A Phase 1 Study Evaluating CB-5083 in Subjects With Advanced Solid Tumors

Summary

This is a multicenter, open-label, Phase 1 study of orally administered CB-5083 in adult subjects with advanced metastatic solid tumors. The study will be conducted in 2 parts: an initial Dose Escalation Phase (Phase 1a) of CB-5083 in subjects with advanced metastatic solid tumors who have progressed or are non-responsive to available therapies and for which no standard therapy exists, followed by a Dose Expansion Phase (Phase 1b) which will include 1 to 4 arms: one arm in subjects with RAS mutated mCRC; optionally, at sponsors discretion, 3 additional arms may be added for subjects with advanced RCC, advanced pNET, or solid tumors with mutations in the RAS-MAPK pathway.

Timeline

Start

2014-10-11

Primary completion

2017-08-25

Completion

2017-08-25

Outcome

Outcome not reported

Stopped: “MTD determined”

Drugs

Indications