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

NCT07106827 | Recruiting Phase 1

• 1 other identifier: 2025-852
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

HCC - Hepatocellular Carcinoma; Cholangiocarcinoma; Melanoma; NSCLC (Non-small Cell Lung Cancer); Pancreatic Ductal Adenocarcinoma; HNSCC; Endometrial Cancer; Testicular Cancer

Keywords

GV20-0251

Outcome Measures

Primary Outcomes (1)

• Evaluate GV20-0251 safety

  Safety should be evaluated according to CTCAE5.0

  From Cycle 1 Day 1 dosing (each cycle is 21 days) until meeting the study termination criteria or 2 years

Study Arms (1)

GV20-0251 Treatment

EXPERIMENTAL

GV20-0251 safety in Advanced/Refractory Solid Tumors

Drug: GV20-0251

Interventions

GV20-0251 DRUG

Increasing doses of GV20-0251 administered by intravenous (IV) infusion once every 3 weeks

GV20-0251 Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Before conducting any study-specific procedures, voluntarily sign an informed consent form.
• Be able and willing to participate throughout the entire study period and comply with study procedures.
• participants ≥18 years of age
• Previously treated, histologically-confirmed advanced solid malignancy with progressive disease requiring therapy (Refractory or intolerant to standard therapies, must have received the standard of care therapy)
• ECOG performance status of 0 or 1 before C1D1
• Disease-free of active second/secondary or prior malignancies for ≥ 2 years Laboratory test results within the required parameters
• Women of childbearing potential (WOCBP) and men must agree to use adequate contraception

You may not qualify if:

• Participants with acute leukemia or CLL
• Participant with heart disease, myocardial infarction within the past 6 months, or unstable arrhythmia
• Fridericia-corrected QT interval (QTcF) \> 470 msec, or the presence of congenital long QT syndrome, or a history of clinically significant electrocardiogram (ECG) abnormalities (including pericarditis) that, in the investigator's judgment, may affect the subject's safety.
• Active, uncontrolled bacterial, viral, or fungal infections requiring systemic therapy within 7 days of Cycle 1 Day 1 (C1D1)
• Participant has active autoimmune disease or other medical conditions requiring chronic systemic steroid or immunosuppressive therapy
• Known human immunodeficiency virus (HIV) infection, known hepatitis B virus (HBV), or hepatitis C virus (HCV) infection, unless meeting the specific conditions.
• History of major organ transplant and/or a bone marrow transplant
• Symptomatic central nervous system (CNS) malignancy or metastasis
• Serious nonmalignant disease
• Pregnant or nursing women
• Major surgery within 28 days prior to the first dose of study medication
• Prior anticancer therapy within 4 weeks or 5 half-lives (whichever is shorter) before the first dose of GV20-0251 on Cycle 1 Day 1 (C1D1), with the exceptions.
• History of severe allergic reactions to biologic therapy, which in the investigator's judgment may increase the subject's risk.
• Radiation therapy for symptomatic lesions within 14 days prior to C1D1 dosing.
• Active substance abuse

Sponsors & Collaborators

• West China Hospital: lead
• GV20 Therapeutics: collaborator

Study Sites (1)

West China Hospital

Chengdu, Sichuan, China

RECRUITING

Related Publications (1)

• Li Y, Wu X, Sheng C, Liu H, Liu H, Tang Y, Liu C, Ding Q, Xie B, Xiao X, Zheng R, Yu Q, Guo Z, Ma J, Wang J, Gao J, Tian M, Wang W, Zhou J, Jiang L, Gu M, Shi S, Paull M, Yang G, Yang W, Landau S, Bao X, Hu X, Liu XS, Xiao T. IGSF8 is an innate immune checkpoint and cancer immunotherapy target. Cell. 2024 May 23;187(11):2703-2716.e23. doi: 10.1016/j.cell.2024.03.039. Epub 2024 Apr 23.

  PMID: 38657602 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Cholangiocarcinoma; Melanoma; Carcinoma, Non-Small-Cell Lung; Squamous Cell Carcinoma of Head and Neck; Endometrial Neoplasms; Testicular Neoplasms

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Squamous Cell; Head and Neck Neoplasms; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Endocrine Gland Neoplasms; Genital Neoplasms, Male; Genital Diseases, Male; Male Urogenital Diseases; Endocrine System Diseases; Testicular Diseases; Gonadal Disorders

Central Study Contacts

Jin Zhou

CONTACT

+8618980600172; zhoujin096@scu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 9, 2025
• First Posted: August 6, 2025
• Study Start: September 4, 2025
• Primary Completion (Estimated): June 11, 2027
• Study Completion (Estimated): June 11, 2028
• Last Updated: November 24, 2025

Record last verified: 2025-11

Locations

CN (1)