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Recruiting Phase 1/2

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

NCT07231211 · tracked via the Priya Life Science China tracker
Phase
Phase 1/2
Started
2025-11-20
Last updated
2026-09-10

Condition(s) studied

Solid Tumors

Investigational drug(s) / intervention(s)

SHR-4610 Injection →SHR-A1811 for injection →

SHR-4610 Injection: SHR-4610 injection

SHR-A1811 for injection: SHR-A1811 for injection

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

Sex
ALL
Min age
18 Years
Max age
75 Years
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: 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.

Primary outcome measure(s)

  • The Dose-Limiting Toxicity (DLT) — Post-dose at day 1 to the end of treatment visit, about 1 year.
  • The Maximum Tolerated Dose (MTD) — Post-dose at day 1 to the end of treatment visit, about 1 year.
  • Recommended dosage for Phase II (RP2D) — Post-dose at day 1 to the end of treatment visit, about 1 year.
  • Incidence and severity of adverse events (AEs) — Up to 90 days after the last administration.

Trial sites (1)

FacilityCityRegionStatus
Zhejiang Cancer Hospital Hangzhou Zhejiang Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07231211 on ClinicalTrials.gov ↗ ← All trials in China