Health Trials

About this trial

This is a Phase 1/2A 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.

Eligibility criteria

Qualifiers

Participants ≥18 years of age

Previously treated, histologically-confirmed advanced solid malignancy with progressive disease requiring therapy

Refractory or intolerant to standard therapy(ies)

Must have received, be not eligible or decline standard of care therapy

Disqualifiers

Participant with acute leukemia or CLL (Parts A and B only)

Participant with heart disease or unstable arrhythmia

Active, uncontrolled bacterial, viral, or fungal infections requiring systemic therapy

Participant has active autoimmune disease or other medical conditions requiring chronic systemic steroid or immunosuppressive therapy

Trial design

Treatments tested in this trial

  • GV20-0251
  • GV20-0251
  • GV20-0251 and Pembrolizumab [KEYTRUDA®]
  • GV20-0251 and Pembrolizumab [KEYTRUDA®]

Treatment groups

365 Participants
are divided into 4 treatment groups

Locations

13
California
The Angeles Clinic and Research Institute90025, Los Angeles United States
Colorado
HealthONE Clinic Services Oncology - Hematology, LLC d/b/a Sarah Cannon Research Institute at HealthONE80218, Denver United States
Connecticut
Yale University06511, New Haven United States
Florida
Florida Cancer Specialists & Research Institute, LLC33916, Fort Myers United States

Sponsors and collaborators

GV20 Therapeutics

Lead sponsor

Merck Sharp & Dohme LLC

Collaborator

Source ClinicalTrials.gov