Actively Recruiting
Study of GV20-0251 in Participants With Solid Tumor Malignancies
Led by GV20 Therapeutics · Updated on 2025-12-03
350
Participants Needed
3
Research Sites
166 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a Phase 1 and Phase 2 study of GV20-0251 being developed for the treatment of participants with advanced solid tumors, who are refractory to approved therapies or other standard of care.
CONDITIONS
Official Title
Study of GV20-0251 in Participants With Solid Tumor Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be 18 years of age or older
- Provide voluntary informed consent before any study procedures
- Have histologically confirmed advanced solid malignancy with progressive disease requiring therapy
- Be refractory or intolerant to standard therapies and must have received standard of care
- Have measurable disease per RECIST version 1.1
- Documented disease progression if previously treated with checkpoint inhibitors
- ECOG performance status of 0 or 1 before first treatment cycle
- Willing to provide fresh tumor biopsy pre-treatment and on-treatment if in Part B and clinically feasible
- Disease-free from active second or prior malignancies for at least 2 years
- Meet required laboratory test parameters
- 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)
- Heart disease classified as NYHA Level II or higher, recent myocardial infarction within 6 months, or unstable arrhythmia
- QTcF interval over 470 msec, congenital long QT syndrome, or significant ECG abnormalities
- Active, uncontrolled infections requiring systemic therapy within 7 days before first treatment
- Active autoimmune disease or medical conditions requiring chronic systemic steroids or immunosuppressants
- 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 diseases
- Pregnant or nursing women
- Major surgery within 28 days before first treatment dose
- Prior anticancer therapy within 4 weeks or 5 half-lives before first treatment dose, with exceptions
- History of severe allergic reactions to biologic therapy
- Radiation therapy for symptomatic lesions within 14 days before first dose
- Active substance abuse
- History of severe immune-related adverse events from prior cancer immunotherapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
2
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Actively Recruiting
3
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China, 200437
Actively Recruiting
Research Team
S
Shanghai Xunbaihui Biotechnology
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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