Phase 1 Study of ANS014004 Drug for Safety, Tolerability, and Early Effect in Adults With Locally Advanced or Metastatic Solid Tumors

What this Trial Is About

Researchers are evaluating ANS014004 in adults with locally advanced or metastatic solid tumors in this Phase 1, first-in-human, open-label, multi-center study. The study aims to explore the safety, tolerability, how the drug moves through the body, and preliminary anti-tumor activity of ANS014004 when used alone. This early-phase research is important to understand how the drug behaves and its potential effects on tumors in patients with these advanced cancers. The study has two parts. Part 1 focuses on determining the safety, tolerability, and the best dose for future studies by gradually increasing the dose of ANS014004. Part 2 will further evaluate safety and assess anti-tumor activity of ANS014004 as a single treatment in selected solid tumors. Participants will receive varying doses of ANS014004 during these parts, with careful monitoring throughout. Participants will be closely observed from the first dose through 28 days after the last dose for side effects, laboratory tests, heart function, and vital signs. Researchers will also monitor tumor response using imaging over about two years or until disease progression. Additional assessments include measuring how the drug is processed in the body. The study ensures participant safety with regular evaluations and aims to gather detailed information on the drugs effects and tolerability over time.

A Study to Investigate ANS014004 in Participants With Locally Advanced or Metastatic Solid Tumors