Health Trials

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.

ConditionsUterine Cervical NeoplasmsTriple Negative Breast NeoplasmsProstatic NeoplasmsSquamous Cell Carcinoma of Head and NeckEsophageal Squamous Cell CarcinomaCholangiocarcinomaGallbladder NeoplasmsColorectal NeoplasmsPancreatic Ductal AdenocarcinomaCarcinoma, Non-Small-Cell LungSmall Cell Lung Carcinoma
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorGV20 Therapeutics

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • GV20-0251
  • anti-PD-1 monoclonal antibodies

Treatment groups

227 Participants
are divided into 1 treatment group

Locations

2
Beijing Cancer Hospital100142, BeijingBeijing Municipality, China
Harbin Medical University Cancer Hospital150081, HarbinHeilongjiang, China

Sponsors and collaborators

GV20 Therapeutics

Lead sponsor

Source ClinicalTrials.gov