RecruitingPhase 1Phase 2NCT06234098

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 1/2, Open-label Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmocodynamics and Preliminary Antitumor Activity of AT-1965 in Patients With Advanced, Refractory or Recurrent Solid Tumors


Sponsor

Alyssum Therapeutics

Enrollment

100 participants

Start Date

Feb 13, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called AT-1965 Liposome Injection for people with solid tumor. The study is currently recruiting participants at 7 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAT-1965 Liposome Injection

AT-1965 Liposome Injection administered intravenously once weekly for the first 3 weeks (Days 1, 8 and 15) of a 4 week cycle.


Locations(9)

CBCC Global Research Site 001

Scottsdale, Arizona, United States

CBCC Global Research Site 005

Bakersfield, California, United States

CBCC Global Research Site 007

El Segundo, California, United States

CBCC Global Research Site 008

Santa Monica, California, United States

CBCC Global Research Site 009

Santa Monica, California, United States

CBCC Global Research Site 003

Stanford, California, United States

CBCC Global Research Site 010

New York, New York, United States

CBCC Global Research Site 002

Portland, Oregon, United States

CBCC Global Research Site 006

Dallas, Texas, United States

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NCT06234098


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