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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: Completed Phase 1 study, sponsored by Leap Therapeutics.
NCT02628574 is a Phase 1 study that has completed, run by Leap Therapeutics. The registered enrollment target is 109 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% higher). According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
Any adverse change in health or side effect from the initiation of the study drug dose TRX518 monotherapy and TRX518 in combination with gemcitabine, pembrolizumab or nivolumab through completion or premature withdrawal
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 |
What the finished NCT02628574 record still lists
NCT02628574 is an interventional study that assigns participants to a tested intervention. The registered 109 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% higher).
The record links to 0 conditions, and to 4 interventions - of which TRX518 monotherapy is the first listed.
NCT02628574 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02628574's enrollment target sits among peer trials
109 522nd of 2000 higher than 1,478 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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