Solid TumorsPhase 1/2NCT07231211
A Study of SHR-4610 Injection in Patients With Advanced Solid Tumors
A Phase 1/2 study testing SHR-4610 Injection and SHR-A1811 for injection in people with Solid Tumors, run by Shanghai Shengdi Pharmaceutical Co., Ltd at 1 site in China.
Trial summary
This study is an open, multicenter Phase I/II clinical trial, divided into two stages: dose exploration (including dose escalation and dose extension) and efficacy extension. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Solid Tumors
- What is being tested?
- SHR-4610 Injection and SHR-A1811 for injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 258 participants
- Where
- 1 siteChina
- Study dates
- 20 Nov 2025to Dec 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
- Subjects must voluntarily agree to participate in the trial and sign a written informed consent form;
- Age range: 18-75 years old, both male and female are welcome;
- Patients with histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumors which is relapsed or refractory to standard treatment, or lack of standard treatment;
- Have at least one measurable tumor lesion per RECIST v1.1;
- ECOG performance status of 0-1;
- Life expectancy ≥ 12 weeks;
- Adequate bone marrow and organ function.
Who cannot join
- Patients with active central nervous system metastases or meningeal metastases;
- Systemic antitumor therapy was received 4 weeks before the start of the study;
- Moderate or severe ascites with clinical symptoms; Uncontrolled or moderate or higher pleural effusion or pericardial effusion;
- Have poorly controlled or severe cardiovascular disease;
- Subjects with active hepatitis B or active hepatitis C;
- Adverse reactions of previous anti-tumor treatment have not recovered to Grade ≤ 1 per NCI-CTCAE v5.0.
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
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Xiangdong Cheng, +86-0571-88888888, Chengxd1316@126.com
Xiangdong Cheng
About this study
Official title: An Open-label, Multicenter Phase I/II Clinical Study of SHR-4610 Injection in Patients With Advanced Solid Tumors to Evaluate Safety, Tolerability, Pharmacokinetics and Efficacy
This study is an open, multicenter Phase I/II clinical trial, divided into two stages: dose exploration (including dose escalation and dose extension) and efficacy extension.
- Conditions
- Solid Tumors
- Being tested
- SHR-4610 Injection, SHR-A1811 for injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-4610 InjectionDrug
SHR-4610 injection
SHR-A1811 for injectionDrug
SHR-A1811 for injection
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 Group | Experimental | SHR-4610 dose A in dose escalation stage. Receives: Drug: SHR-4610 Injection |
| Cohort 2 Group | Experimental | SHR-4610 dose B in dose escalation stage. Receives: Drug: SHR-4610 Injection |
| Cohort 3 Group | Experimental | SHR-4610 dose C in dose escalation stage. Receives: Drug: SHR-4610 Injection |
| Cohort 4 Group | Experimental | SHR-4610 dose D in dose escalation stage. Receives: Drug: SHR-4610 Injection |
| Cohort 5 Group | Experimental | SHR-4610 dose A/B/C/D in dose expansion stage. Receives: Drug: SHR-4610 Injection |
| Cohort 6 Group | Experimental | SHR-4610 dose A/B/C/D in efficacy expansion stage. Receives: Drug: SHR-4610 Injection |
| Cohort 7：SHR-4610 dose D +SHR-A1811 dose A in Satefy run in Stage | Experimental | Not described Receives: Drug: SHR-4610 Injection; Drug: SHR-A1811 for injection |
| Cohort 8：SHR-4610 dose D+SHR-A1811 dose A in Satefy run in Efficacy expansion stage | Experimental | Not described Receives: Drug: SHR-4610 Injection; Drug: SHR-A1811 for injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Dose-Limiting Toxicity (DLT)
Measured: Post-dose at day 1 to the end of treatment visit, about 1 year.
The Maximum Tolerated Dose (MTD)
Measured: Post-dose at day 1 to the end of treatment visit, about 1 year.
Recommended dosage for Phase II (RP2D)
Measured: Post-dose at day 1 to the end of treatment visit, about 1 year.
Incidence and severity of adverse events (AEs)
Measured: Up to 90 days after the last administration.
Secondary outcomes (9)
Objective Response Rate (ORR)
Measured: From the first administration to the end of treatment visit, about 1 year.
Duration of relief (DOR)
Measured: From the first administration to the end of treatment visit, about 1 year.
Disease Control Rate (DCR)
Measured: From the first administration to the end of treatment visit, about 1 year.
Time to Response (TTR)
Measured: From the first administration to the end of treatment visit, about 1 year.
Progression-free survival (PFS)
Measured: From the first administration to the end of treatment visit, about 1 year.
Time to the maximum plasma concentration (Tmax)
Measured: From Day 1 pre-dose to 30 days after the last administration.
Maximum concentration of SHR-4610 (Cmax)
Measured: From Day 1 pre-dose to 30 days after the last administration.
SHR-4610 serum trough concentration (Ctrough)
Measured: From Day 1 pre-dose to 30 days after the last administration.
Area under the concentration versus time curve of SHR-4610 from time zero to time t (AUC0-t)
Measured: From Day 1 pre-dose to 30 days after the last administration.
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 start20 Nov 2025
- Primary completionOct 2026 (estimated)
- Study completionDec 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.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 258 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Shengdi Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07231211
- Sponsor's protocol ID
- SHR-4610-101
- Status last verified
- Jan 2026
- First submitted
- 13 Nov 2025
- Last updated
- 10 Sep 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 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multicenter Phase I/II Clinical Study of SHR-4610 Injection in Patients With Advanced Solid Tumors to Evaluate Safety, Tolerability, Pharmacokinetics and Efficacy
- ClinicalTrials.gov ID
- NCT07231211
- Acronym / sponsor ID
- SHR-4610-101
- Conditions
- Solid Tumors
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 258 participants (estimated)
- Lead sponsor
- Shanghai Shengdi Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 20 Nov 2025 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Dec 2027 (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, multicenter Phase I/II clinical trial, divided into two stages: dose exploration (including dose escalation and dose extension) and efficacy extension.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 Group | Experimental | Drug: SHR-4610 InjectionSHR-4610 dose A in dose escalation stage. |
| Cohort 2 Group | Experimental | Drug: SHR-4610 InjectionSHR-4610 dose B in dose escalation stage. |
| Cohort 3 Group | Experimental | Drug: SHR-4610 InjectionSHR-4610 dose C in dose escalation stage. |
| Cohort 4 Group | Experimental | Drug: SHR-4610 InjectionSHR-4610 dose D in dose escalation stage. |
| Cohort 5 Group | Experimental | Drug: SHR-4610 InjectionSHR-4610 dose A/B/C/D in dose expansion stage. |
| Cohort 6 Group | Experimental | Drug: SHR-4610 InjectionSHR-4610 dose A/B/C/D in efficacy expansion stage. |
| Cohort 7：SHR-4610 dose D +SHR-A1811 dose A in Satefy run in Stage | Experimental | Drug: SHR-4610 Injection, Drug: SHR-A1811 for injection |
| Cohort 8：SHR-4610 dose D+SHR-A1811 dose A in Satefy run in Efficacy expansion stage | Experimental | Drug: SHR-4610 Injection, Drug: SHR-A1811 for 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;
- Age range: 18-75 years old, both male and female are welcome;
- Patients with histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumors which is relapsed or refractory to standard treatment, or lack of standard treatment;
- Have at least one measurable tumor lesion per RECIST v1.1;
- ECOG performance status of 0-1;
Key exclusion criteria (6 listed)
- Patients with active central nervous system metastases or meningeal metastases;
- Systemic antitumor therapy was received 4 weeks before the start of the study;
- Moderate or severe ascites with clinical symptoms; Uncontrolled or moderate or higher pleural effusion or pericardial effusion;
- Have poorly controlled or severe cardiovascular disease;
- Subjects with active hepatitis B or active 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-4610 InjectionSHR-4610 injection | Drug | Cohort 1 Group, Cohort 2 Group, Cohort 3 Group, Cohort 4 Group, Cohort 5 Group, Cohort 6 Group, Cohort 7：SHR-4610 dose D +SHR-A1811 dose A in Satefy run in Stage, Cohort 8：SHR-4610 dose D+SHR-A1811 dose A in Satefy run in Efficacy expansion stage |
| SHR-A1811 for injectionSHR-A1811 for injection | Drug | Cohort 7：SHR-4610 dose D +SHR-A1811 dose A in Satefy run in Stage, Cohort 8：SHR-4610 dose D+SHR-A1811 dose A in Satefy run in Efficacy expansion stage |
Primary outcome
The Dose-Limiting Toxicity (DLT)
Time frame: Post-dose at day 1 to the end of treatment visit, about 1 year.
The Maximum Tolerated Dose (MTD)
Time frame: Post-dose at day 1 to the end of treatment visit, about 1 year.
Recommended dosage for Phase II (RP2D)
Time frame: Post-dose at day 1 to the end of treatment visit, about 1 year.
Incidence and severity of adverse events (AEs)
Time frame: Up to 90 days after the last administration.
9 secondary outcomes
Objective Response Rate (ORR)
Time frame: From the first administration to the end of treatment visit, about 1 year.
Duration of relief (DOR)
Time frame: From the first administration to the end of treatment visit, about 1 year.
Disease Control Rate (DCR)
Time frame: From the first administration to the end of treatment visit, about 1 year.
Time to Response (TTR)
Time frame: From the first administration to the end of treatment visit, about 1 year.
Progression-free survival (PFS)
Time frame: From the first administration to the end of treatment visit, about 1 year.
Time to the maximum plasma concentration (Tmax)
Time frame: From Day 1 pre-dose to 30 days after the last administration.
Maximum concentration of SHR-4610 (Cmax)
Time frame: From Day 1 pre-dose to 30 days after the last administration.
SHR-4610 serum trough concentration (Ctrough)
Time frame: From Day 1 pre-dose to 30 days after the last administration.
Area under the concentration versus time curve of SHR-4610 from time zero to time t (AUC0-t)
Time frame: From Day 1 pre-dose to 30 days after the last administration.
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 10 Sep 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-4610 Injection and SHR-A1811 for injection in people with Solid Tumors, run by Shanghai Shengdi Pharmaceutical 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 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 10 Sep 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 Jin (+86-021-61053363, 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?
The Dose-Limiting Toxicity (DLT) (time frame: Post-dose at day 1 to the end of treatment visit, about 1 year.). 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 10 Sep 2026.