrolled pleural effusion and pericardial effusion; Moderate or severe ascites with clinical symptoms;
- Study the presence of intestinal obstruction or the presence of signs or symptoms of intestinal obstruction 6 months before first dosing;
- With poorly controlled or severe cardiovascular disease;
- Active hepatitis B, hepatitis C;
- Patients with a history of immunodeficiency;
- Severe infection 30 days before the first dose.
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
Sun Yat-Sen university cancer center
Guangzhou, Guangdong, 510000
Ruihua Xu, +86-020-87343468, xurh@sysucc.org.cn
Ruihua Xu
About this study
Official title: Phase IB/II Study of Safety, Tolerability and Efficacy of SHR-1826 for Injection in Combination With Other Antitumor Therapies in Subjects With Solid Tumors
This is an open label, multi-center, multiple dose Phase IB/II study to evaluate the safety, tolerability and efficacy of SHR-1826 for injection in subjects with advanced solid tumors.
- Conditions
- Advanced Solid Tumors
- Being tested
- SHR-1826, SHR-4642, SHR-9839, SHR-8068, Bevacizumab Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-1826Drug
SHR-1826
SHR-4642Drug
SHR-4642
SHR-9839Drug
SHR-9839
SHR-8068Drug
SHR-8068
Bevacizumab InjectionDrug
Bevacizumab Injection
Fluorouracil InjectionDrug
Fluorouracil Injection
Calcium Folinate InjectionDrug
Calcium Folinate Injection
Adebrelimab InjectionDrug
Adebrelimab Injection
Capecitabine tabletsDrug
Capecitabine tablets, oral.
| Study group | Role | What they receive |
|---|---|---|
| Single group | Experimental | Not described Receives: Drug: SHR-1826; Drug: SHR-4642; Drug: SHR-9839; Drug: SHR-8068; Drug: Bevacizumab Injection; Drug: Fluorouracil Injection; Drug: Calcium Folinate Injection; Drug: Adebrelimab Injection; Drug: Capecitabine tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
RP2D (Phase 1)
Measured: Screening up to study completion, an average of 1 year.
AE (Phase 1)
Measured: Screening up to study completion, an average of 1 year.
Objective response rate (ORR) (Phase 2)
Measured: Screening up to study completion, an average of 1 year.
Secondary outcomes (13)
Objective response rate (ORR) (Phase 1)
Measured: Screening up to study completion, an average of 1 year.
Disease control rate (DCR) (Phase 1)
Measured: Screening up to study completion, an average of 1 year.
Duration of response (DoR) (Phase 1)
Measured: Screening up to study completion, an average of 1 year.
Progression-free survival (PFS) (Phase 1)
Measured: Screening up to study completion, an average of 1 year.
Overall survival (OS) (Phase 1)
Measured: Screening up to study completion, an average of 1 year.
Drug Resistant Antibody (ADA) (Phase 1)
Measured: Screening up to study completion, an average of 1 year.
Blood concentration of SHR-1826 (Phase 1)
Measured: Screening up to study completion, an average of 1 year.
Blood concentration of free toxin SHR169265 (Phase 1)
Measured: Screening up to study completion, an average of 1 year.
Disease control rate (DCR) (Phase 2)
Measured: Screening up to study completion, an average of 1 year.
Duration of response (DoR) (Phase 2)
Measured: Screening up to study completion, an average of 1 year.
Progression-free survival (PFS) (Phase 2)
Measured: Screening up to study completion, an average of 1 year.
Overall survival (OS) (Phase 2)
Measured: Screening up to study completion, an average of 1 year.
AE (Phase 2)
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 posted25 Nov 2024
- Study start18 Feb 2025
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jul 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 876 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
- NCT06703177
- Sponsor's protocol ID
- SHR-1826-201
- Status last verified
- Nov 2025
- First submitted
- 19 Nov 2024
- Last updated
- 3 Dec 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 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IB/II Study of Safety, Tolerability and Efficacy of SHR-1826 for Injection in Combination With Other Antitumor Therapies in Subjects With Solid Tumors
- ClinicalTrials.gov ID
- NCT06703177
- Acronym / sponsor ID
- SHR-1826-201
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 876 participants (estimated)
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 18 Feb 2025 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 25 Nov 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 IB/II study to evaluate the safety, tolerability and efficacy of SHR-1826 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 |
|---|---|---|
| Single group | Experimental | Drug: SHR-1826, Drug: SHR-4642, Drug: SHR-9839, Drug: SHR-8068, Drug: Bevacizumab Injection, Drug: Fluorouracil Injection, Drug: Calcium Folinate Injection, Drug: Adebrelimab Injection, Drug: Capecitabine tablets |
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 (17 listed)
- Meningeal metastasis history or clinical symptoms of central nervous system metastasis;
- Previous or co-existing malignancies;
- Spinal cord compression that was not treated radically by surgery and/or radiotherapy was excluded;
- Uncontrollable tumor-related pain;
- Previously received antiboy-coupled drug therapy with topoisomerase I inhibitor toxin; Previously received EGFR/c-Met double antibody;
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-1826SHR-1826 | Drug | Single group |
| SHR-4642SHR-4642 | Drug | Single group |
| SHR-9839SHR-9839 | Drug | Single group |
| SHR-8068SHR-8068 | Drug | Single group |
| Bevacizumab InjectionBevacizumab Injection | Drug | Single group |
| Fluorouracil InjectionFluorouracil Injection | Drug | Single group |
| Calcium Folinate InjectionCalcium Folinate Injection | Drug | Single group |
| Adebrelimab InjectionAdebrelimab Injection | Drug | Single group |
| Capecitabine tabletsCapecitabine tablets, oral. | Drug | Single group |
Primary outcome
RP2D (Phase 1)
Time frame: Screening up to study completion, an average of 1 year.
AE (Phase 1)
Time frame: Screening up to study completion, an average of 1 year.
Objective response rate (ORR) (Phase 2)
Time frame: Screening up to study completion, an average of 1 year.
13 secondary outcomes
Objective response rate (ORR) (Phase 1)
Time frame: Screening up to study completion, an average of 1 year.
Disease control rate (DCR) (Phase 1)
Time frame: Screening up to study completion, an average of 1 year.
Duration of response (DoR) (Phase 1)
Time frame: Screening up to study completion, an average of 1 year.
Progression-free survival (PFS) (Phase 1)
Time frame: Screening up to study completion, an average of 1 year.
Overall survival (OS) (Phase 1)
Time frame: Screening up to study completion, an average of 1 year.
Drug Resistant Antibody (ADA) (Phase 1)
Time frame: Screening up to study completion, an average of 1 year.
Blood concentration of SHR-1826 (Phase 1)
Time frame: Screening up to study completion, an average of 1 year.
Blood concentration of free toxin SHR169265 (Phase 1)
Time frame: Screening up to study completion, an average of 1 year.
Disease control rate (DCR) (Phase 2)
Time frame: Screening up to study completion, an average of 1 year.
Duration of response (DoR) (Phase 2)
Time frame: Screening up to study completion, an average of 1 year.
Progression-free survival (PFS) (Phase 2)
Time frame: Screening up to study completion, an average of 1 year.
Overall survival (OS) (Phase 2)
Time frame: Screening up to study completion, an average of 1 year.
AE (Phase 2)
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 3 Dec 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-1826, SHR-4642 and SHR-9839 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 17 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 3 Dec 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 Rongfu Mao, MD (+86-021-61053363, rongfu.mao@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RP2D (Phase 1) (time frame: Screening up to study completion, an average of 1 year.). 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 3 Dec 2025.