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

Last updated: January 7, 2026
Sponsor: Shanghai Shengdi Pharmaceutical Co., Ltd
Overall Status: Active - Recruiting

Phase

1/2

Condition

Solid Tumors

Treatment

SHR-4610 Injection

Clinical Study ID

NCT07231211
SHR-4610-101
  • Ages 18-75
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Subjects must voluntarily agree to participate in the trial and sign a writteninformed consent form;

  2. Age range: 18-75 years old, both male and female are welcome;

  3. Patients with histologically or cytologically confirmed unresectable locallyadvanced or metastatic solid tumors which is relapsed or refractory to standardtreatment, 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

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 orhigher 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 ≤ 1per NCI-CTCAE v5.0.

Study Design

Total Participants: 258
Treatment Group(s): 1
Primary Treatment: SHR-4610 Injection
Phase: 1/2
Study Start date:
November 20, 2025
Estimated Completion Date:
December 31, 2027

Connect with a study center

  • Zhejiang Cancer Hospital

    Hangzhou 1808926, Zhejiang 1784764 310022
    China

    Active - Recruiting

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