Menu
Recruiting NCT07068932

A Clinical Study of SHR-4506 Injection in Patients With Malignant Tumors

Phase I Interventional Malignant Tumors of Adults

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-4506 Injection.
Who it may be relevant to
Registry conditions: Malignant Tumors of Adults. Basic parameters: from 18 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

Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-4506 Injection in Patients With Malignant Tumors

Overview

The study is being conducted to evaluate the safety and tolerability of SHR-4506 Injection in patients with malignant tumors and to determine the maximum tolerated dose (MTD) or maximum administered dose (MAD).

Interventions

  • Drug SHR-4506 Injection
    SHR-4506 injection.

Primary outcome measures

  • Dose Limited Toxicities (DLTs) [Time frame: Up to 21 days.]
  • Maximum Tolerated Dose (MTD) [Time frame: Up to 21 days.]
  • Incidence and severity of adverse events (AEs) [Time frame: Up to 90 days after the last dose.]
  • Incidence and severity of serious adverse events (SAEs) [Time frame: Up to 90 days after the last dose.]
Secondary outcome measures (5)
  • Objective response rate (ORR) assessed by the investigator [Time frame: Up to 3 years.]
  • Objective tumor response duration (DoR) [Time frame: Up to 3 years.]
  • Disease control rate (DCR) [Time frame: Up to 3 years.]
  • Progression free survival (PFS) [Time frame: Up to 3 years.]
  • Overall survival (OS) [Time frame: Up to 3 years.]

Eligibility criteria

Inclusion criteria

  • Age ≥18 years, any gender.
  • ECOG performance status 0-1.
  • Histologically or cytologically confirmed malignant tumor patients who have failed standard therapy, or are intolerant to standard therapy, or have no standard treatment available.
  • Adequate organ function.
  • Voluntary participation in this clinical trial, with full understanding of study procedures and ability to provide written informed consent.
  • Expected survival ≥12 weeks.
  • Patients in the dose-expansion phase must have measurable lesions.
  • Agreement to use contraception from the time of signing the informed consent to at least 60 days after the last dose of the investigational drug.

Exclusion criteria

  • Prior treatment with the same class of investigational drug.
  • Confirmed or suspected central nervous system (CNS) tumor involvement.
  • Uncontrolled tumor-related pain.
  • Active autoimmune disease, history of immunodeficiency (including primary or secondary, e.g., HIV infection), or autoimmune disorders requiring systemic therapy.
  • Clinically significant cardiovascular disease history.
  • Known hypersensitivity to any component of the investigational drug.
  • Major surgery or significant trauma within 4 weeks prior to the first dose of the investigational drug; diagnostic or superficial surgery within 7 days before the first dose; or planned major surgery during the study period.
  • Adverse events from prior therapy have not recovered to ≤ CTCAE Grade 1.
  • Severe infection within 4 weeks before the first dose, or active infection within 2 weeks.
  • History of cerebrovascular accident within 6 months before the first dose of the investigational drug.
  • Patients with other active malignancies within 2 years prior to the first dose or concurrent malignancies.
  • Patients with any other condition judged by the investigator that makes the patient unsuitable for participation in the study.

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

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 2 centers
  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine — Shanghai
  • Renji Hospital, Shanghai Jiaotong University School of Medicine — Shanghai

Identifiers

NCT: NCT07068932 · SHR-4506-101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗