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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 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.

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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.

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

FieldValue
Enrollment Target 85 participants
Start Date 2024-02-13
Est. Completion 2027-01
Phase Phase 1

Sponsor

Alyssum Therapeutics

1 total trials

What the Registry Record Tells You About NCT06234098

The ClinicalTrials.gov registry entry for NCT06234098 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 85 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 221-participant average among 196 other Solid Tumor trials with a reported enrollment target (62% lower). The listed sponsor is Alyssum Therapeutics, which has 1 total studies on file at ClinicalTrials.gov.

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 reports 7 study locations spanning 4 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

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