Last updated on January 2020

A Safety and Efficacy Study of CC-90011 in Subjects With Relapsed and/or Refractory Solid Tumors and Non-Hodgkin's Lymphomas

Brief description of study

Study CC-90011-ST-001 is an open-label, Phase 1, dose escalation and expansion, First-In-Human (FIH) clinical study of CC-90011 in subjects with advanced unresectable solid tumors (enriched for grade 2 NENs, grade 2 NETs and NECs) and R/R NHL (MZL, including transformed MZL). The dose escalation part (Part A) of the study will explore escalating oral doses of CC-90011 to estimate the maximum tolerated dose (MTD) of CC-90011. The expansion part (Part B) will further evaluate the safety and efficacy of CC-90011 administered at or below the MTD in 3 selected expansion cohorts of approximately 10-20 evaluable subjects each, in order to further define the RP2D.

Detailed Study Description

Parts A and B will consist of 3 periods: Screening, Treatment and Follow-up. Screening Period The Screening Period starts 28 days ( 3 days) prior to first dose of CC-90011. The informed consent form (ICF) must be signed and dated by the subject and the administering staff prior to the start of any other study procedures. All screening tests and procedures must be completed within the 28 days (3 days) prior to the first dose of CC-90011.

Treatment Period During the Treatment Period, CC-90011 will initially be administered orally in each 4-week (28 day) Cycle in Part A.

In September 2018, after completion of Part A, the SRC determined the RP2D to be 60 mg CC 90011 once weekly (QW) in each 28-day cycle. In Part B, 3 cohorts, of approximately 10-20 evaluable subjects each, with advanced low/intermediate-grade lung NETs, NEPCs, R/R NHL (MZL, including transformed MZL) will receive the RP2D to further evaluate safety, PK, PD and preliminary efficacy.

Follow-up Period In the Follow-up Period, subjects will be followed for 28 days ( 3 days) after the last dose of CC-90011 for safety.

After the Safety Follow-up visit, all subjects will be followed every subsequent 3 months ( 2 weeks) for survival follow-up for up until 2 years or until death, lost to follow-up, or the End of Trial, whichever occurs first.

Clinical Study Identifier: NCT02875223

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