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NCT07541573 · ClinicalTrials.gov registry record · Phase 1
GTB-5550 in Advanced Solid Tumors
A Phase 1 study, sponsored by Masonic Cancer Center, University of Minnesota.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 175
- Enrollment target
NCT07541573: Recruiting Phase 1 study, sponsored by Masonic Cancer Center, University of Minnesota.
NCT07541573 is a Phase 1 study that is actively recruiting participants, run by Masonic Cancer Center, University of Minnesota. The registered enrollment target is 175 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (192% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07541573, a Phase 1 study, is actively recruiting participants, sponsored by Masonic Cancer Center, University of Minnesota.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 175 participants
- Enrollment target
Study Summary
This is a first-in-human Phase 1a/1b trial of a B7-H3-targeted natural killer (NK) cell engager, referred to as a TriSpecific Killer Engager (TriKE), for the treatment of select solid tumor cancers. To be considered for the study, a patient must be 18 years or older, have histologically or cytologically confirmed advanced/metastatic cancer that, based on literature reports, expresses B7-H3 at a high frequency, measurable disease by RECIST 1.1 (exception: mCRPC limited to bone metastasis are exempt from this requirement), meets the disease specific criteria for prior failed therapy, and refractory to, intolerant of, or ineligible for therapy options that are known to provide clinical benefit for their diagnosis.
Primary Outcome
The primary objective is to identify one of the six dose-level strategies of GTB-5550 (cam anti-CD16/WT IL 15/cam anti-B7-H3 TriKE) that corresponds to the desired maximum toxicity rate of less of equal to 20%, defining the MTD.
Interventions
- DRUG GTB-5550
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 175 participants |
| Start Date | 2026-04-08 |
| Est. Completion | 2032-01 |
| Phase | Phase 1 |
What NCT07541573 shows while recruiting
NCT07541573 is an interventional study that assigns participants to a tested intervention. The registered 175 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 (192% higher).
The record links to 0 conditions, and to 1 intervention - of which GTB-5550 is the first listed.
NCT07541573 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07541573 about?
NCT07541573 is a clinical study titled "GTB-5550 in Advanced Solid Tumors". This is a first-in-human Phase 1a/1b trial of a B7-H3-targeted natural killer (NK) cell engager, referred to as a TriSpecific Killer Engager (TriKE), for the treatment of select solid tumor cancers. To be considered for the study, a patient must be 18 years or older, have histologically or cytologic...
What is the current status of trial NCT07541573?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 175 participants. The study started on 2026-04-08. Estimated completion is 2032-01.
What interventions are being tested in trial NCT07541573?
The interventions under investigation include: GTB-5550 (DRUG).
Who is sponsoring clinical trial NCT07541573?
This trial is sponsored by Masonic Cancer Center, University of Minnesota, which has 249 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07541573's enrollment target sits among peer trials
175 319th of 2000 higher than 1,679 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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