Solid TumorPhase 1NCT07830199
A Clinical Study of SHR-4595 Injection in Patients With Advanced Solid Tumors to Evaluate Safety, Tolerability and Pharmacokinetics
A Phase 1 study testing SHR-4595 for Injection in people with Solid Tumor, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. at 2 sites in China.
Trial summary
The study is being conducted to evaluate the safety and tolerability of SHR-4595 for injection in participants with advanced solid tumors, and to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD), and recommended dose for Phase II clinical studies (RP2D) of SHR-4595. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- SHR-4595 for Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 2 sitesChina
- Study dates
- 20 Oct 2026to Dec 2030
- Phase
- Phase 1
- 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
- A subject must satisfy all of the following criteria to be considered for inclusion in the study.
- 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
- A subject who meets any of the following criteria will be excluded from study entry.
- Symptomatic, untreated or active central nervous system metastases.
- Have uncontrolled or severe cardiovascular disease Have clinical symptoms or disease of the heart that are not well controlled.
- 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
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Cancer Hospital of Dalian University of Technology (Liaoning Cancer Hospital & Institute)
Shenyang, Liaoning, 110042
Yefu Liu, +86-024-88619613, LZLyf1111@163.com
Yefu Liu
- Recruiting
Tianjin Cancer Hospital
Tianjin, Tianjin Municipality, 300060
Jihui Hao, +86-022-23340123, haojihui@tjmuch.com
Jihui Hao
About this study
Official title: An Open-label, Multicenter Phase I Clinical Study of SHR-4595 Injection in Patients With Advanced Solid Tumors to Evaluate Safety, Tolerability and Pharmacokinetics
The study is being conducted to evaluate the safety and tolerability of SHR-4595 for injection in participants with advanced solid tumors, and to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD), and recommended dose for Phase II clinical studies (RP2D) of SHR-4595.
- Conditions
- Solid Tumor
- Being tested
- SHR-4595 for Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-4595 for InjectionDrug
SHR-4595 for injection, in different doses.
| Study group | Role | What they receive |
|---|---|---|
| SHR-4595 Group | Experimental | SHR-4595 for Injection, in different stages with different doses. Receives: Drug: SHR-4595 for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events (AEs)
Safety endpoints.
Measured: From Day 1 to 40 days after last dose.
Dose-limiting toxicity (DLT)
Safety endpoints.
Measured: From Day 1 to 12 months.
Maximum Tolerated Dose (MTD)
Safety endpoints.
Measured: From Day 1 to 12 months.
Recommended Phase 2 Dose (RP2D)
Safety endpoints.
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 posted21 Sep 2026
- Study start20 Oct 2026
- Primary completionDec 2029 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Monotherapy.
- 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
- NCT07830199
- Sponsor's protocol ID
- SHR-4595-101
- Status last verified
- Oct 2026
- First submitted
- 15 Sep 2026
- Last updated
- 2 Nov 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 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multicenter Phase I Clinical Study of SHR-4595 Injection in Patients With Advanced Solid Tumors to Evaluate Safety, Tolerability and Pharmacokinetics
- ClinicalTrials.gov ID
- NCT07830199
- Acronym / sponsor ID
- SHR-4595-101
- Conditions
- Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 208 participants (estimated)
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Oct 2026 (actual)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 21 Sep 2026 (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.
The study is being conducted to evaluate the safety and tolerability of SHR-4595 for injection in participants with advanced solid tumors, and to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD), and recommended dose for Phase II clinical studies (RP2D) of SHR-4595.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Monotherapy.
| Arm | Type | Receives |
|---|---|---|
| SHR-4595 Group | Experimental | Drug: SHR-4595 for InjectionSHR-4595 for Injection, in different stages with different doses. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- A subject must satisfy all of the following criteria to be considered for inclusion in the study.
- 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.
Key exclusion criteria (6 listed)
- A subject who meets any of the following criteria will be excluded from study entry.
- Symptomatic, untreated or active central nervous system metastases.
- Have uncontrolled or severe cardiovascular disease Have clinical symptoms or disease of the heart that are not well controlled.
- With any active autoimmune disease or history of autoimmune disease.
- Patients with active hepatitis B or hepatitis C.
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-4595 for InjectionSHR-4595 for injection, in different doses. | Drug | SHR-4595 Group |
Primary outcome
Adverse events (AEs)
Time frame: From Day 1 to 40 days after last dose.
Safety endpoints.
Dose-limiting toxicity (DLT)
Time frame: From Day 1 to 12 months.
Safety endpoints.
Maximum Tolerated Dose (MTD)
Time frame: From Day 1 to 12 months.
Safety endpoints.
Recommended Phase 2 Dose (RP2D)
Time frame: From Day 1 to 12 months.
Safety endpoints.
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 2 Nov 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SHR-4595 for Injection in people with Solid Tumor, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. at 2 sites 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 6 inclusion and 6 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 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 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.
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 Hongxia Han (+86-0518-82342973, hongxia.han@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 40 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 2 Nov 2026.