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.
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
1 other identifier
interventional
227
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2026
Typical duration for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 29, 2026
CompletedStudy Start
First participant enrolled
June 2, 2026
CompletedFirst Posted
Study publicly available on registry
June 3, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 15, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 15, 2029
June 8, 2026
June 1, 2026
2 years
May 29, 2026
June 4, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
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
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)
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)
Study Arms (1)
GV20-0251 + Anti-PD-1 Monoclonal Antibody Combination Therapy
EXPERIMENTALAll 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.
Interventions
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 antibodies 200 mg IV Q3W; C1D1 infusion ≥ 60 min, subsequent infusions may be shortened to ≥ 30 min; administered prior to GV20-0251.
Eligibility Criteria
You may qualify if:
- 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.
- 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.
- +3 more criteria
You may not qualify if:
- 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.
- 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
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081, China
Related Publications (1)
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.
PMID: 38657602BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 29, 2026
First Posted
June 3, 2026
Study Start
June 2, 2026
Primary Completion (Estimated)
June 15, 2028
Study Completion (Estimated)
August 15, 2029
Last Updated
June 8, 2026
Record last verified: 2026-06