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NCT02628574 · ClinicalTrials.gov registry record · Phase 1
Phase 1 Open-label Study of TRX518 Monotherapy and TRX518 in Combination With Gemcitabine, Pembrolizumab, or Nivolumab
A Phase 1 study, sponsored by Leap Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 109
- Enrollment target
NCT02628574 is a Phase 1 study that has completed, run by Leap Therapeutics. The registered enrollment target is 109 participants.
The verdict
NCT02628574, a Phase 1 study, has completed, sponsored by Leap Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 109 participants
- Enrollment target
Study 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).
Interventions
- DRUG TRX518 monotherapy
- DRUG TRX518 with gemcitabine
- DRUG TRX518 with pembrolizumab
- DRUG TRX518 with nivolumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 109 participants |
| Start Date | 2016-01 |
| Est. Completion | 2020-07-14 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02628574
The ClinicalTrials.gov registry entry for NCT02628574 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 109 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Leap Therapeutics, which has 10 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which TRX518 monotherapy is the first listed.
NCT02628574 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02628574 about?
NCT02628574 is a clinical study titled "Phase 1 Open-label Study of TRX518 Monotherapy and TRX518 in Combination With Gemcitabine, Pembrolizumab, or Nivolumab". 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-limitin...
What is the current status of trial NCT02628574?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 109 participants. The study started on 2016-01. Estimated completion is 2020-07-14.
What interventions are being tested in trial NCT02628574?
The interventions under investigation include: TRX518 monotherapy (DRUG), TRX518 with gemcitabine (DRUG), TRX518 with pembrolizumab (DRUG), TRX518 with nivolumab (DRUG).
Who is sponsoring clinical trial NCT02628574?
This trial is sponsored by Leap Therapeutics, which has 10 total clinical trials registered on ClinicalTrials.gov.
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