A Study of GV20-0251 in Patients With Solid Tumor Malignancies

• Status: Not yet recruiting
• Trial end date: 2024-12-15
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase 1 study of GV20-0251 being developed for the treatment of patients with advanced solid tumors, who are refractory to approved therapies or other standard of care.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GV20 Therapeutics

Criteria

Inclusion Criteria:

• >= 18 years of age

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

• refractory or intolerant to standard therapy(ies)

• one or more metastatic solid tumors that are evaluable or measurable per RECIST v1.1

• ECOG performance status of 0 or 1

• Life expectancy of >=12 weeks

• Disease-free of active second/secondary or prior malignancies for ≥ 2 years

• laboratory test results within the required parameters

• Women of child bearing potential (WOCBP) and men must agree to use adequate contraception

Exclusion Criteria:

• Patients with hematologic malignancies

• Patients with heart disease or unstable arrhythmia

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

• Known human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C infection

• History of major organ transplant

• History of a bone marrow transplant

• Symptomatic central nervous system (CNS) malignancy or metastasis

• Serious nonmalignant disease

• Pregnant or nursing women

• Treatment with PD-1 and equivalent immune modulators or major surgery prior to the first dose of study medication

• Patients who are currently receiving any other investigational agent or have received an investigational agent within 4 weeks prior to the first dose of study medication

• Treatment with any anticancer treatments with 2-weeks prior to the first dose of study medication

• Radiation for symptomatic lesions must have been completed prior to the first dose of study medication

• Active substance abuse