Phase 1/2a Study of ICT01 Plus Low Dose SC IL-2 in Patients With Advanced Solid Tumors
Status:
Not yet recruiting
Trial end date:
2023-12-01
Target enrollment:
Participant gender:
Summary
This is a phase I/IIa, two-part, open-label study to characterize the safety, tolerability,
pharmacodynamics, and antitumor activity of ICT01 in combination with LDSC IL-2 in patients
with advanced-stage solid tumors.
Part 1 will be a dose escalation of IV ICT01 administered on the first day of every 21-day
cycle (CnD1) to patients with advanced-stage solid tumors in combination with LDSC IL-2
(Proleukin®) administered daily on days 1-5 of cycles 1-3 (C1-3D1-5). Objectives of part 1
are to characterize the safety of the combination regimen and determine the RP2D for Part 2.
Part 2 will comprise a maximum of 2 indications and 2 combination dosing regimens, which will
be supported by statistical power calculations once the indications are selected. The start
of Part 2 will require an amendment to confirm the indication(s) and dosing regimen(s), which
will be based on the review of Part 1 data and recommendations by the SRC. The primary
objective of Part 2 is to demonstrate the efficacy of the combination regimen based on
RECIST1.1.