HCC - Hepatocellular CarcinomaPhase 1NCT07106827
A Study of GV20-0251 in Advanced or Refractory Solid Tumors
A Phase 1 study testing GV20-0251 in people with HCC - Hepatocellular Carcinoma and Cholangiocarcinoma, run by West China Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HCC - Hepatocellular Carcinoma, Cholangiocarcinoma, Melanoma
- What is being tested?
- GV20-0251
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 4 Sep 2025to 11 Jun 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
- ECOG performance status of 0 or 1 before C1D1
- 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
Who cannot join
- 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)
- 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.
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
West China Hospital
Chengdu, Sichuan
Jin Zhou, +8618980600172, zhoujin096@scu.edu.cn
zhoujin096@scu.edu.cn
About this study
Official title: Single Arm Clinical Study Protocol of GV20-0251 in the Treatment of Advanced/Refractory Solid Tumors
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.
Read the detailed description
Standard Phase I clinical trial (dose escalation test) 3 + 3 study method was used: the initial dose group 1 was 10 mg/kg (Q3W) and 20 mg/kg (Q3W) for dose group 2. If the MDT is not reached at dose group 2, no further dose escalation will be conducted. Three individuals were enrolled first at each dose level. If none of the three patients developed DLT during treatment (DLT observation period of 21 days), the trial entered the next dose group. Otherwise, when 1 out of 3 subjects experiences DLT, an additional 3 subjects should be enrolled in this dose group. If only 1 out of 6 patients experienced DLT, the trial continued to the next dose level. If ≥ 2 out of 3 or ≥ 2 out of 6 patients experience a DLT, enrollment will not continue to increase. If the first 3 participants cannot tolerate this dose level, a lower dose or regimen may be used after approval by the site's Clinical Trial Committee. The following oncologic indications will be assessed in this study: hepatocellular carcinoma (HCC), cholangiocarcinoma, uveal melanoma, non-uveal melanoma, non-small cell lung cancer (NSCLC), pancreatic ductal adenocarcinoma, head and neck squamous cell carcinoma (HNSCC), endometrial cancer, and testicular cancer. Additional indications may be evaluated, including CRC, clear cell renal cell carcinoma, gastric or gastroesophageal junction carcinoma, sarcoma carcinoma, breast cancer, prostate cancer, cervical cancer, and small cell lung cancer. (The method of drug infusion and detailed drug-related instructions are provided in the Annex of the Investigational Drug Instruction Manual).
Screening period:
- From the day the subject signed the informed consent form to the day before the first dose of the investigational product (Day 1),
- The screening period does not exceed 28 days (Day-28 to Day-1);
Treatment Period and Efficacy Evaluation:
Eligible participants entered the treatment phase, and the investigator calculated the administered dose and drug concentration of GV20-0251 based on the patient's body weight, thereby calculating the required GV20-0251 drug volume and the corresponding number of bottles. The study nurse will remove the bottle from the refrigerator and bring it to room temperature, which will take approximately 30-60 minutes. GV20-0251 solution for intravenous infusion is formulated from GV20-0251 injection and 0.9% sodium chloride injection in a saline bag volume of 250 mL depending on the amount of GV20-0251 injection administered. GV20-0251 Injection will be administered to eligible subjects by a research nurse under the supervision of study personnel.
- Conditions
- HCC - Hepatocellular Carcinoma, Cholangiocarcinoma, Melanoma, NSCLC (Non-small Cell Lung Cancer), Pancreatic Ductal Adenocarcinoma, HNSCC
- Being tested
- GV20-0251
- Keywords
- GV20-0251
- Medical subject headings
- Carcinoma, Hepatocellular, Cholangiocarcinoma, Melanoma, Carcinoma, Non-Small-Cell Lung, Squamous Cell Carcinoma of Head and Neck, Endometrial Neoplasms, Testicular Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GV20-0251Drug
Increasing doses of GV20-0251 administered by intravenous (IV) infusion once every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| GV20-0251 Treatment | Experimental | GV20-0251 safety in Advanced/Refractory Solid Tumors Receives: Drug: GV20-0251 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate GV20-0251 safety
Safety should be evaluated according to CTCAE5.0
Measured: From Cycle 1 Day 1 dosing (each cycle is 21 days) until meeting the study termination criteria or 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study start4 Sep 2025
- Primary completion11 Jun 2027 (estimated)
- Study completion11 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HCC - Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- GV20 Therapeutics
- Responsible party
- Principal investigator, Xingchen Peng, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07106827
- Sponsor's protocol ID
- 2025-852
- Status last verified
- Nov 2025
- First submitted
- 9 Jul 2025
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 38657602
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Arm Clinical Study Protocol of GV20-0251 in the Treatment of Advanced/Refractory Solid Tumors
- ClinicalTrials.gov ID
- NCT07106827
- Acronym / sponsor ID
- 2025-852
- Conditions
- HCC - Hepatocellular Carcinoma, Cholangiocarcinoma, Melanoma, NSCLC (Non-small Cell Lung Cancer), Pancreatic Ductal Adenocarcinoma, HNSCC
- Keywords
- GV20-0251
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Collaborators
- GV20 Therapeutics
- Study start
- 4 Sep 2025 (actual)
- Primary completion
- 11 Jun 2027 (estimated)
- Study completion
- 11 Jun 2028 (estimated)
- First posted
- 6 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Standard Phase I clinical trial (dose escalation test) 3 + 3 study method was used: the initial dose group 1 was 10 mg/kg (Q3W) and 20 mg/kg (Q3W) for dose group 2. If the MDT is not reached at dose group 2, no further dose escalation will be conducted. Three individuals were enrolled first at each dose level. If none of the three patients developed DLT during treatment (DLT observation period of 21 days), the trial entered the next dose group. Otherwise, when 1 out of 3 subjects experiences DLT, an additional 3 subjects should be enrolled in this dose group. If only 1 out of 6 patients experienced DLT, the trial continued to the next dose level. If ≥ 2 out of 3 or ≥ 2 out of 6 patients experience a DLT, enrollment will not continue to increase. If the first 3 participants cannot tolerate this dose level, a lower dose or regimen may be used after approval by the site's Clinical Trial Committee. The following oncologic indications will be assessed in this study: hepatocellular carcinoma (HCC), cholangiocarcinoma, uveal melanoma, non-uveal melanoma, non-small cell lung cancer (NSCLC), pancreatic ductal adenocarcinoma, head and neck squamous cell carcinoma (HNSCC), endometrial cancer, and testicular cancer. Additional indications may be evaluated, including CRC, clear cell renal cell carcinoma, gastric or gastroesophageal junction carcinoma, sarcoma carcinoma, breast cancer, prostate cancer, cervical cancer, and small cell lung cancer. (The method of drug infusion and detailed drug-related instructions are provided in the Annex of the Investigational Drug Instruction Manual).
Screening period:
- From the day the subject signed the informed consent form to the day before the first dose of the investigational product (Day 1),
- The screening period does not exceed 28 days (Day-28 to Day-1);
Treatment Period and Efficacy Evaluation:
Eligible participants entered the treatment phase, and the investigator calculated the administered dose and drug concentration of GV20-0251 based on the patient's body weight, thereby calculating the required GV20-0251 drug volume and the corresponding number of bottles. The study nurse will remove the bottle from the refrigerator and bring it to room temperature, which will take approximately 30-60 minutes. GV20-0251 solution for intravenous infusion is formulated from GV20-0251 injection and 0.9% sodium chloride injection in a saline bag volume of 250 mL depending on the amount of GV20-0251 injection administered. GV20-0251 Injection will be administered to eligible subjects by a research nurse under the supervision of study personnel.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GV20-0251 Treatment | Experimental | Drug: GV20-0251GV20-0251 safety in Advanced/Refractory Solid Tumors |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
- ECOG performance status of 0 or 1 before C1D1
Key exclusion criteria (16 listed)
- 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)
- Participant has active autoimmune disease or other medical conditions requiring chronic systemic steroid or immunosuppressive therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GV20-0251Increasing doses of GV20-0251 administered by intravenous (IV) infusion once every 3 weeks | Drug | GV20-0251 Treatment |
Primary outcome
Evaluate GV20-0251 safety
Time frame: From Cycle 1 Day 1 dosing (each cycle is 21 days) until meeting the study termination criteria or 2 years
Safety should be evaluated according to CTCAE5.0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- Background: PubMed 38657602Li 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GV20-0251 in people with HCC - Hepatocellular Carcinoma and Cholangiocarcinoma, run by West China Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jin Zhou (+8618980600172, zhoujin096@scu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate GV20-0251 safety (time frame: From Cycle 1 Day 1 dosing (each cycle is 21 days) until meeting the study termination criteria or 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07106827, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025.