Phase 1ab Study of ADCX-020 Anticancer Therapy in Adults With Advanced or Metastatic Solid Tumors

What this Trial Is About

Researchers are studying ADCX-020, an investigational antibody drug conjugate, in patients with advanced or metastatic solid tumors that have relapsed or are refractory to standard treatments. This first-in-human Phase 1ab trial aims to evaluate the safety, tolerability, pharmacokinetics, and early effectiveness of ADCX-020 in these patients. The study is sponsored by Adcytherix SAS and includes patients who have measurable disease and meet specific health criteria. The study has two main parts Phase 1a involves dose escalation where participants receive increasing doses of ADCX-020 intravenously to find the maximum tolerated dose. Phase 1b focuses on dose optimization and expansion, assessing two or more dose levels or dosing regimens in different patient groups to determine the recommended Phase 2 dose. Both phases are overseen by expert committees to ensure safety and appropriate dose selection. Participants will be monitored from the start of treatment through follow-up periods that can extend up to about 24 months. Researchers will assess safety and tolerability, measure drug levels in the blood, and evaluate tumor responses using imaging criteria. They will also track progression, survival, and immune reactions to the drug. Study visits include clinical evaluations, tumor assessments, and laboratory tests to carefully monitor participants health and treatment effects.

ADCX-020 for the Treatment of Patients With Locally Advanced or Metastatic Cancers