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NCT04167137 · ClinicalTrials.gov registry record · Phase 1
Safety and Tolerability of SYNB1891 Injection Alone or in Combination With Atezolizumab in Adult Participants
A Phase 1 study, sponsored by Synlogic.
- Terminated
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
NCT04167137: Clinical Trial Phase 1 study, sponsored by Synlogic.
NCT04167137 is a Phase 1 study that was terminated before completion, run by Synlogic. The registered enrollment target is 32 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04167137, a Phase 1 study, was terminated before completion, sponsored by Synlogic.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
Study Summary
This Phase 1, open-label, multicenter, 2-arm study was designed to evaluate SYNB1891 when administered either as monotherapy (Arm 1) or in combination with atezolizumab (Arm 2) in participants with advanced/metastatic solid tumors or lymphoma. The primary objective was to evaluate the safety and tolerability of study treatment, with a secondary objective of assessing preliminary tumor response to treatment and exploratory objectives of evaluating the pharmacokinetics/pharmacodynamics (PK/PD) of study treatment.
Primary Outcome
The following adverse events (AEs) were DLTs if they occurred in Cycle 1 and were assessed by the Investigator as related to treatment: 1. Grade (Gr) 4 nonhematologic toxicity (not laboratory) 2. Gr 4 hematologic toxicity ≥ 7 days, any Gr 4 thrombocytopenia, or Gr 3 thrombocytopenia with significant bleeding 3. Gr ≥ 3 nonhematologic toxicity (exceptions: Gr 3 fatigue ≤ 3 days; Gr 3 diarrhea, nausea, or vomiting without treatment; Gr 3 rash without treatment) 4. Gr 3/4 nonhematologic laboratory
Interventions
- DRUG Atezolizumab
- DRUG SYNB1891
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2019-12-12 |
| Est. Completion | 2021-12-09 |
| Phase | Phase 1 |
Why NCT04167137 stopped before completion
NCT04167137 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower).
The record links to 0 conditions, and to 2 interventions - of which Atezolizumab is the first listed.
NCT04167137 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04167137 about?
NCT04167137 is a clinical study titled "Safety and Tolerability of SYNB1891 Injection Alone or in Combination With Atezolizumab in Adult Participants". This Phase 1, open-label, multicenter, 2-arm study was designed to evaluate SYNB1891 when administered either as monotherapy (Arm 1) or in combination with atezolizumab (Arm 2) in participants with advanced/metastatic solid tumors or lymphoma. The primary objective was to evaluate the safety and tol...
What is the current status of trial NCT04167137?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2019-12-12. Estimated completion is 2021-12-09.
What interventions are being tested in trial NCT04167137?
The interventions under investigation include: Atezolizumab (DRUG), SYNB1891 (DRUG).
Who is sponsoring clinical trial NCT04167137?
This trial is sponsored by Synlogic, which has 10 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04167137's enrollment target sits among peer trials
32 1296th of 2000 higher than 679 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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