A Phase 1/2 Study of BBI-825 in People With Advanced Solid Tumors

Full Title

An Open-Label, Multicenter, First-in-Human, Dose-Escalation and Dose-Expansion, Phase 1/2 Study of BBI-825 and BBI-825 in Combination with Select Targeted Therapies in Subjects with Locally Advanced or Metastatic Solid Tumors with Resistance Gene Amplifications

Purpose

Researchers want to find the best dose of BBI-825 to treat cancer. The people in this study have solid tumors that keep growing after treatment and cannot be taken out with surgery.

BBI-825 blocks a protein called RNR. Cancer cells, particularly those with multiple copies of a gene (called amplification), need RNR to grow. So blocking RNR might stop or slow the growth of cancer. BBI-825 is taken orally (by mouth).

Who Can Join

To join this study, there are a few conditions. You must:

• Have a solid tumor that came back or keeps growing even after treatment and cannot be taken out with surgery.
• Have cancer with a gene amplification or colorectal cancer with a BRAF V600E or KRAS G12C mutation and will receive targeted therapy.
• Have recovered from the serious side effects of prior anti-cancer treatments before taking BBI-825.
• Be well enough to walk and take care of yourself. You must be able to do activities such as office work or light housework.
• Be 18 or older.

Contact

For more information and to see if you can join this study, please call Dr. Rona Yaeger’s office at 646-888-5109.