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NCT05943990 · ClinicalTrials.gov registry record · Phase 1
Study of GSK3845097 in Previously Treated Participants With Advanced Synovial Sarcoma and Myxoid/Round Cell Liposarcoma
A Phase 1 study, sponsored by Adaptimmune.
- Terminated
- Registry status
- Phase 1
- Development phase
- 5
- Enrollment target
NCT05943990: Clinical Trial Phase 1 study, sponsored by Adaptimmune.
NCT05943990 is a Phase 1 study that was terminated before completion, run by Adaptimmune. The registered enrollment target is 5 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05943990, a Phase 1 study, was terminated before completion, sponsored by Adaptimmune.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 5 participants
- Enrollment target
Study Summary
To assess the safety, tolerability and determine recommended phase 2 dose (RP2D) of GSK3845097 in HLA-A\*02:01, HLA-A\*02:05 and/or HLA-A\*02:06 positive participants with New York esophageal squamous cell carcinoma (NY-ESO)-1 and/or Cancer testis antigen 2 (LAGE-1a) positive, previously treated, advanced (metastatic or unresectable) Synovial Sarcoma (SS) and Myxoid/Round Cell Liposarcoma (MRCLS).
Primary Outcome
DLT events were graded according to NCI-CTCAE v5.0. DLTs were defined as Grade (Gr) 4 (life-threatening and death) related to GSK3845097 2) Gr 3 (Severe or medically significant) at least possibly related to GSK3845097 and do not resolve to Gr \<=1 (or Baseline) within 7 days from the onset of the event 3) Gr \>=3 non-infectious pneumonitis not responding to oxygen supplementation and systemic steroid treatment 4) Any Gr 3 cytokine release syndrome (CRS) at least possibly related to GSK3845097 t
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- DRUG GSK3845097
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2020-12-21 |
| Est. Completion | 2022-10-24 |
| Phase | Phase 1 |
Why NCT05943990 stopped before completion
NCT05943990 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 3 interventions - of which Cyclophosphamide is the first listed.
NCT05943990 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05943990 about?
NCT05943990 is a clinical study titled "Study of GSK3845097 in Previously Treated Participants With Advanced Synovial Sarcoma and Myxoid/Round Cell Liposarcoma". To assess the safety, tolerability and determine recommended phase 2 dose (RP2D) of GSK3845097 in HLA-A\*02:01, HLA-A\*02:05 and/or HLA-A\*02:06 positive participants with New York esophageal squamous cell carcinoma (NY-ESO)-1 and/or Cancer testis antigen 2 (LAGE-1a) positive, previously treated, ad...
What is the current status of trial NCT05943990?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 5 participants. The study started on 2020-12-21. Estimated completion is 2022-10-24.
What interventions are being tested in trial NCT05943990?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), GSK3845097 (DRUG).
Who is sponsoring clinical trial NCT05943990?
This trial is sponsored by Adaptimmune, which has 13 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05943990's enrollment target sits among peer trials
5 1989th of 2000 higher than 6 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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