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New treatment option for Solid Tumor Cancer
Official title Study of GV20-0251 in Participants With Solid Tumor Malignancies
ClinicalTrials.gov ID: NCT07070518
What this study is testing
What is GV20-0251?
GV20-0251 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for solid tumor cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- Participants must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST version 1.1)
You likely can't join 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...
- 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...
See the full eligibility criteria
- 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
- 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...
- 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
- Any history of an immune-related ≥ Grade 3 AE attributed to prior cancer immunotherapy
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.