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NCT06234098 · ClinicalTrials.gov registry record · Phase 1
Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmocodynamics and Preliminary Antitumor Activity of AT-1965 in Patients With Advanced, Refractory or Recurrent Solid Tumors
A Phase 1 study of Solid Tumor, sponsored by Alyssum Therapeutics.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 85
- Enrollment target
- 7
- Study locations
NCT06234098: Recruiting Phase 1 study of Solid Tumor, sponsored by Alyssum Therapeutics.
NCT06234098 is a Phase 1 study of Solid Tumor that is actively recruiting participants, run by Alyssum Therapeutics. The registered enrollment target is 85 participants, below the 221-participant average among 196 other Solid Tumor trials with a reported enrollment target (62% lower). The trial reports 7 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06234098, a Phase 1 study of Solid Tumor, is actively recruiting participants, sponsored by Alyssum Therapeutics.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 85 participants
- Enrollment target
- 7
- Study locations
Study Summary
This is a first-in-human, multicenter, open-label, dose escalation and dose expansion Phase 1/2 study to determine the MTD and/or the recommended Phase 2 dose (RP2D) and to characterize DLTs of AT-1965 as well as to investigate the safety, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of AT-1965 in patients with advanced, refractory or recurrent solid tumors (nonresectable and/or metastatic) including mTNBC.
Primary Outcome
Nature and frequency of dose-limiting toxicities (DLTs) associated with AT-1965 administration, maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D)
Conditions Studied
Interventions
- DRUG AT-1965 Liposome Injection
Study Locations (7)
California
- CBCC Global Research Site 005 - Bakersfield
- CBCC Global Research Site 007 - El Segundo
- CBCC Global Research Site 008 - Santa Monica
- CBCC Global Research Site 003 - Stanford
Arizona
- CBCC Global Research Site 001 - Scottsdale
Oregon
- CBCC Global Research Site 002 - Portland
Texas
- CBCC Global Research Site 006 - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 85 participants |
| Start Date | 2024-02-13 |
| Est. Completion | 2027-01 |
| Phase | Phase 1 |
What NCT06234098 shows while recruiting
NCT06234098 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 85 participants, a relatively small participant target, below the 221-participant average among 196 other Solid Tumor trials with a reported enrollment target (62% lower).
The record links to 1 condition, with Solid Tumor appearing as the primary indexed condition, and to 1 intervention - of which AT-1965 Liposome Injection is the first listed.
NCT06234098 lists 7 locations in 4 states (California, Arizona, Oregon).
Frequently Asked Questions
What is clinical trial NCT06234098 about?
NCT06234098 is a clinical study titled "Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmocodynamics and Preliminary Antitumor Activity of AT-1965 in Patients With Advanced, Refractory or Recurrent Solid Tumors". This is a first-in-human, multicenter, open-label, dose escalation and dose expansion Phase 1/2 study to determine the MTD and/or the recommended Phase 2 dose (RP2D) and to characterize DLTs of AT-1965 as well as to investigate the safety, pharmacokinetics (PK), pharmacodynamics, and preliminary ant...
What is the current status of trial NCT06234098?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 85 participants. The study started on 2024-02-13. Estimated completion is 2027-01.
What conditions does trial NCT06234098 study?
This clinical trial studies the following conditions: Solid Tumor.
What interventions are being tested in trial NCT06234098?
The interventions under investigation include: AT-1965 Liposome Injection (DRUG).
Who is sponsoring clinical trial NCT06234098?
This trial is sponsored by Alyssum Therapeutics, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06234098 being conducted?
This trial has 7 study locations across Arizona, California, Oregon, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Solid Tumor
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 NCT06234098's enrollment target sits among peer trials
85 95th of 196 higher than 101 of 196 other Solid Tumor trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Solid Tumor 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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