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Brief Title: Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmocodynamics and Preliminary Antitumor Activity of AT-1965 in Patients With Advanced, Refractory or Recurrent Solid Tumors
Official Title: 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
Study ID: NCT06234098
Brief 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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 003, Stanford, California, United States
CBCC Global Research Site 002, Portland, Oregon, United States
CBCC Global Research Site 006, Dallas, Texas, United States
Name: Richard Fahrner, PhD
Affiliation: Alyssum Therapeutics
Role: STUDY_DIRECTOR