Phase 1b/2a, open-label, sequential dose escalation and expansion study of AMG 232 in
combination with trametinib and dabrafenib in subjects with metastatic melanoma followed
by a direct comparison of AMG 232 combined with trametinib and dabrafenib versus
trametinib combined with dabrafenib alone.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02110355.
The study will be conducted in 3 parts: Part 1 - Dose Escalation, Part 2 - Dose Expansion
and Part 3, a randomized Phase 2a.
In both part 1 and 2, subjects will be enrolled open-label into 1 of 2 arms. For both Arm
1 and Arm 2, the part 1 dose escalation is aimed at determining an AMG 232 maximum
tolerated dose (MTD) with a fixed dose of the combination drug(s) and evaluating safety,
tolerability, pharmacokinetics and pharmacodynamics of each combination. Part 2 dose
expansion will enroll subjects to receive therapy with a dose and schedule of AMG 232
selected from the corresponding part 1 dose escalation. In part 2 subjects will be
enrolled to confirm safety and tolerability and to assess clinical activity prior to
proceeding to Part 3, Phase 2a. In Phase 2a, Subjects will be randomized open-label in a
1:1 ratio to receive AMG 232 in combination with trametinib plus dabrafenib versus
trametinib plus dabrafenib alone.
Only Part 1 of the study was enrolled and the study did not proceed into Phase 2.
Lead OrganizationKartos Therapeutics, Inc.
