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NCT03861403 · ClinicalTrials.gov registry record · Phase 1
A Dose Escalation and Expansion Study of TRX518 in Combination With Cyclophosphamide Plus Avelumab in Advanced Solid Tumors
A Phase 1 study, sponsored by Leap Therapeutics.
- Terminated
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
NCT03861403 is a Phase 1 study that was terminated before completion, run by Leap Therapeutics. The registered enrollment target is 10 participants.
The verdict
NCT03861403, a Phase 1 study, was terminated before completion, sponsored by Leap Therapeutics.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
Study Summary
This is a Phase 1b/2a dose escalation and expansion, multi-center study to be conducted in 2 phases: * Phase 1b * Dose Escalation Part 1 (Doublet Therapy) * Dose Escalation Part 2 (Triplet Therapy) * Phase 2a * Dose Expansion (Triplet Therapy) Approximately 125 adult patients with histologically confirmed advanced solid tumors requiring therapy will be enrolled in the study. It is expected that approximately 24 patients will be enrolled in up to 4 cohorts, 2 cohorts in Dose Escalation Part 1 and 2 cohorts in Dose Escalation Part 2, of up to 6 patients per cohort. Up to 98 additional patients will be enrolled in the Dose Expansion phase of the study to achieve 88 evaluable patients (i.e., received at least 1 dose of study drug(s) and have 1 evaluable post-baseline modified RECIST v1.1 tumor response assessment; for mCRPC, assessment of soft tissue response will be per modified RECIST v1.1 and bone progression assessment will be per PCWG3 guidelines or discontinued treatment due to death, toxicity, or clinical progression) over 4 independent expansion groups.In either phase (1b or 2a), patients discontinuing for reasons unrelated to study treatment toxicity prior to completion of Cycle (C) 1 may be replaced to achieve the number of required evaluable patients per cancer type following consultation with the Sponsor. Data from each cohort in the Dose Escalation phase will be evaluated independently for safety and dose limiting toxicities (DLTs) prior to dose escalation and again prior to the Dose Expansion phase.
Interventions
- DRUG Cyclophosphamide
- DRUG Avelumab
- DRUG TRX518
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2019-05-20 |
| Est. Completion | 2020-07-14 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03861403
The ClinicalTrials.gov registry entry for NCT03861403 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 10 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 3 interventions - of which Cyclophosphamide is the first listed.
NCT03861403 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03861403 about?
NCT03861403 is a clinical study titled "A Dose Escalation and Expansion Study of TRX518 in Combination With Cyclophosphamide Plus Avelumab in Advanced Solid Tumors". This is a Phase 1b/2a dose escalation and expansion, multi-center study to be conducted in 2 phases: * Phase 1b * Dose Escalation Part 1 (Doublet Therapy) * Dose Escalation Part 2 (Triplet Therapy) * Phase 2a * Dose Expansion (Triplet Therapy) Approximately 125 adult patients with histolog...
What is the current status of trial NCT03861403?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2019-05-20. Estimated completion is 2020-07-14.
What interventions are being tested in trial NCT03861403?
The interventions under investigation include: Cyclophosphamide (DRUG), Avelumab (DRUG), TRX518 (DRUG).
Who is sponsoring clinical trial NCT03861403?
This trial is sponsored by Leap Therapeutics, which has 10 total clinical trials registered on ClinicalTrials.gov.
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