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Brief Title: A Study Evaluating AB248 Alone or in Combination With Pembrolizumab in Adult Patients With Solid Tumors
Official Title: An Open-Label Phase 1a/1b Dose-Escalation and Expansion Study Investigating the Safety, Pharmacokinetics, Pharmacodynamics, and Activity of AB248 Alone or in Combination With Pembrolizumab in Adult Patients With Locally Advanced or Metastatic Solid Tumors
Study ID: NCT05653882
Brief Summary: This is a phase I, First-in-Human (FIH), open-label study to evaluate the safety, tolerability, pharmacokinetic (PK) profile, and preliminary efficacy of AB248 as monotherapy OR in combination with pembrolizumab in adult participants with locally advanced or metastatic solid tumors. The study will consist of a dose escalation and a dose expansion stage.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Investigational Site 002, Los Angeles, California, United States
Investigational Site 009, San Francisco, California, United States
Invesigational Site 004, New Haven, Connecticut, United States
Investigational Site 011, Miami, Florida, United States
Investigational Site 010, Ocala, Florida, United States
Investigational Site 005, Lafayette, Indiana, United States
Investigational Site 001, Boston, Massachusetts, United States
Investigational Site 014, Detroit, Michigan, United States
Investigational Site 012, Saint Louis, Missouri, United States
Investigational Site 008, Nashville, Tennessee, United States
Name: Medical Monitor
Affiliation: Asher Biotherapeutics, Inc.
Role: STUDY_DIRECTOR