A Study of DCC-2701 in Participants With Advanced Solid Tumors

A Multicenter Phase 1 Ascending Dose Study of DCC-2701 To Assess Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics in Patients With Advanced Solid Tumors

The main purpose of this study is to investigate the safety of the investigational drug DCC-2701 and whether it will work to help people who have advanced solid tumors or cancer that has spread to other parts of the body.

This is a first-in-human study of DCC-2701. The primary purpose of this study is to determine what dose of DCC-2701, can be given safely to patients with advanced solid tumors.

The study will have two phases. The first phase will assess escalating doses of DCC-2701 in order to determine the maximally tolerated dose (MTD) and the optimal dosing regimen (ODR) of DCC-2701. Once the MTD and ODR is established, a dose expansion phase will further evaluate the safety of DCC-2701, as well as the activity of DCC-2701 in select solid tumor types.

Inclusion Criteria:

• Advanced or metastatic solid tumor that has progressed or was not responsive to standard therapy
• The cancer has no proven effective therapy
• The cancer can be biopsied (depending on the tumor type and/or the dose of drug received, tumor biopsies may be required)
• Able to swallow tablets

Exclusion Criteria:

• Have active central nervous system (CNS) metastasis
• Have an active infection of any kind (fungal, viral, or bacterial)
• Are pregnant or breastfeeding