A Study of CPI-0209 in Patients With Advanced Solid Tumors and Lymphomas

Active:	Yes
Cancer Type:	Hematopoietic Malignancies Lymphoma Non-Hodgkin Lymphoma Solid Tumor Unknown Primary	NCT ID:	NCT04104776
Trial Phases:	Phase I Phase II	Protocol IDs:	0209-01 (primary) NCI-2020-01007
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Constellation Pharmaceuticals
NCI Full Details:	http://clinicaltrials.gov/show/NCT04104776

Summary

First-in-human, open-label, sequential dose escalation and expansion study of CPI-0209 in
patients with advanced solid tumors and lymphomas. CPI-0209 is a small molecule inhibitor
of EZH2.

Objectives

Emerging evidence suggests that EZH2 is overexpressed in many cancer types and has a
pivotal role in disease progression. This is a Phase 1/2, open-label, multi-center, FIH
study designed to evaluate the safety and tolerability and preliminary clinical activity
of CPI-0209, an EZH2/1 inhibitor as monotherapy in patients with advanced solid tumors
and lymphomas. Phase 1 is composed of a CPI-0209 Dose Escalation period in patients with
advanced tumors and aims to determine maximum tolerated dose (MTD) and/or recommended
Phase 2 dose (RP2D) of CPI-0209 as monotherapy in patients with advanced tumors.

Phase 2 is planned to evaluate safety and tolerability and antitumor activity of CPI-0209
in six disease-specific cohorts (M1 to M6). Patients in Cohorts M1, M2, M3, M5, and M6
will be enrolled at 10 to 29 patients per cohort, using a Simon 2-stage design. Cohort M4
will enroll up to 20 patients with lymphoma in a single-stage. The primary aim of Phase 2
part of the study is to evaluate the antitumor activity of CPI-0209, and characterize the
safety and tolerability of CPI-0209 as monotherapy in patients with selected tumors.

In Phase 2, two additional doses are planned to be evaluated in cohorts M2 and M3 in 2
stages: Stage 2a and Stage 2b. In Stage 2a approximately 20 patients will be enrolled per
cohort and will be randomized 1:1 to receive 2 prespecified dose levels of CPI-0209 once
daily. When protocol criteria for initiating Stage 2b will be fulfilled after completion
of Stage 2a, then Stage 2b will be opened for enrolment of additional 10 patients in one
or both dose arms in each of the two cohorts. Thus, up to 40 patients per cohort (M2 and
M3) could be enrolled.

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