Study of GV20-0251 in Participants With Solid Tumor Malignancies
An Open-Label Phase 1/2A Study of GV20-0251 in Participants With Advanced and/or Refractory Solid Tumor Malignancies
1 other identifier
interventional
350
1 country
3
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jul 2025
Typical duration for phase_1
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 26, 2025
CompletedStudy Start
First participant enrolled
July 11, 2025
CompletedFirst Posted
Study publicly available on registry
July 17, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 16, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 16, 2028
December 3, 2025
December 1, 2025
2 years
June 26, 2025
December 1, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Evaluate anti-tumor activities with GV20-0251
Objective Response Rate (ORR) assessed by RECIST v1.1 (Response Evaluation Criteria in Solid Tumors, Version 1.1)
From Cycle 1 Day 1 dosing (each cycle is 21 days) until disease progression or end of study (whichever occurs first, up to 24 months)
Study Arms (1)
GV20-0251
EXPERIMENTALInterventions
Part A: Increasing doses of GV20-0251 administered by intravenous (IV) infusion once every 3 weeks Part B: GV20-0251 preliminary RP2D administered by IV infusion once every 3 weeks
Eligibility Criteria
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)
- Participants must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST version 1.1)
- For participants who have received prior treatment with a checkpoint inhibitor there must be documented disease progression
- ECOG performance status of 0 or 1 before C1D1
- Part B Participants must be willing to provide fresh tumor biopsy (core biopsy) both pre-treatment and on-treatment, if clinically feasible
- 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 (NYHA ≥ Level II), 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 before 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142, China
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200437, China
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: 38657602BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 26, 2025
First Posted
July 17, 2025
Study Start
July 11, 2025
Primary Completion (Estimated)
July 16, 2027
Study Completion (Estimated)
September 16, 2028
Last Updated
December 3, 2025
Record last verified: 2025-12