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Recruiting Phase 1

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

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About this study

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.

Condition
HCC - Hepatocellular Carcinoma, Cholangiocarcinoma, Melanoma, NSCLC (Non-small Cell Lung Cancer), Pancreatic Ductal Adenocarcinoma, HNSCC, Endometrial Cancer, Testicular Cancer
Tested
GV20-0251
Sponsor
West China Hospital

Who can join

Age
18 years and older
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 9

  • Minimum age: 18 years
  • Study condition: HCC - Hepatocellular Carcinoma, Cholangiocarcinoma, Melanoma, NSCLC (Non-small Cell Lung Cancer), Pancreatic Ductal Adenocarcinoma, HNSCC, Endometrial Cancer, Testicular Cancer
  • 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

Exclusion 16

  • 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
  • Any history of an immune-related ≥ Grade 3 AE attributed to prior cancer immunotherapy

Where

1 site, 1 recruiting

West China Hospital

Chengdu, Sichuan, China

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.