Phase IIIa Study of the Oral ATR Kinase Inhibitor ART0380 Alone or with Gemcitabine or Irinotecan for Advanced or Metastatic Solid Tumors

What this Trial Is About

Researchers are evaluating ART0380, a new oral drug that targets ATR kinase, in adults with advanced or metastatic solid tumors, including ovarian, peritoneal, fallopian tube, endometrial, colorectal, pancreatic, and acinar cell cancers. This open-label Phase IIIa study aims to find the recommended safe dose of ART0380 alone and combined with gemcitabine or irinotecan, understand side effects, and assess early signs of effectiveness. Participants will receive ART0380 either alone or in combination with gemcitabine or irinotecan in 21-day treatment cycles. ART0380 dosing schedules include intermittent or continuous oral administration. Gemcitabine is given on Days 1 and 8, and irinotecan is given as a 90-minute infusion on Days 1 and 8. The study has multiple parts evaluating different dosing regimens and patient groups, including dose escalation and dose expansion cohorts, with some participants randomized to receive combination therapy or gemcitabine alone. During the study, participants will undergo regular assessments including imaging scans to measure tumor response, blood tests for safety and pharmacokinetics, and tumor marker evaluations over several months. Researchers will monitor side effects from the treatments and measure outcomes such as maximum tolerated dose, progression-free survival, response rates, and overall survival. The study includes follow-up for up to 24 months to observe long-term effects.

A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors