A Phase 1/2 Study of ALKS 4230 in Subjects with Advanced tumour
Research type
Research Study
Full title
A Phase 1/2 Study of ALKS 4230 Administered Subcutaneously as Monotherapy and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors- ARTISTRY-2 (001)
IRAS ID
273756
Contact name
Mark Middleton
Contact email
Sponsor organisation
Alkermes, Inc.
Eudract number
2019-002013-20
Clinicaltrials.gov Identifier
Duration of Study in the UK
5 years, 0 months, 1 days
Research summary
The purpose of this study is to explore the safety and tolerability of ALKS 4230 (study drug)as monotherapy(used without any other drug) and in combination with pembrolizumab for the treatment of participants with advanced tumour.
Up to 257 participants are expected to take part in this study; approximately 33 to 75 participants in Phase 1 and 91 to 182 participants in Phase 2.
The Trial is divided into 2 Phases, (Phase 1 and 2). Both phases will have 21 days screening window.
Phase 1-participants will be assigned to either Schedule A or Schedule B.
Participants in Schedule A will receive ALKS 4230 (study drug) every 7 days for 6 weeks. In Schedule B participants will receive ALKS 4230 every 21 days for 6 weeks.
If study drug ALKS 4230 is well tolerated,pembrolizumab will be added to participant's treatment regime at Day 43. Pembrolizumab will be administered every 3 weeks at 200 mg intravenously (IV).
Phase 2-is a dose-expansion phase subcutaneously SC (under the skin) ALKS 4230 administered at the recommended Phase 2 dose (RP2D) (determined from Phase 1) in combination with pembrolizumab
Phase 2 will enrol participants into 1 of 5 cohorts based on 4 specific tumour types and 1 specific tumor histology.
This is an open label study which means that all participants will be taking the study drugs only.
The end of the study will be the last participant’s last visit (or, if applicable, the last phone call with the Investigator during the Follow-up period) as indicated in the Schedule of Assessments.
The estimated duration of this trial is 5 years.
REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
20/NE/0018
Date of REC Opinion
14 Feb 2020
REC opinion
Further Information Favourable Opinion