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

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Leap Therapeutics, Inc.
Study ID
NCT02628574
Phase
PHASE1
Status
Completed

Conditions

  • Solid Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • TRX518 monotherapy — DRUG
    comparison of different (ascending) doses of TRX518 monotherapy
  • TRX518 with gemcitabine — DRUG
    comparison of different (ascending) doses of TRX518 in combination with gemcitabine
  • TRX518 with pembrolizumab — DRUG
    comparison of different (ascending) doses of TRX518 in combination with pembrolizumab
  • TRX518 with nivolumab — DRUG
    comparison of different (ascending) doses of TRX518 in combination with nivolumab

Study Details

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).

Key Dates

Start date
Jan 31, 2016
Status verified
Jul 2025
Primary completion
Jul 14, 2020
Completion
Jul 14, 2020

Study Design

Enrollment
109 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: TRX518 monotherapy (Parts A and B)
    Subjects receive an assigned dose of TRX518 administered intravenously one time per week or one time per cycle on a 21-day cycle
  • Experimental: TRX518 with gemcitabine (Part C)
    Subjects receive an assigned dose of TRX518 (dosed one time per cycle) intravenously administered in combination with gemcitabine (dosed two times per cycle) on a 21-day cycle
  • Experimental: TRX518 with pembrolizumab (Part D
    Subjects receive an assigned dose of TRX518 (dosed one time per cycle) intravenously administered in combination with pembrolizumab (dosed one time per cycle) on a 21-day cycle
  • Experimental: TRX518 with nivolumab (Part E)
    Subjects receive an assigned dose of TRX518 (dosed two times per cycle) intravenously administered in combination with nivolumab (dosed two times per cycle) on a 28-day cycle

Primary Outcome Measure

Adverse events [ Time Frame: through 30 days post last dose ]

Locations (6)

FacilityCityStateZIPSite coordinators
University of ChicagoChicagoIllinois60637-
University of New Mexico Comprehensive Cancer CenterAlbuquerqueNew Mexico87131-
Cleveland ClinicClevelandOhio44195-
University HospitalsClevelandOhio44106-
University of Pittsburgh Medical CenterPittsburghPennsylvania15232-
Tennessee OncologyNashvilleTennessee37205-

Find similar trials in Chicago, IL

By research site
University of Chicago· Chicago, ILUniversity of New Mexico Comprehensive Cancer Center· Albuquerque, NMCleveland Clinic· Cleveland, OHUniversity Hospitals· Cleveland, OHUniversity of Pittsburgh Medical Center· Pittsburgh, PATennessee Oncology· Nashville, TN

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