PF-06821497 Treatment Of Relapsed/Refractory SCLC, Castration Resistant Prostate Cancer, and Follicular Lymphoma

Summary

Objectives

This is an open label, multi center, Phase 1 dose escalation and dose expansion study of
PF-06821497 administered orally BID as a single agent or in combination with SOC to
patients with CRPC, SCLC, and FL. Part 1A will evaluate safety and target modulation of
PF-06821497 monotherapy in patients with SCLC, FL and CRPC. PF-06821497 will be
administered as monotherapy in patients with FL in Part 1B dose escalation and to
patients with CRPC in Part 1C dose escalation. For Part 2A (dose escalation combination
therapy), PF-06821497 will be administered in combination with SOC in patients with CRPC
and SCLC. For Part 2B (dose expansion), patients with mCRPC will be randomized (1:1
ratio) to receive either SOC or PF-06821497 in combination with SOC. Once safety and
adequate target modulation has been established in Part 1A, Parts 1B and 2A of the trial
will be initiated. Part 1C (monotherapy dose escalation) will determine the MTD of single
agent PF-06821497 in patients with mCRPC. Japan and China monotherapy cohorts will
evaluate the safety, antitumor activity and PK of single agent PF-06821497 in Japanese
and Chinese patients. Part 2A (escalation RP2D finding for combination) will determine
the MTD of the combination with SOC in patients with CRPC. Part 2B (dose expansion) will
assess the efficacy of PF-06821497 at the RP2D in combination with SOC in patients with
mCRPC in comparison to SOC alone. The study is currently enrolling Part 2B.