A Phase II Study of GV20-0251 in Combination With Anti-PD-1 Monoclonal Antibodies in Patients Wit… (NCT07623642) | Clinical Trial Compass
Not Yet RecruitingPhase 2
A Phase II Study of GV20-0251 in Combination With Anti-PD-1 Monoclonal Antibodies in Patients With Unresectable, Locally Advanced, or Metastatic Solid Tumors.
China227 participantsStarted 2026-06-02
Plain-language summary
This is a Phase 2 study of GV20-0251 in combination with anti-PD-1 monoclonal antibodies (including tislelizumab and toripalimab) for the treatment of participants with unresectable, locally advanced, or metastatic solid tumors who are refractory to, intolerant of, or ineligible for standard of care.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Voluntarily signed written informed consent (ICF) prior to any study-specific procedures.
. Able and willing to participate in and comply with study procedures throughout the study.
. Age ≥ 18 and ≤ 80 years, any gender.
. Histologically confirmed unresectable, locally advanced, or metastatic solid tumor.
. Must have failed standard of care (SOC), be intolerant to SOC, or be deemed by the investigator to be unsuitable for a specific form of SOC. If SOC failure, documented progression from SOC is required.
. No more than 2 prior lines of systemic therapy. Subjects with more lines may be enrolled after sponsor approval. Treatment-naive subjects with locally advanced or metastatic melanoma who have not received systemic therapy may enroll.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is still listed as 'not yet recruiting' — do you know when it might open, and is there a way to get on a waiting list so we don't miss the enrollment window?
2Since this is a Phase II study combining an experimental drug called GV20-0251 with an anti-PD-1 immunotherapy, what is actually known so far about the safety of GV20-0251, and how does the risk profile compare to the standard treatments available for my specific cancer type?
3One of the main things this trial is measuring is the rate of dose-limiting toxicities — meaning serious side effects that could require reducing or stopping the drug — so how does that possibility factor into my overall treatment plan, and what would we do if I experienced one of those?
4My cancer type is one of several being studied in this trial — does being in a study that covers so many different tumor types affect how closely the treatment would be tailored to my specific diagnosis, and does it change how the results would apply to me?
5Before considering a combination immunotherapy trial like this one, should I first try any standard approved treatments for my cancer, or is there a reason it might make more sense to explore this trial now?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of Dose-Limiting Toxicities (DLTs) and Treatment-Emergent Adverse Events (TEAEs) in Combination with Anti-PD-1 Monoclonal Antibody
Timeframe: From Cycle 1 Day 1 dosing (each cycle is 21 days) through 30 days after end of treatment, up to 24 months
2
Evaluate the anti-tumor activity of GV20-0251 in combination with anti-PD-1 monoclonal antibody
Timeframe: 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)
. Tumor types include: endometrial cancer, cervical cancer, ovarian cancer, triple-negative breast cancer, prostate cancer, head and neck squamous cell carcinoma, esophageal squamous cell carcinoma, hepatocellular carcinoma (HCC), biliary tract malignancies (including only intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer; excluding ampullary carcinoma), pMMR/MSS colorectal adenocarcinoma, pancreatic ductal adenocarcinoma, non-small cell lung cancer (NSCLC), small cell lung cancer, and melanoma (assessed per local institutional standard practice).
. For certain tumor types, IGSF8 protein expression on the tumor cell membrane must be positive at pre-screening or screening.
Exclusion criteria
. Prior immunotherapy discontinued due to ≥ Grade 3 immune-related adverse events (irAEs) - except endocrine disorders manageable with replacement therapy or asymptomatic elevated serum amylase/lipase - Grade 2 myocarditis, or recurrent Grade 2 pneumonitis.
. Insufficient washout period from prior systemic anticancer therapy before initiating GV20-0251 and anti-PD-1 therapy (C1D1)
. Received radiotherapy within 2 weeks prior to initiating GV20-0251 and anti-PD-1 therapy, or has radiation-related toxicity requiring corticosteroids. For NSCLC subjects: pulmonary radiotherapy \> 30 Gy within 6 months prior to C1D1.
. Currently enrolled in a drug or device clinical trial; or received an investigational device or investigational drug within 4 weeks prior to C1D1.
. Diagnosed with immunodeficiency; or currently receiving chronic systemic corticosteroids (\> 10 mg/day prednisone equivalent) or any other form of immunosuppressive therapy.
. History of gastrointestinal perforation and/or fistula within 6 months prior to consent; or active gastric/duodenal ulcer, ulcerative colitis, or other GI conditions the investigator believes may cause bleeding or perforation.
. Clinically significant and/or uncontrolled cardiac disease, including NYHA Class III or IV heart failure, uncontrolled hypertension (systolic BP \> 160 mmHg), clinically significant arrhythmia assessed by the investigator to affect study participation safety, or myocardial infarction within 6 months prior to C1D1.
. Severe hypersensitivity reaction (≥ Grade 3) to anti-PD-1 monoclonal antibody and/or any of its excipients; or prior severe hypersensitivity to biologic therapies that the investigator considers may increase subject risk.