CClinicalTrials.gg
Sign In
RecruitingNCT07231211Updated Sep 10, 2026

A Study of SHR-4610 Injection in Patients With Advanced Solid Tumors

A Phase 1/2 interventional study of SHR-4610 Injection and SHR-A1811 for injection in Solid Tumors, sponsored by Shanghai Shengdi Pharmaceutical Co., Ltd. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-10.

Sponsored by Shanghai Shengdi Pharmaceutical Co., Ltd · Phase 1/2, Interventional, and Treatment

From the registry’s dates

  • Started Nov 2025; still recruiting 10 months later.
Phase
Phase 1/2
Study type
Interventional
Enrollment
258
Allocation
Non-randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Solid Tumors
03

In context

Lead sponsor

Shanghai Shengdi Pharmaceutical Co., Ltd is the lead sponsor of 9 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Subjects must voluntarily agree to participate in the trial and sign a written informed consent form;
  2. Age range: 18-75 years old, both male and female are welcome;
  3. 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;
  4. Have at least one measurable tumor lesion per RECIST v1.1;
  5. ECOG performance status of 0-1;
  6. Life expectancy ≥ 12 weeks;
  7. Adequate bone marrow and organ function.

Exclusion criteria

Exclusion Criteria:

  1. Patients with active central nervous system metastases or meningeal metastases;
  2. Systemic antitumor therapy was received 4 weeks before the start of the study;
  3. Moderate or severe ascites with clinical symptoms; Uncontrolled or moderate or higher pleural effusion or pericardial effusion;
  4. Have poorly controlled or severe cardiovascular disease;
  5. Subjects with active hepatitis B or active hepatitis C;
  6. Adverse reactions of previous anti-tumor treatment have not recovered to Grade ≤ 1 per NCI-CTCAE v5.0.
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
258 participants (estimated)

Study arms

  • Experimental
    Cohort 1 Group

    SHR-4610 dose A in dose escalation stage.

    Drug: SHR-4610 Injection

  • Experimental
    Cohort 2 Group

    SHR-4610 dose B in dose escalation stage.

    Drug: SHR-4610 Injection

  • Experimental
    Cohort 3 Group

    SHR-4610 dose C in dose escalation stage.

    Drug: SHR-4610 Injection

  • Experimental
    Cohort 4 Group

    SHR-4610 dose D in dose escalation stage.

    Drug: SHR-4610 Injection

  • Experimental
    Cohort 5 Group

    SHR-4610 dose A/B/C/D in dose expansion stage.

    Drug: SHR-4610 Injection

  • Experimental
    Cohort 6 Group

    SHR-4610 dose A/B/C/D in efficacy expansion stage.

    Drug: SHR-4610 Injection

  • Experimental
    Cohort 7：SHR-4610 dose D +SHR-A1811 dose A in Satefy run in Stage

    Drug: SHR-4610 Injection · Drug: SHR-A1811 for injection

  • Experimental
    Cohort 8：SHR-4610 dose D+SHR-A1811 dose A in Satefy run in Efficacy expansion stage

    Drug: SHR-4610 Injection · Drug: SHR-A1811 for injection

Interventions

  • DrugSHR-4610 Injection

    SHR-4610 injection

  • DrugSHR-A1811 for injection

    SHR-A1811 for injection

06

What researchers measure

Primary outcomes

  1. The Dose-Limiting Toxicity (DLT)

    Time frame: Post-dose at day 1 to the end of treatment visit, about 1 year.

  2. The Maximum Tolerated Dose (MTD)

    Time frame: Post-dose at day 1 to the end of treatment visit, about 1 year.

  3. Recommended dosage for Phase II (RP2D)

    Time frame: Post-dose at day 1 to the end of treatment visit, about 1 year.

  4. Incidence and severity of adverse events (AEs)

    Time frame: Up to 90 days after the last administration.

Secondary outcomes

  1. Objective Response Rate (ORR)

    Time frame: From the first administration to the end of treatment visit, about 1 year.

  2. Duration of relief (DOR)

    Time frame: From the first administration to the end of treatment visit, about 1 year.

  3. Disease Control Rate (DCR)

    Time frame: From the first administration to the end of treatment visit, about 1 year.

  4. Time to Response (TTR)

    Time frame: From the first administration to the end of treatment visit, about 1 year.

  5. Progression-free survival (PFS)

    Time frame: From the first administration to the end of treatment visit, about 1 year.

  6. Time to the maximum plasma concentration (Tmax)

    Time frame: From Day 1 pre-dose to 30 days after the last administration.

  7. Maximum concentration of SHR-4610 (Cmax)

    Time frame: From Day 1 pre-dose to 30 days after the last administration.

  8. SHR-4610 serum trough concentration (Ctrough)

    Time frame: From Day 1 pre-dose to 30 days after the last administration.

  9. 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.

07

Study locations

1 of 1 sites recruiting
  • Zhejiang Cancer Hospital
    Hangzhou, Zhejiang 310022, China
    • Xiangdong Cheng · Contact · Chengxd1316@126.com · +86-0571-88888888
    • Xiangdong Cheng · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07231211
Lead sponsor
Shanghai Shengdi Pharmaceutical Co., Ltd
Responsible party
Sponsor
First posted
Nov 17, 2025
Start date
Nov 20, 2025
Primary completion
Oct 2026 (estimated)
Completion
Dec 2027 (estimated)
Last update
Sep 10, 2026

Study contacts

Yunpeng Jin
Contact
yunpeng.jin.yj1@hengrui.com
+86-021-61053363
Yuting Wang
Contact
yuting.wang@hengrui.com
+86-021-61053363

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Shanghai Shengdi Pharmaceutical Co., Ltd

Start the discussion