Phase 1 Study of AGX101 Antibody-Drug Conjugate Given by IV to Adults With Advanced or Metastatic Solid Tumors

What this Trial Is About

Researchers are evaluating AGX101, an antibody-drug conjugate therapy, in people with advanced solid tumors including unresectable, locally advanced, or metastatic cancers. The study aims to learn about the safety, tolerability, and preliminary activity of AGX101 at different dose levels. This is a Phase 1, open-label, dose-escalation and expansion study involving participants with various solid tumors who have exhausted standard treatment options or for whom standard treatments are not suitable. AGX101 will be given by intravenous infusion starting with a 90-minute infusion, followed by a 60-minute infusion, and then subsequent 30-minute infusions on Day 1 of cycles repeated every 3, 6, or 9 weeks. The study includes a dose-escalation phase where doses are increased in groups of participants, followed by a dose-expansion phase focusing on a selected dose and cancer type. Participants may continue treatment until their disease progresses, unacceptable side effects occur, or they choose to stop. Participants will attend treatment visits according to the dosing schedule and have an end of treatment visit. Safety follow-up will be conducted via two telephone contacts up to 90 days after the last dose. Researchers will monitor adverse events, dosing tolerance, and treatment effects over approximately 6 months and up to 3 years. They will also assess pharmacokinetics, immune response to the drug, and measures of cancer response and survival during this period.

A Study to Evaluate Safety, Tolerability and Preliminary Activity of AGX101 in Participants With Advanced Solid Tumors