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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.
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.