Malignant Solid TumorsPhase 1/2NCT07229612
A Phase I/II Clinical Study of SHR-4298 Injection in Patients With Malignant Solid Tumors
A Phase 1/2 study testing SHR-4298 Injection in people with Malignant Solid Tumors, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. at 1 site in China.
Trial summary
This study is an open-label, multicenter Phase I/II clinical trial to evaluate the safety, tolerability and efficacy of SHR-4298 injection in patients with malignant solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Malignant Solid Tumors
- What is being tested?
- SHR-4298 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
- 3 Dec 2025to Nov 2028
- 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
- Subjects must voluntarily agree to participate in the trial and sign a written informed consent form.
- ECOG performance score of 0-1.
- Life expectancy ≥ 3 months.
- Have at least one measurable tumor lesion per RECIST v1.1.
- Patients with recurrent or metastatic solid tumors confirmed by histopathology and not amenable to radical surgery or radical chemoradiotherapy.
- Good level of organ function.
- Provide archived or fresh tumor tissue for vendor test.
Who cannot join
- Subjects with active central nervous system metastases or meningeal metastases.
- Suffering from other malignant tumors within five years before the first use of the drug.
- History of serious cardiovascular and cerebrovascular diseases.
- Clinically significant bleeding symptoms occurred within 3 months before the first dose of study drug.
- Subjects with uncontrolled tumor-related pain.
- Clinically uncontrollable third space effusion or third space effusion requiring intervention within 7 days before the first study treatment.
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- Subjects who had a serious infection within 4 weeks before the first dose of the drug.
- History of immunodeficiency, including a positive HIV test or active hepatitis B or C.
- Subjects who received > 30 Gy of chest radiotherapy within 24 weeks before the first dose of the drug, subjects who received > 30 Gy of non-chest radiotherapy within 4 weeks before the first dose of the drug, and subjects who received ≤ 30 Gy of palliative radiation within 14 days before the first dose of the drug.
- Underwent major organ surgery within 28 days before the first dose of the drug.
- Those who are known to be allergic to any ingredients or excipients of SHR-4298 product.
- Administered a live attenuated vaccine within 28 days before the first dose.
- Female subjects who are pregnant, breastfeeding, or planning to become pregnant during the study.
- Per the investigator's judgment, there are any other circumstances that may increase the risk of participating in the study, interfere with the study results, or make participation in the study inappropriate.
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
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510032
Chengzhi Zhou, +86-13560351186, doctorzcz@163.com
Chengzhi Zhou
About this study
Official title: A Multicenter, Open-label Phase I/II Clinical Study on the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-4298 Injection in Patients With Malignant Solid Tumors
This study is an open-label, multicenter Phase I/II clinical trial to evaluate the safety, tolerability and efficacy of SHR-4298 injection in patients with malignant solid tumors.
- Conditions
- Malignant Solid Tumors
- Being tested
- SHR-4298 Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-4298 InjectionDrug
SHR-4298 injection.
| Study group | Role | What they receive |
|---|---|---|
| SHR-4298 Group | Experimental | Not described Receives: Drug: SHR-4298 Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events (AEs).
Measured: Approximately 18 months.
Incidence and severity of serious adverse events (SAEs).
Measured: Approximately 18 months.
Maximum Tolerated Dose (MTD).
Measured: Approximately 18 months.
Maximum Applicable Dose (MAD).
Measured: Approximately 18 months.
Recommended Phase 2 Dose (RP2D).
Measured: Approximately 18 months.
Dose-limiting toxicity (DLT).
Measured: Approximately 18 months.
Secondary outcomes (5)
Overall response rate (ORR).
Measured: Approximately 18 months.
Duration of response (DoR).
Measured: Approximately 18 months.
Disease control rate (DCR).
Measured: Approximately 18 months.
Progression-free survival (PFS).
Measured: Approximately 18 months.
Overall survival (OS).
Measured: Approximately 5 years after the last subject enrolled.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2025
- Study start3 Dec 2025
- Primary completionNov 2028 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant 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
- 200 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
- NCT07229612
- Sponsor's protocol ID
- SHR-4298-101
- Status last verified
- Aug 2026
- First submitted
- 13 Nov 2025
- Last updated
- 12 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 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label Phase I/II Clinical Study on the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-4298 Injection in Patients With Malignant Solid Tumors
- ClinicalTrials.gov ID
- NCT07229612
- Acronym / sponsor ID
- SHR-4298-101
- Conditions
- Malignant Solid Tumors
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 3 Dec 2025 (actual)
- Primary completion
- Nov 2028 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 17 Nov 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 study is an open-label, multicenter Phase I/II clinical trial to evaluate the safety, tolerability and efficacy of SHR-4298 injection in patients with malignant 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-4298 Group | Experimental | Drug: SHR-4298 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)
- Subjects must voluntarily agree to participate in the trial and sign a written informed consent form.
- ECOG performance score of 0-1.
- Life expectancy ≥ 3 months.
- Have at least one measurable tumor lesion per RECIST v1.1.
- Patients with recurrent or metastatic solid tumors confirmed by histopathology and not amenable to radical surgery or radical chemoradiotherapy.
Key exclusion criteria (14 listed)
- Subjects with active central nervous system metastases or meningeal metastases.
- Suffering from other malignant tumors within five years before the first use of the drug.
- History of serious cardiovascular and cerebrovascular diseases.
- Clinically significant bleeding symptoms occurred within 3 months before the first dose of study drug.
- Subjects with uncontrolled tumor-related pain.
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-4298 InjectionSHR-4298 injection. | Drug | SHR-4298 Group |
Primary outcome
Incidence and severity of adverse events (AEs).
Time frame: Approximately 18 months.
Incidence and severity of serious adverse events (SAEs).
Time frame: Approximately 18 months.
Maximum Tolerated Dose (MTD).
Time frame: Approximately 18 months.
Maximum Applicable Dose (MAD).
Time frame: Approximately 18 months.
Recommended Phase 2 Dose (RP2D).
Time frame: Approximately 18 months.
Dose-limiting toxicity (DLT).
Time frame: Approximately 18 months.
5 secondary outcomes
Overall response rate (ORR).
Time frame: Approximately 18 months.
Duration of response (DoR).
Time frame: Approximately 18 months.
Disease control rate (DCR).
Time frame: Approximately 18 months.
Progression-free survival (PFS).
Time frame: Approximately 18 months.
Overall survival (OS).
Time frame: Approximately 5 years after the last subject enrolled.
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 12 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-4298 Injection in people with Malignant 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 7 inclusion and 14 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 12 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 Lulu Yang (+86-0518-82342973, lulu.yang.ly103@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of adverse events (AEs). (time frame: Approximately 18 months.). The study lists 6 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 12 Aug 2026.