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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.
Full 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.
Enrollment
Sex
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Volunteers
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)
Must have received, be not eligible or decline standard of care therapy
One or more metastatic solid tumors that are evaluable or measurable per RECIST v1.1
For participants who have received prior treatment with a checkpoint inhibitor there must be documented disease progression
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
Part B ONLY must include the following tumor types:
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
268 participants in 2 patient groups
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Central trial contact
GV20 Therapeutics
Data sourced from clinicaltrials.gov
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