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Recruiting NCT07231211

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

Phase I / Phase II Interventional Solid Tumors

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SHR-4610 Injection.
Who it may be relevant to
Registry conditions: Solid Tumors. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Drug SHR-4610 Injection
    SHR-4610 injection in different dose.

Primary outcome measures

  • 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.]
Secondary outcome measures (9)
  • 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.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Zhejiang Cancer Hospital — Hangzhou

Identifiers

NCT: NCT07231211 · SHR-4610-101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗