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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorWest China Hospital

About this trial

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.

Eligibility criteria

Qualifiers

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)

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • GV20-0251

Treatment groups

10 Participants
are divided into 1 treatment group

Sponsors and collaborators

West China Hospital

Lead sponsor

GV20 Therapeutics

Collaborator