Phase 1 Open-label Study of TRX518 Monotherapy and TRX518 in Combination With Gemcitabine, Pembrolizumab, or Nivolumab
Status:
Completed
Trial end date:
2020-07-14
Target enrollment:
Participant gender:
Summary
This study will be conducted in 5 parts (Parts A, B, C, D and E).
Monotherapy Treatment:
Subjects ≥18 years with advanced solid tumors will be enrolled in the study. Monotherapy dose
escalation will be performed in Part A. Cycle 1 data from each cohort will be evaluated for
safety and dose-limiting toxicities (DLTs) prior to dose escalation. Subjects will be
assigned to a cohort in the order screening is completed. Dose will depend upon the cohort in
which a patient is enrolled and cohorts will be dosed consecutively by ascending dose. Once
the maximum tolerated dose (MTD) or maximum administered dose (MAD) has been identified, an
expanded cohort will be enrolled (Part B).
Combination Treatment:
Subjects ≥18 years with advanced solid tumors will be enrolled in the study. Subjects will
receive TRX518 in combination with gemcitabine (Part C), pembrolizumab (Part D), or nivolumab
(Part E). Dose escalation will be performed for each part (Part Cesc, Part Desc, Part Eesc)
and Cycle 1 data from each cohort will be evaluated for safety and dose-limiting toxicities
(DLTs) prior to dose escalation. Subjects will be assigned to a cohort in the order screening
is completed. Dose will depend upon the cohort in which a patient is enrolled and cohorts
will be dosed consecutively by ascending dose. Once the maximum tolerated dose (MTD) or
maximum administered dose (MAD) has been identified, an expanded cohort will be enrolled
(Part Cexp, Part Dexp, Part Eexp).