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.

May 29, 2026 updated by: GV20 Therapeutics

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

227

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100142
        • Beijing Cancer Hospital
        • Sub-Investigator:
          • Jun Guo, MD
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150081
        • Harbin Medical University Cancer Hospital
        • Principal Investigator:
          • Tongsen Zheng, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

  1. Voluntarily signed written informed consent (ICF) prior to any study-specific procedures.
  2. Able and willing to participate in and comply with study procedures throughout the study.
  3. Age ≥ 18 and ≤ 80 years, any gender.
  4. Histologically confirmed unresectable, locally advanced, or metastatic solid tumor.
  5. 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.
  6. 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.
  7. 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).
  8. For certain tumor types, IGSF8 protein expression on the tumor cell membrane must be positive at pre-screening or screening.
  9. 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.
  10. 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.
  11. Must have at least one measurable lesion per RECIST v1.1. Previously irradiated lesions with documented progression may be considered measurable.
  12. 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.
  13. ECOG performance status of 0-1 prior to the first dose on C1D1.
  14. Expected survival ≥ 24 weeks.
  15. 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.
  16. Adequate organ, Hepatic, and Coagulation function at screening.
  17. 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.
  18. For HCC or biliary tract malignancy subjects only, as Child-Pugh Class A.

Exclusion Criteria

  1. 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.
  2. Insufficient washout period from prior systemic anticancer therapy before initiating GV20-0251 and anti-PD-1 therapy (C1D1)
  3. 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.
  4. Currently enrolled in a drug or device clinical trial; or received an investigational device or investigational drug within 4 weeks prior to C1D1.
  5. Diagnosed with immunodeficiency; or currently receiving chronic systemic corticosteroids (> 10 mg/day prednisone equivalent) or any other form of immunosuppressive therapy.
  6. 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.
  7. 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.
  8. 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.
  9. Acute leukemia or chronic lymphocytic leukemia (CLL).
  10. 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.
  11. Active infection requiring systemic treatment; or active, uncontrolled bacterial, viral, or fungal infection requiring systemic treatment within 7 days prior to C1D1.
  12. History of (non-infectious) pneumonitis/interstitial lung disease requiring steroid treatment, or current pneumonitis/interstitial lung disease.
  13. Active autoimmune disease requiring systemic treatment within 2 years prior to C1D1
  14. HIV infection.
  15. Active HBV or HCV infection
  16. Prior major organ transplantation
  17. Prior autologous or allogeneic bone marrow transplantation.
  18. Symptomatic primary CNS malignancy, CNS metastases, or leptomeningeal disease.
  19. 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.
  20. Received a live or attenuated vaccine within 30 days prior to the first dose.
  21. Requires treatment with interferon-α or related/similar agents within 3 weeks prior to C1D1 or during the entire study period.
  22. 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.
  23. 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.
  24. 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.
  25. Additional exclusion criteria that applicable to HCC or biliary tract malignancy subjects.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GV20-0251 + Anti-PD-1 Monoclonal Antibody Combination Therapy
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.
Drug: GV20-0251
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.
Drug: anti-PD-1 monoclonal antibodies
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the safety and tolerability of GV20-0251 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
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
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)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GV20 Therapeutics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 2, 2026

Primary Completion (Estimated)

June 15, 2028

Study Completion (Estimated)

August 15, 2029

Study Registration Dates

First Submitted

May 29, 2026

First Submitted That Met QC Criteria

May 29, 2026

First Posted (Actual)

June 3, 2026

Study Record Updates

Last Update Posted (Actual)

June 3, 2026

Last Update Submitted That Met QC Criteria

May 29, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GV20-0251-400

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Uterine Cervical Neoplasms

Clinical Trials on GV20-0251

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in El Salvador

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe