NCT02628574

Phase 1 Open-label Study of TRX518 Monotherapy and TRX518 in Combination With Gemcitabine, Pembrolizumab, or Nivolumab

A Phase 1 Study of TRX518 Monotherapy and TRX518 in Combination With Gemcitabine, Pembrolizumab, or Nivolumab in Adults With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 109 (actual)
• Sponsor: Leap Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Solid Tumors

Interventions

Type	Name	Description
DRUG	TRX518 monotherapy	comparison of different (ascending) doses of TRX518 monotherapy
DRUG	TRX518 with gemcitabine	comparison of different (ascending) doses of TRX518 in combination with gemcitabine
DRUG	TRX518 with pembrolizumab	comparison of different (ascending) doses of TRX518 in combination with pembrolizumab
DRUG	TRX518 with nivolumab	comparison of different (ascending) doses of TRX518 in combination with nivolumab

Timeline

• Start date: 2016-01-01
• Primary completion: 2020-07-14
• Completion: 2020-07-14
• First posted: 2015-12-11
• Last updated: 2025-08-03

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study