Solid Tumors Clinical Trial
Official title:
A Phase I A/B Study of the Folic Acid-Tubulysin Conjugate EC1456 In Patients With Advanced Solid Tumors
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).
In part A, EC1456 will be dose escalated on 4 concurrently enrolling schedules.
Treatment 1 is EC1456 BIW on Days 1, 4, 8, and 11 of a 3-week schedule (BIW); Treatment 2 is
EC1456 QW on Days 1 and 8 of a 3-week schedule (QW); Treatment 3 is EC1456 QW on Days 1, 8,
and 15 of a 3-week schedule (CWD) and Treatment 4 is EC1456 QIW on Days 1, 2, 3, 4, 8, 9, 10,
and 11 of a 3-week schedule (QIW).
In part B, EC1456 will be dosed on 3 concurrently enrolling schedules:
Treatment 5 is EC1456 BIW. Once a dose is determined in Part A, Part B will begin with 3-6
subjects who will receive consecutive day dosing on Days 1, 2, 8, and 9 of a 3-week schedule.
If this is not tolerated, the BIW cohort will continue with dosing on Days 1, 4, 8, and 11 of
a 3-week schedule; Treatment 6 is EC1456 QW on Days 1 and 8 of a 3-week schedule or CWD on
Days 1, 8 and 15 of a 3-week schedule; Treatment 7 is EC1456 QIW on Days 1, 2, 3, 4, 8, 9,
10, and 11 of a 3-week schedule for at least two cycles. If the patient is eligible to
continue treatment (based upon treatment response and tolerability), he/she may opt to
continue on the QIW schedule or change to the Treatment 6 regimen schedule (once its MTD and
schedule have been determined).
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