IGSF8 is an innate immune checkpoint and cancer immunotherapy target.
Yulong Li, Xiangyang Wu, Caibin Sheng...
https://pubmed.ncbi.nlm.nih.gov/38657602Actively Recruiting
Phase 1
Age: 18Years +
All Genders
ID07106827
Single Arm Clinical Study Protocol of GV20-0251 in the Treatment of Advanced or Refractory Solid Tumors
Led by West China Hospital · Updated on 2025-11-24
10
Participants Needed
1
Research Sites
52 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
Researchers are evaluating the safety of GV20-0251 in adults with advanced or refractory solid tumors. This single-arm, single-center Phase I trial uses a 3 + 3 dose escalation design involving various cancer types such as hepatocellular carcinoma, cholangiocarcinoma, melanoma, non-small cell lung cancer, pancreatic ductal adenocarcinoma, and others. The study aims to determine the safety profile of GV20-0251 at different dose levels. The trial includes two dose groups: 10 mg/kg and 20 mg/kg, each given every three weeks by intravenous infusion. Patients receive GV20-0251 through a saline bag infusion prepared by study personnel. Dose escalation proceeds based on the occurrence of dose-limiting toxicities during 21-day observation periods. If patients cannot tolerate a dose, adjustments may be made with approval from the clinical trial committee. Participants undergo a screening period lasting up to 28 days before treatment begins. During the study, researchers monitor safety from the first dose for up to two years or until study termination criteria are met. Assessments include calculating individual doses based on body weight and supervising drug administration. The primary outcome is to evaluate the safety of GV20-0251 through careful observation during treatment cycles of 21 days each.
CONDITIONS
Brief Title
A Study of GV20-0251 in Advanced or Refractory Solid Tumors
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Voluntarily sign an informed consent form before any study procedures
- Be willing and able to participate throughout the entire study and follow all procedures
- Be 18 years of age or older
- Have a histologically confirmed advanced solid tumor with progressive disease despite standard therapies
- Have an ECOG performance status of 0 or 1 before starting treatment
- Be free of active second or prior malignancies for at least 2 years
- Women of childbearing potential and men must agree to use adequate contraception
You will not qualify if you...
- Diagnosis of acute leukemia or chronic lymphocytic leukemia (CLL)
- History of heart disease, recent 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 treatment within 7 days before treatment start
- Active autoimmune disease or need for chronic systemic steroid or immunosuppressive therapy
- Known HIV, hepatitis B, or hepatitis C infection unless meeting specific conditions
- History of major organ or bone marrow transplant
- Symptomatic central nervous system malignancy or metastasis
- Serious nonmalignant diseases
- Pregnancy or nursing
- Major surgery within 28 days before first treatment dose
- Recent anticancer therapy within 4 weeks or 5 half-lives before treatment
- History of severe allergic reactions to biologic therapy as judged by investigator
- Radiation therapy for symptomatic lesions within 14 days before treatment
- 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
1
2
3
Your Study Journey
Screening
Duration - Up to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Treatment
Duration - Repeated 21-day cycles until meeting study termination criteria or up to 2 years
Participants receive increasing doses of GV20-0251 administered by intravenous infusion once every 3 weeks under supervision.
One infusion visit every 3 weeks
Trial Site Locations
Total: 1 location
1
West China Hospital
Chengdu, Sichuan, China
Actively Recruiting
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Research Team
J
Jin Zhou
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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