Phase 12 Study of CP-383 Oral Treatment in Adults with Advanced or Metastatic Solid Tumors

What this Trial Is About

Researchers are studying an investigational drug called CP-383 to see if it can slow or stop the growth of advanced cancers and to learn about its safety. This trial includes many types of solid tumors, including colorectal cancer, lung cancers, head and neck cancer, bladder cancer, and pancreatic cancer. The study will also explore if cancers with certain gene mutations respond better to CP-383. The study is a Phase 12 open-label trial led by Tasca Therapeutics. Participants will take CP-383 by mouth once daily at different dose levels ranging from 0.8 mg to 12 mg. The trial has two parts the first part determines the maximum tolerated dose over 21 days, while the second part evaluates the drugs effects in selected tumor types at the recommended dose for about one year. Expansion groups will further study CP-383 in chosen tumor types at the recommended dose. During the study, participants will visit the clinic weekly for the first six weeks for checkups and tests, then every three weeks afterward. Researchers will monitor changes in cancer growth, safety, drug levels in the body, and other health measures. The total study duration varies but includes regular assessments throughout treatment and follow-up. Participants will be asked to provide tumor samples for lab testing and follow study protocols carefully.

Study of CP-383 in Patients With Advanced or Metastatic Solid Tumors