Folic Acid-Tubulysin Conjugate EC1456 In Patients With Advanced Solid Tumors
Status:
Completed
Trial end date:
2018-04-26
Target enrollment:
Participant gender:
Summary
Phase 1A/B, multicenter, open-label, non-randomized, dose-escalation oncology study to
evaluate the administration of EC1456 in advanced solid tumors. In part A, EC1456 will be
dose escalated on 4 concurrently enrolling schedules. FR-positive expression on a
99mTc-etarfolatide scan is not required for inclusion in Part A.
Part B of the study will confirm the maximum tolerated dose (MTD) and the recommended Phase 2
(RP2) dose of EC1456, and evaluate the efficacy of EC1456 in NSCLC all subtype patient
populations with FR-positive cancer in up to three schedules (i.e., twice weekly, once
weekly, and four times weekly). FR-positive expression on a 99mTc-etarfolatide scan is
required for inclusion in Part B.
Minimum length of patient participation is anticipated to be 10 weeks (two 3-week cycles
followed by a 30 day follow-up period).