Solid TumorsPhase 1/2NCT06764628
A Study of SHR-4375 in Subjects With Solid Tumors
A Phase 1/2 study testing SHR-4375 in people with Solid Tumors, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. at 1 site in China.
Trial summary
This is an open-label, three-part study to evaluate the safety and efficacy of SHR-4375 for injection in subjects with solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors
- What is being tested?
- SHR-4375
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 1 siteChina
- Study dates
- 9 Jan 2025to May 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subjects voluntarily joined the study and signed the ICF.
- Measurable disease, as defined by RECIST v1.1.
- The Eastern Cancer Cooperative Group (ECOG) performance status of 0 or 1.
- Life expectancy ≥ 12 weeks.
- Subjects with cytologically or histologically confirmed advanced solid tumors who have failed or are intolerant to standard therapy, have no standard therapy, or refuse standard therapy.
Who cannot join
- Symptomatic, untreated or active central nervous system metastases.
- With any active autoimmune disease or history of autoimmune disease.
- Patients with active hepatitis B or hepatitis C.
- Severe infections prior to initiation of study treatment.
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, 021-64175590, yuxianjun@fudanpci.org
Xiaohua Wu, 021-64175590 ext. 81000, wu.xh@fudan.edu.cn
About this study
Official title: An Open-label, Single-arm, Multicenter Phase I/II Clinical Study of SHR-4375 Injection in Patients With Advanced Solid Tumors to Evaluate Safety, Tolerability, Pharmacokinetics and Efficacy
This is an open-label, three-part study to evaluate the safety and efficacy of SHR-4375 for injection in subjects with solid tumors.
- Conditions
- Solid Tumors
- Being tested
- SHR-4375
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-4375Drug
SHR-4375 injection
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Not described Receives: Drug: SHR-4375 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events (AEs)
Measured: From Day 1 to 90 days after last dose.
Dose limiting toxicity (DLT)
Measured: From Day 1 to 12 months.
Maximal tolerable dose (MTD)
Measured: From Day 1 to 12 months.
Recommended phase 2 dose (RP2D)
Measured: From Day 1 to 12 months.
Secondary outcomes (5)
Progression free survival (PFS)
Measured: From Day 1 to 12 months.
Objective response rate (ORR)
Measured: From Day 1 to 12 months.
Disease control rate (DCR)
Measured: From Day 1 to 12 months.
Duration of response (DOR)
Measured: From Day 1 to 12 months.
Overall survival (OS)
Measured: From Day 1 to 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2025
- Study start9 Jan 2025
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (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 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
- 208 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
- NCT06764628
- Sponsor's protocol ID
- SHR-4375-101
- Status last verified
- Jan 2025
- First submitted
- 2 Jan 2025
- Last updated
- 22 Jan 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 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single-arm, Multicenter Phase I/II Clinical Study of SHR-4375 Injection in Patients With Advanced Solid Tumors to Evaluate Safety, Tolerability, Pharmacokinetics and Efficacy
- ClinicalTrials.gov ID
- NCT06764628
- Acronym / sponsor ID
- SHR-4375-101
- Conditions
- Solid Tumors
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 208 participants (estimated)
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 Jan 2025 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 8 Jan 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, three-part study to evaluate the safety and efficacy of SHR-4375 for injection in subjects with 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 |
|---|---|---|
| Treatment group | Experimental | Drug: SHR-4375 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The subjects voluntarily joined the study and signed the ICF.
- Measurable disease, as defined by RECIST v1.1.
- The Eastern Cancer Cooperative Group (ECOG) performance status of 0 or 1.
- Life expectancy ≥ 12 weeks.
- Subjects with cytologically or histologically confirmed advanced solid tumors who have failed or are intolerant to standard therapy, have no standard therapy, or refuse standard therapy.
Key exclusion criteria (4 listed)
- Symptomatic, untreated or active central nervous system metastases.
- With any active autoimmune disease or history of autoimmune disease.
- Patients with active hepatitis B or hepatitis C.
- Severe infections prior to initiation of study treatment.
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-4375SHR-4375 injection | Drug | Treatment group |
Primary outcome
Adverse events (AEs)
Time frame: From Day 1 to 90 days after last dose.
Dose limiting toxicity (DLT)
Time frame: From Day 1 to 12 months.
Maximal tolerable dose (MTD)
Time frame: From Day 1 to 12 months.
Recommended phase 2 dose (RP2D)
Time frame: From Day 1 to 12 months.
5 secondary outcomes
Progression free survival (PFS)
Time frame: From Day 1 to 12 months.
Objective response rate (ORR)
Time frame: From Day 1 to 12 months.
Disease control rate (DCR)
Time frame: From Day 1 to 12 months.
Duration of response (DOR)
Time frame: From Day 1 to 12 months.
Overall survival (OS)
Time frame: From Day 1 to 12 months.
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 22 Jan 2025.
- Individual participant dataSharing planned: Undecided
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RecruitingPhase 1
A Study of JNJ-95437446 in Participants With Advanced-Stage Solid Tumors
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RecruitingPhase 1/2
A Phase 1 and 2 Study of VMD-102 in Hepatocellular Carcinoma and Other Solid Tumors
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A Study of JNJ-1761981 in Participants With Solid Tumors
Neoplasms
Not yet recruitingPhase 1
GD2IL18CART Combined With Bevacizumab for Relapsed and Refractory GD2-positive Solid Tumors
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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 in people with 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 5 inclusion and 4 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 22 Jan 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 Yuanchao Wang (0518-82342973, yuanchao.wang@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (AEs) (time frame: From Day 1 to 90 days after last dose.). 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 22 Jan 2025.