Study of GV20-0251 in Participants With Solid Tumor Malignancies

December 1, 2025 updated by: GV20 Therapeutics

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

350

Phase

  • Phase 2
  • Phase 1

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
        • Recruiting
        • Beijing Cancer Hospital
        • Sub-Investigator:
          • Lu Si, MD
        • Principal Investigator:
          • Jun Guo, MD
        • Contact:
      • Beijing, Beijing Municipality, China
        • Recruiting
        • Cancer Hospital, Chinese Academy of Medical Sciences
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200437
        • Recruiting
        • Shanghai Pulmonary Hospital
        • Principal Investigator:
          • Peng Zhang, MD
        • Sub-Investigator:
          • Dongliang Bian, 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:

  • 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
  • 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

Exclusion Criteria:

  • 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.
  • 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

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
Drug: GV20-0251
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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 (Actual)

July 11, 2025

Primary Completion (Estimated)

July 16, 2027

Study Completion (Estimated)

September 16, 2028

Study Registration Dates

First Submitted

June 26, 2025

First Submitted That Met QC Criteria

July 16, 2025

First Posted (Actual)

July 17, 2025

Study Record Updates

Last Update Posted (Estimated)

December 3, 2025

Last Update Submitted That Met QC Criteria

December 1, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GV20-0251-300

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

product manufactured in and exported from the U.S.

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.

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