Solid Tumor CancerPhase 1/2NCT07070518
Study of GV20-0251 in Participants With Solid Tumor Malignancies
A Phase 1/2 study testing GV20-0251 in people with Solid Tumor Cancer and Adult Refractory Cancer, run by GV20 Therapeutics at 3 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor Cancer, Adult Refractory Cancer, Endometrial Carcinoma (EC)
- 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
- 350 participants
- Where
- 3 sitesChina
- Study dates
- 11 Jul 2025to 16 Sep 2028
- Phase
- Phase 1/2
- 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)
- 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
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- 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
Who cannot join
- 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.
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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
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Shanghai Xunbaihui Biotechnology, clinicaltrials@gv20tx.com
Jun Guo, MD
- Recruiting
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality
- Recruiting
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200437
Peng Zhang, MD
Dongliang Bian, MD
About this study
Official title: An Open-Label Phase 1/2A Study of GV20-0251 in Participants With Advanced and/or Refractory Solid Tumor Malignancies
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.
Read the detailed description
This is a Phase 1/2A non-randomized, open-label, multi-center study to be conducted in 2 parts (A and B).
Part A is a safety run-in portion. A 3+3 dose escalation scheme will be used to evaluate the safety and tolerability of GV20-0251, and to establish the maximum tolerated dose (MTD) or the preliminary recommended Phase 2 dose (RP2D).
In Part B, the Simon 2-stage design will be utilized to further characterize the anti-tumor activities, safety, tolerability, pharmacokinetics, and pharmacodynamics of GV20-0251 at the preliminary RP2D across multiple expansion cohorts involving eligible participants.
- Conditions
- Solid Tumor Cancer, Adult Refractory Cancer, Endometrial Carcinoma (EC), Squamous Head and Neck Carcinoma, pMMR/MSS Adenocarcinoma of the Colon or Rectum, Non-Small Cell Lung Cancer
- Being tested
- GV20-0251
- Medical subject headings
- Neoplasms, Endometrial Neoplasms, Carcinoma, Non-Small-Cell Lung, Melanoma, Carcinoma, Hepatocellular, Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GV20-0251Drug
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
| Study group | Role | What they receive |
|---|---|---|
| GV20-0251 | Experimental | Not described Receives: Drug: GV20-0251 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2025
- Study start11 Jul 2025
- Primary completion16 Jul 2027 (estimated)
- Study completion16 Sep 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 Solid Tumor CancerStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GV20 Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07070518
- Sponsor's protocol ID
- GV20-0251-300
- Status last verified
- Dec 2025
- First submitted
- 26 Jun 2025
- Last updated
- 3 Dec 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 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Phase 1/2A Study of GV20-0251 in Participants With Advanced and/or Refractory Solid Tumor Malignancies
- ClinicalTrials.gov ID
- NCT07070518
- Acronym / sponsor ID
- GV20-0251-300
- Conditions
- Solid Tumor Cancer, Adult Refractory Cancer, Endometrial Carcinoma (EC), Squamous Head and Neck Carcinoma, pMMR/MSS Adenocarcinoma of the Colon or Rectum, Non-Small Cell Lung Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- GV20 TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 11 Jul 2025 (actual)
- Primary completion
- 16 Jul 2027 (estimated)
- Study completion
- 16 Sep 2028 (estimated)
- First posted
- 17 Jul 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 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.
Detailed description
This is a Phase 1/2A non-randomized, open-label, multi-center study to be conducted in 2 parts (A and B).
Part A is a safety run-in portion. A 3+3 dose escalation scheme will be used to evaluate the safety and tolerability of GV20-0251, and to establish the maximum tolerated dose (MTD) or the preliminary recommended Phase 2 dose (RP2D).
In Part B, the Simon 2-stage design will be utilized to further characterize the anti-tumor activities, safety, tolerability, pharmacokinetics, and pharmacodynamics of GV20-0251 at the preliminary RP2D across multiple expansion cohorts involving eligible participants.
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 | Experimental | Drug: GV20-0251 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 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)
- Participants must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST version 1.1)
Key exclusion criteria (16 listed)
- 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
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 |
|---|---|---|
| GV20-0251Part 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 | Drug | GV20-0251 |
Primary outcome
Evaluate anti-tumor activities with GV20-0251
Time frame: 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)
Objective Response Rate (ORR) assessed by RECIST v1.1 (Response Evaluation Criteria in Solid Tumors, Version 1.1)
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 3 Dec 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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing GV20-0251 in people with Solid Tumor Cancer and Adult Refractory Cancer, run by GV20 Therapeutics at 3 sites 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 10 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 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Shanghai Xunbaihui Biotechnology (+8615800557307, clinicaltrials@gv20tx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate anti-tumor activities with GV20-0251 (time frame: 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)). 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 NCT07070518, 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 3 Dec 2025; AzTrials last refreshed its copy on 26 Oct 2026.