Advanced Solid TumorPhase 1/2NCT07298772
A Study of SHR-4375 Injection in Combination With Other Antitumor Therapies in Patients With Solid Tumors
A Phase 1/2 study testing SHR-4375 Injection in people with Advanced Solid Tumor, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. at 1 site in China.
Trial summary
This is an open label, multi-center, Phase Ib/II study to evaluate the safety, tolerability and efficacy of SHR-4375 injection in combination with other antitumor therapies in patients 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 Tumor
- What is being tested?
- SHR-4375 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 1 siteChina
- Study dates
- 7 Jan 2026to Jan 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
- 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 ≥ 12 weeks.
- Patients with advanced solid tumors confirmed by cytology or histology who have failed or are intolerant to standard treatment and have no standard treatment.
- 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 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
- There are components of neuroendocrine carcinoma or sarcoma in the histopathological type.
- Had received chemotherapy, immunotherapy, targeted therapy, anti-tumor traditional Chinese medicine or other clinical research drugs within 4 weeks prior to the first administration of the study; Palliative radiotherapy was received within 2 weeks before the first administration.
- Live attenuated vaccines are used within a certain period of time before the first medication as stipulated in the plan, or it is expected that such vaccines will be needed during the treatment period.
- Having undergone major surgeries other than diagnosis or biopsy within 28 days prior to the first administration.
- Previously received antibody-drug conjugate therapy containing topoisomerase I inhibitors.
- Currently participating in other clinical studies or taking medication for the first time less than 4 weeks after the end of the previous clinical study.
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- Suffering from other active malignant tumors within 3 years or at the same time.
- Symptomatic or active central nervous system tumor metastasis.
- Accompanied by uncontrolled tumor related pain.
- Subjects who have experienced severe infections within 30 days prior to their first medication use.
- History of interstitial pneumonia/non infectious pneumonia requiring hormone therapy in the past.
- AE caused by previous anti-tumor treatment has not recovered to CTCAE v5.0 level evaluation ≤ 1.
- Active hepatitis B or active hepatitis C.
- Clinically significant bleeding symptoms or significant bleeding tendency occurred within 1 month before the first medication.
- Moderate and severe ascites with clinical symptoms; Uncontrolled or moderate to excessive pleural effusion and pericardial effusion.
- Uncontrollable mental illness and other conditions known to affect the completion of the study process, such as alcohol, drug or substance abuse, and criminal detention.
- 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
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Xianjun Yu, +86-021-64175590, yuxianjun@fudanpci.org
Xianjun Yu
About this study
Official title: A Phase Ib/II, Multicenter, Open-Label Study of Safety, Tolerability and Efficacy of SHR-4375 Injection in Combination With Other Antitumor Therapies in Patients With Advanced Solid Tumors
This is an open label, multi-center, Phase Ib/II study to evaluate the safety, tolerability and efficacy of SHR-4375 injection in combination with other antitumor therapies in patients with advanced solid tumors.
- Conditions
- Advanced Solid Tumor
- Being tested
- SHR-4375 Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-4375 InjectionDrug
SHR-4375 injection in combination with other antitumor therapies.
| Study group | Role | What they receive |
|---|---|---|
| SHR-4375 Injection in Combination With Other Antitumor Therapies Group | Experimental | Not described Receives: Drug: SHR-4375 Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose limiting toxicity (DLT).
Measured: 3 weeks.
Recommended phase II dose (RP2D).
Measured: From screening period up to study completion, an average of 1 year.
Adverse events (AEs).
Measured: From screening period up to study completion, an average of 1 year.
Objective response rate (ORR).
Measured: From screening period up to study completion, an average of 1 year.
Secondary outcomes (4)
Disease control rate (DCR)
Measured: From screening period up to study completion, an average of 1 year.
Duration of response (DoR)
Measured: From screening period up to study completion, an average of 1 year.
Progression-free survival (PFS)
Measured: From screening period up to study completion, an average of 1 year.
Drug Resistant Antibody (ADA) to SHR-4375
Immunogenicity: The number of subjects with ADA to SHR-4375, incidence, time of occurrence, duration, etc.
Measured: From screening period 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 posted23 Dec 2025
- Study start7 Jan 2026
- Primary completionJan 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies 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
- 198 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
- NCT07298772
- Sponsor's protocol ID
- SHR-4375-201
- Status last verified
- Apr 2026
- First submitted
- 9 Dec 2025
- Last updated
- 1 May 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 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib/II, Multicenter, Open-Label Study of Safety, Tolerability and Efficacy of SHR-4375 Injection in Combination With Other Antitumor Therapies in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT07298772
- Acronym / sponsor ID
- SHR-4375-201
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 198 participants (estimated)
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 7 Jan 2026 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 23 Dec 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, Phase Ib/II study to evaluate the safety, tolerability and efficacy of SHR-4375 injection in combination with other antitumor therapies in patients 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-4375 Injection in Combination With Other Antitumor Therapies Group | Experimental | Drug: SHR-4375 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 ≥ 12 weeks.
- Patients with advanced solid tumors confirmed by cytology or histology who have failed or are intolerant to standard treatment and have no standard treatment.
Key exclusion criteria (17 listed)
- There are components of neuroendocrine carcinoma or sarcoma in the histopathological type.
- Had received chemotherapy, immunotherapy, targeted therapy, anti-tumor traditional Chinese medicine or other clinical research drugs within 4 weeks prior to the first administration of the study; Palliative radiotherapy was received within 2 weeks before the first administration.
- Live attenuated vaccines are used within a certain period of time before the first medication as stipulated in the plan, or it is expected that such vaccines will be needed during the treatment period.
- Having undergone major surgeries other than diagnosis or biopsy within 28 days prior to the first administration.
- Previously received antibody-drug conjugate therapy containing topoisomerase I inhibitors.
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-4375 InjectionSHR-4375 injection in combination with other antitumor therapies. | Drug | SHR-4375 Injection in Combination With Other Antitumor Therapies Group |
Primary outcome
Dose limiting toxicity (DLT).
Time frame: 3 weeks.
Recommended phase II dose (RP2D).
Time frame: From screening period up to study completion, an average of 1 year.
Adverse events (AEs).
Time frame: From screening period up to study completion, an average of 1 year.
Objective response rate (ORR).
Time frame: From screening period up to study completion, an average of 1 year.
4 secondary outcomes
Disease control rate (DCR)
Time frame: From screening period up to study completion, an average of 1 year.
Duration of response (DoR)
Time frame: From screening period up to study completion, an average of 1 year.
Progression-free survival (PFS)
Time frame: From screening period up to study completion, an average of 1 year.
Drug Resistant Antibody (ADA) to SHR-4375
Time frame: From screening period 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 1 May 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-4375 Injection in people with Advanced Solid Tumor, 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 1 May 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 Yunpeng Jing (+86-0518-82342973, yunpeng.jin.yj1@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose limiting toxicity (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 1 May 2026.