A Phase 1 Study of AMG 757 in Participants with Small Cell Lung Cancer
Research type
Research Study
Full title
A Phase 1 Study Evaluating the Safety, Tolerability and Pharmacokinetics of AMG 757 in Subjects With Small Cell Lung Cancer
IRAS ID
234495
Contact name
Fiona Blackhall
Contact email
Sponsor organisation
Amgen Ltd
Eudract number
2017-003421-15
Clinicaltrials.gov Identifier
BB-IND 134859, IND Number
Duration of Study in the UK
3 years, 9 months, 19 days
Research summary
This is an open-label, ascending, multiple dose, phase 1 study evaluating AMG 757
administered as a short term intravenous (IV) infusion every 2 weeks (with or without
Day 8 step dosing) in subjects with small cell lung cancer.
The study will consist of 2 parts. Part A will evaluate subjects with RR SCLC who progressed after at least 1 platinum-based chemotherapy regimen. This Part A is comprised of 2 phases: Dose Exploration and Dose Expansion phases.
The second Part B will evaluate subjects with Extended Disease (ED) SCLC with ongoing clinical benefit following no more than 4 cycles of platinum-based chemotherapy. Part B will commence once Maximum Tolerated Dose (MTD) or recommended phase 2 dose (RP2D) is identified in Part A.
Dose exploration will be conducted in two stages: single-subject cohort(s) followed by multiple subject cohort(s) (3-4 subjects per cohort). Dose escalating single-subject cohorts will be initially enrolled at dose levels anticipated to be lower than those at which adverse events or efficacy is expected to be observed. The single subject cohort will expand to a multiple-subject cohort once
either clinically significant treatment-related AE of grade ≥ 2 or objective response (whichever occurs earlier) is observed.REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
17/NE/0363
Date of REC Opinion
27 Feb 2018
REC opinion
Further Information Favourable Opinion