Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT07106827

A Study of GV20-0251 in Advanced or Refractory Solid Tumors

Led by West China Hospital · Updated on 2025-11-24

10

Participants Needed

1

Research Sites

144 weeks

Total Duration

On this page

Sponsors

W

West China Hospital

Lead Sponsor

G

GV20 Therapeutics

Collaborating Sponsor

AI-Summary

What this Trial Is About

This is a single-arm, single-center study for multiple tumor indications to evaluate the safety of GV20-0251. The trial uses a 3 + 3 design and enrolls 3-6 patients in the 10 mg/kg and 20 mg/kg dose groups, respectively. The cancer types include solid tumors.

CONDITIONS

Official Title

A Study of GV20-0251 in Advanced or Refractory Solid Tumors

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Voluntarily sign informed consent before any study procedures
  • Willing and able to participate throughout the entire study and follow procedures
  • Aged 18 years or older
  • Have a histologically confirmed advanced solid tumor with progressive disease requiring therapy
  • Refractory or intolerant to standard therapies and must have received standard care
  • ECOG performance status of 0 or 1 before first treatment day
  • Disease-free of active second or prior malignancies for at least 2 years
  • Laboratory test results within required ranges
  • Women of childbearing potential and men must agree to use effective contraception
Not Eligible

You will not qualify if you...

  • Diagnosis of acute leukemia or chronic lymphocytic leukemia
  • History of heart disease, myocardial infarction within 6 months, or unstable arrhythmia
  • QTcF interval greater than 470 msec or congenital long QT syndrome or significant ECG abnormalities
  • Active uncontrolled infections requiring systemic therapy within 7 days of first treatment
  • Active autoimmune disease or requiring chronic steroid or immunosuppressive therapy
  • Known HIV, hepatitis B, or hepatitis C infection unless specific conditions are met
  • History of major organ or bone marrow transplant
  • Symptomatic central nervous system malignancy or metastasis
  • Serious nonmalignant disease
  • Pregnant or nursing women
  • Major surgery within 28 days before first dose
  • Prior anticancer therapy within 4 weeks or 5 half-lives before first dose (exceptions apply)
  • History of severe allergic reactions to biologic therapy
  • Radiation therapy for symptomatic lesions within 14 days before first dose
  • Active substance abuse
  • History of immune-related grade 3 or higher adverse events from prior cancer immunotherapy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

West China Hospital

Chengdu, Sichuan, China

Actively Recruiting

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Research Team

J

Jin Zhou

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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