Uterine Cervical NeoplasmsPhase 2NCT07623642
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.
A Phase 2 study testing GV20-0251 and anti-PD-1 monoclonal antibodies in people with Uterine Cervical Neoplasms and Triple Negative Breast Neoplasms, run by GV20 Therapeutics at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Uterine Cervical Neoplasms, Triple Negative Breast Neoplasms, Prostatic Neoplasms
- What is being tested?
- GV20-0251 and anti-PD-1 monoclonal antibodies
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 227 participants
- Where
- 2 sitesChina
- Study dates
- 2 Jun 2026to 15 Aug 2029
- Phase
- Phase 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
- If the subject has received prior anti-PD-1/PD-L1 therapy, documented disease progression during treatment with anti-PD-1/PD-L1 monoclonal antibody (as monotherapy or combined with other checkpoint inhibitors/therapies) is required.
- Eligible subjects of childbearing potential (female and male) must agree to use effective contraception (hormonal or barrier method) starting 28 days prior to the first dose of GV20-0251, throughout the treatment period, and for at least 4 months after the last dose.
- Must have at least one measurable lesion per RECIST v1.1. Previously irradiated lesions with documented progression may be considered measurable.
- Must provide archival tumor tissue collected within 3 years prior to signing the ICF. If archival tissue is >3 years old, enrollment requires medical confirmation with the sponsor.
- ECOG performance status of 0-1 prior to the first dose on C1D1.
- Expected survival ≥ 24 weeks.
- No history of other primary malignancies, except: (a) a curatively treated malignancy with no active disease for at least 2 years prior to consent and low risk of subsequent relapse; or (b) curatively treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or carcinoma in situ of the breast.
- Adequate organ, Hepatic, and Coagulation function at screening.
- All adverse events related to prior anticancer therapy have resolved to ≤ Grade 1 (per NCI CTCAE v5.0). For persistent Grade 2 toxicities deemed by the investigator unlikely to resolve, eligibility may be discussed with the sponsor.
- For HCC or biliary tract malignancy subjects only, as Child-Pugh Class A.
Who cannot join
- 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.
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- 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.
- Acute leukemia or chronic lymphocytic leukemia (CLL).
- QTcF > 470 msec, or history of congenital long QT syndrome, or clinically significant ECG abnormalities (including pericarditis) that the investigator considers may affect subject safety.
- Active infection requiring systemic treatment; or active, uncontrolled bacterial, viral, or fungal infection requiring systemic treatment within 7 days prior to C1D1.
- History of (non-infectious) pneumonitis/interstitial lung disease requiring steroid treatment, or current pneumonitis/interstitial lung disease.
- Active autoimmune disease requiring systemic treatment within 2 years prior to C1D1
- HIV infection.
- Active HBV or HCV infection
- Prior major organ transplantation
- Prior autologous or allogeneic bone marrow transplantation.
- Symptomatic primary CNS malignancy, CNS metastases, or leptomeningeal disease.
- Major surgery (excluding diagnostic procedures) or severe trauma within 28 days prior to the first dose of GV20-0251, or currently in recovery that the investigator deems would interfere with the study, or anticipated major surgery during the study.
- Received a live or attenuated vaccine within 30 days prior to the first dose.
- Requires treatment with interferon-α or related/similar agents within 3 weeks prior to C1D1 or during the entire study period.
- Requires more than one paracentesis per 8 weeks to manage ascites; or single ascites drainage volume > 1.5 liters within 8 weeks prior to C1D1.
- Psychiatric illness or substance abuse disorder (e.g., drug abuse, alcohol dependence) that may interfere with the subject's ability to comply with study requirements.
- Other serious non-malignant conditions or laboratory abnormalities that, in the opinion of the investigator and/or sponsor, make the subject unsuitable for the study; or other circumstances that the investigator believes may confound study results or prevent the subject from completing the study.
- Additional exclusion criteria that applicable to HCC or biliary tract malignancy subjects.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Jun Guo, MD
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081
Tongsen Zheng, MD
About this study
Official title: An Open-Label, Multicenter, Non-Randomized, Phase II Study of GV20-0251 in Combination With Anti-PD-1 Monoclonal Antibodies in Patients With Unresectable, Locally Advanced, or Metastatic Solid Tumors
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.
- Conditions
- Uterine Cervical Neoplasms, Triple Negative Breast Neoplasms, Prostatic Neoplasms, Squamous Cell Carcinoma of Head and Neck, Esophageal Squamous Cell Carcinoma, Cholangiocarcinoma
- Being tested
- GV20-0251, anti-PD-1 monoclonal antibodies
- Medical subject headings
- Uterine Cervical Neoplasms, Triple Negative Breast Neoplasms, Prostatic Neoplasms, Squamous Cell Carcinoma of Head and Neck, Esophageal Squamous Cell Carcinoma, Cholangiocarcinoma, Gallbladder Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GV20-0251Drug
GV20-0251 10/20 mg/kg or SRC-recommended dose in combination with anti-PD-1, Q3W; Part B: RP2D + standard dose anti-PD-1, Q3W.
anti-PD-1 monoclonal antibodiesDrug
anti-PD-1 monoclonal antibodies 200 mg IV Q3W; C1D1 infusion ≥ 60 min, subsequent infusions may be shortened to ≥ 30 min; administered prior to GV20-0251.
| Study group | Role | What they receive |
|---|---|---|
| GV20-0251 + Anti-PD-1 Monoclonal Antibody Combination Therapy | Experimental | All participants receive GV20-0251 by intravenous (IV) infusion every 3 weeks (Q3W) in combination with anti-PD-1 monoclonal antibodies 200 mg IV Q3W. In Part A (Safety Bridging), GV20-0251 is administered at 10 mg/kg, 20 mg/kg, or an alternative SRC-determined dose in sequential dose cohorts to determine the Recommended Phase 2 Dose (RP2D). In Part B (Phase 2 Pivotal), GV20-0251 is administered at the RP2D across multiple tumor-type cohorts. Receives: Drug: GV20-0251; Drug: anti-PD-1 monoclonal antibodies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Dose-Limiting Toxicities (DLTs) and Treatment-Emergent Adverse Events (TEAEs) in Combination with Anti-PD-1 Monoclonal Antibody
Incidence of dose-limiting toxicities (DLTs) and treatment-emergent adverse events (TEAEs) assessed by NCI CTCAE v5.0
Measured: From Cycle 1 Day 1 dosing (each cycle is 21 days) through 30 days after end of treatment, up to 24 months
Evaluate the anti-tumor activity of GV20-0251 in combination with anti-PD-1 monoclonal antibody
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 posted3 Jun 2026
- Study start2 Jun 2026 (estimated)
- Primary completion15 Jun 2028 (estimated)
- Study completion15 Aug 2029 (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 Uterine Cervical NeoplasmsStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 227 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
- NCT07623642
- Sponsor's protocol ID
- GV20-0251-400
- Status last verified
- Jun 2026
- First submitted
- 29 May 2026
- Last updated
- 8 Jun 2026
- 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 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multicenter, Non-Randomized, Phase II Study of GV20-0251 in Combination With Anti-PD-1 Monoclonal Antibodies in Patients With Unresectable, Locally Advanced, or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT07623642
- Acronym / sponsor ID
- GV20-0251-400
- Conditions
- Uterine Cervical Neoplasms, Triple Negative Breast Neoplasms, Prostatic Neoplasms, Squamous Cell Carcinoma of Head and Neck, Esophageal Squamous Cell Carcinoma, Cholangiocarcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 227 participants (estimated)
- Lead sponsor
- GV20 TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 2 Jun 2026 (estimated)
- Primary completion
- 15 Jun 2028 (estimated)
- Study completion
- 15 Aug 2029 (estimated)
- First posted
- 3 Jun 2026 (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 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.
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 + Anti-PD-1 Monoclonal Antibody Combination Therapy | Experimental | Drug: GV20-0251, Drug: anti-PD-1 monoclonal antibodiesAll participants receive GV20-0251 by intravenous (IV) infusion every 3 weeks (Q3W) in combination with anti-PD-1 monoclonal antibodies 200 mg IV Q3W. In Part A (Safety Bridging), GV20-0251 is administered at 10 mg/kg, 20 mg/kg, or an alternative SRC-determined dose in sequential dose cohorts to determine the Recommended Phase 2 Dose (RP2D). In Part B (Phase 2 Pivotal), GV20-0251 is administered at the RP2D across multiple tumor-type cohorts. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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.
Key exclusion criteria (25 listed)
- 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.
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 |
|---|---|---|
| GV20-0251GV20-0251 10/20 mg/kg or SRC-recommended dose in combination with anti-PD-1, Q3W; Part B: RP2D + standard dose anti-PD-1, Q3W. | Drug | GV20-0251 + Anti-PD-1 Monoclonal Antibody Combination Therapy |
| anti-PD-1 monoclonal antibodiesanti-PD-1 monoclonal antibodies 200 mg IV Q3W; C1D1 infusion ≥ 60 min, subsequent infusions may be shortened to ≥ 30 min; administered prior to GV20-0251. | Drug | GV20-0251 + Anti-PD-1 Monoclonal Antibody Combination Therapy |
Primary outcome
Incidence of Dose-Limiting Toxicities (DLTs) and Treatment-Emergent Adverse Events (TEAEs) in Combination with Anti-PD-1 Monoclonal Antibody
Time frame: From Cycle 1 Day 1 dosing (each cycle is 21 days) through 30 days after end of treatment, up to 24 months
Incidence of dose-limiting toxicities (DLTs) and treatment-emergent adverse events (TEAEs) assessed by NCI CTCAE v5.0
Evaluate the anti-tumor activity of GV20-0251 in combination with anti-PD-1 monoclonal antibody
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 8 Jun 2026.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GV20-0251 and anti-PD-1 monoclonal antibodies in people with Uterine Cervical Neoplasms and Triple Negative Breast Neoplasms, run by GV20 Therapeutics at 2 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 18 inclusion and 25 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: opening soon, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 phase mean?
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?
Incidence of Dose-Limiting Toxicities (DLTs) and Treatment-Emergent Adverse Events (TEAEs) in Combination with Anti-PD-1 Monoclonal Antibody (time frame: From Cycle 1 Day 1 dosing (each cycle is 21 days) through 30 days after end of treatment, up to 24 months). The study lists 2 primary outcomes in all. 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 NCT07623642, 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 8 Jun 2026.