Spots Global Cancer Trial Database for A Study of GV20-0251 in Patients With Solid Tumor Malignancies

Study Description

Brief Summary: This is a Phase 1 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.

Detailed Description: This is a Phase 1 non-randomized, open label, multi-center study to be conducted in two parts (Parts A and B). Part A involves a 3 + 3 dose escalation scheme to evaluate safety and dose limiting toxicities and to establish the maximum tolerated dose and/or the recommended Phase 2 dose of GV20-0251. Part B consists of multiple expansion cohorts in which eligible participants will be treated at the recommended Phase 2 dose of GV20-0251 to further characterize the safety, tolerability, pharmacokinetics and pharmacodynamics of GV20-0251 as well as to evaluate anti-tumor activity in patients with selected malignancies. The study consists of a Screening Period, a Treatment Period, an End of Treatment Visit, Safety Follow-Up Period and a Survival Follow-Up Period.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

Useful links and downloads for this trial