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NCT Number: NCT07231211

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

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.

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Key information

Conditions

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

Location status: Recruiting

Location contact

Xiangdong Cheng

CONTACT

[email protected]

+86-0571-88888888

Xiangdong Cheng

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

SHR-4610 Injection

Drug

SHR-4610 injection in different dose.

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Shanghai Shengdi Pharmaceutical Co., Ltd

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Nov 17, 2025
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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