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NCT03489343 · ClinicalTrials.gov registry record · Phase 1
Sym023 (Anti-TIM-3) in Patients With Advanced Solid Tumor Malignancies or Lymphomas
A Phase 1 study of Lymphoma and Solid Tumor, sponsored by Symphogen A/S.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 4
- Study locations
NCT03489343: Completed Phase 1 study of Lymphoma and Solid Tumor, sponsored by Symphogen A/S.
NCT03489343 is a Phase 1 study of Lymphoma and Solid Tumor that has completed, run by Symphogen A/S. The registered enrollment target is 24 participants, below the 484-participant average among 299 other Lymphoma trials with a reported enrollment target (95% lower). The trial reports 4 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03489343, a Phase 1 study of Lymphoma and Solid Tumor, has completed, sponsored by Symphogen A/S.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 4
- Study locations
Study Summary
This was the first study to test Sym023 in humans. The primary purpose of this study was to see if Sym023 is safe and tolerable for patients with locally advanced/unresectable or metastatic solid tumor malignancies or lymphomas that are refractory to available therapy or for which no standard therapy is available.
Primary Outcome
Assess the safety and tolerability of Sym023 on a Q2W (once every 2 weeks) schedule to establish the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D). Assessment based on the occurrence of AEs meeting DLT criteria measured during Cycle 1. The MTD was to be determined by those DLTs that occurred during C1 in either more than 1 patient in a 3 to 6 patient cohort or ≥33.3% of patients in the event of an expanded 7 to 12 patient cohort. One patient in the 10.0 mg/kg dose cohort wa
Conditions Studied
Interventions
- DRUG Sym023
Study Locations (4)
Texas
- The University of Texas MD Anderson Cancer Center - Houston
- NEXT Oncology - San Antonio
Michigan
- South Texas Accelerated Research Therapeutics (START) Midwest - Grand Rapids
Ontario
- Princess Margaret Cancer Centre - Toronto
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2018-05-24 |
| Est. Completion | 2020-06-03 |
| Phase | Phase 1 |
What the finished NCT03489343 record still lists
NCT03489343 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 484-participant average among 299 other Lymphoma trials with a reported enrollment target (95% lower).
The record links to 3 conditions, with Lymphoma appearing as the primary indexed condition, and to 1 intervention - of which Sym023 is the first listed.
NCT03489343 reports a single indexed study location in Texas, Michigan, Ontario.
Frequently Asked Questions
What is clinical trial NCT03489343 about?
NCT03489343 is a clinical study titled "Sym023 (Anti-TIM-3) in Patients With Advanced Solid Tumor Malignancies or Lymphomas". This was the first study to test Sym023 in humans. The primary purpose of this study was to see if Sym023 is safe and tolerable for patients with locally advanced/unresectable or metastatic solid tumor malignancies or lymphomas that are refractory to available therapy or for which no standard therap...
What is the current status of trial NCT03489343?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2018-05-24. Estimated completion is 2020-06-03.
What conditions does trial NCT03489343 study?
This clinical trial studies the following conditions: Lymphoma, Solid Tumor, Metastatic Cancer.
What interventions are being tested in trial NCT03489343?
The interventions under investigation include: Sym023 (DRUG).
Who is sponsoring clinical trial NCT03489343?
This trial is sponsored by Symphogen A/S, which has 12 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03489343 being conducted?
This trial has 4 study locations across Michigan, Texas, Ontario. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Lymphoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03489343's enrollment target sits among peer trials
24 235th of 299 higher than 61 of 299 other Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Lymphoma 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.
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