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Dose Escalation Study of TRX518 in Adults With Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT02628574
Recruitment Status : Recruiting
First Posted : December 11, 2015
Last Update Posted : February 14, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This study will be conducted in 2 parts (Part A and Part B). Subjects ≥18 years with advanced solid tumors will be enrolled in the study. 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).

Condition or disease Intervention/treatment Phase
Solid Tumors Drug: TRX518 Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Two Part, Phase 1, Multicenter, Open-label Study of TRX518 in Adults With Advanced Solid Tumors Part A: A Dose-Escalation Study of Multi-dose TRX518 Monotherapy Part B: An Expansion Cohort of Multi-dose TRX518 Monotherapy at the Maximum Tolerated Dose
Study Start Date : December 2015
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : August 2018
Arms and Interventions

Arm Intervention/treatment
Experimental: TRX518
Subjects receive an assigned dose of TRX518 administered intravenously one time per week on a 21-day cycle
Drug: TRX518
comparison of different (ascending) doses of TRX518 given via IV fusion


Outcome Measures

Primary Outcome Measures :
  1. Adverse events [ Time Frame: through 30 days post last dose ]
    Any adverse change in health or side effect from the initiation of the study drug dose through completion or premature withdrawal


Secondary Outcome Measures :
  1. TRX518 peak concentration (Cmax) [ Time Frame: various timepoints through 1 week post dose ]
    Observations of the distribution, duration of effects and chemical changes of TRX518 in the body and the effects and routes of the body's elimination of TRX518

  2. Time to peak concentration (Tmax) [ Time Frame: various timepoints through 1 week post dose ]
    Observations of the distribution, duration of effects and chemical changes of TRX518 in the body and the effects and routes of the body's elimination of TRX518

  3. Area under the curve (AUC) [ Time Frame: various timepoints through 1 week post dose ]
    Observations of the distribution, duration of effects and chemical changes of TRX518 in the body and the effects and routes of the body's elimination of TRX518

  4. RECIST assessment for evidence of antitumor activity [ Time Frame: up to 1 year ]
    RECIST assessment to determine effects of TRX518 on solid tumors.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Advanced Solid Malignancies with at least 1 measurable lesion, who have failed to respond to or relapsed following standard treatment or who have declined to pursue standard treatment, in otherwise stable health (as confirmed by medical history, physical examination, ECG, and screening laboratory tests).
  • Expected survival of at least 12 weeks after dosing.
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
  • Evidence of adequate organ function by standard laboratory tests.
  • All female subjects of child bearing age must be either surgically sterile, postmenopausal for at least 1 year, or using an acceptable method of contraception. Adequate contraception for both male and female subjects must be used from the beginning of the screening period until at least 8 weeks after the last dose of TRX518.

Exclusion Criteria:

  • Hematologic malignancies or multiple myeloma.
  • Known, clinically important cardiac or respiratory disease
  • Any concomitant serious physical illness other than cancer (e.g., immune deficiency disease, bleeding disorder, etc.) within 1 year prior to dosing. No history of autoimmune disease.
  • Active, uncontrolled infections within 7 days of study entry requiring systemic therapy.
  • Evidence of progression of central nervous system (CNS) metastases or symptomatic CNS metastases within 30 days prior to dosing.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02628574


Contacts
Contact: Cyndi Sirard, MD (617) 714-0357 CSirard@leaptx.com
Contact: Reena Lynam (617) 665-5206 RLynam@leaptx.com

Locations
United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Jason Luke, MD       jluke@medicine.bsd.uchicago.edu   
United States, New Mexico
University of New Mexico Comprehensive Cancer Center Recruiting
Albuquerque, New Mexico, United States, 87131
Contact: Olivier Rixe, MD       ORixe@salud.unm.edu   
United States, Ohio
University Hospitals Recruiting
Cleveland, Ohio, United States, 44106
Contact: Henry Koon, MD       Henry.Koon@UHhospitals.org   
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Vamsidhar Velcheti, MD       velchev@ccf.org   
United States, Pennsylvania
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Diwakar Davar, MD       davard@upmc.edu   
United States, Tennessee
Tennessee Oncology Recruiting
Nashville, Tennessee, United States, 37205
Contact: Todd Bauer, MD       tbauer@tnonc.com   
Contact: Erin Fisher       Erin.Fisher2@scresearch.net   
Sponsors and Collaborators
Leap Therapeutics, Inc.
Investigators
Study Chair: Cyndi Sirard, MD Leap Therapeutics, Inc.
More Information

Responsible Party: Leap Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02628574     History of Changes
Other Study ID Numbers: TRX518-003
First Posted: December 11, 2015    Key Record Dates
Last Update Posted: February 14, 2017
Last Verified: February 2017

Keywords provided by Leap Therapeutics, Inc.:
Metastatic
Stage III or IV
recurrent
refractory
solid tumors