Last updated on April 2019

A Study to Assess the Safety Tolerability Pharmacokinetics and Preliminary Efficacy of CC-90010 in Subjects With Advanced Solid Tumors and Relapsed/Refractory Non-Hodgkin's Lymphomas

Brief description of study

Study CC-90010-ST-001 is an open-label, Phase 1a, dose escalation and expansion, First-in-human (FIH) clinical study FORM-GWP-DSD-001A Protocol Number {CC-90010-ST-001} Page 6 of CC-90010 in subjects with advanced or unresectable solid tumors and relapsed and/or refractory advanced Non-Hodgkin's lymphoma (NHL). The dose escalation part (Part A) of the study will explore escalating oral doses of CC-90010 to estimate the maximum tolerated dose (MTD) of CC-90010. The expansion part (Part B) will further evaluate the safety and efficacy of CC-90010 administered at or below the MTD, as monotherapy or in combination with CC-122, in selected expansion cohorts of approximately 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-90010. The informed consent document (ICD) 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-90010.

Treatment Period:

During the Treatment Period, CC-90010 will initially be administered orally once daily for 3 consecutive days followed by 4 consecutive days off in each 28-day cycle. Alternative dosing schedules (eg, 2-days- on/5-days- off each week, 3-days-on/4-days-off every other week, 2-weeks-on/2-weeks-off, 4-days on/24 days off, 5-days on/23-days- off, etc.) may be evaluated one dosing schedule at a time or 2 dosing schedules given in parallel, based on the review of available safety, PK, pharmacodynamic (PD), and efficacy data by the SRC. Following completion of dose escalation in Part A, selected expansion cohorts of up to approximately 20 efficacy evaluable subjects per cohort will receive CC-90010 alone or in combination with CC-122 in Part B. Expansion may occur at the MTD established in Part A and/or at a lower dose, or an alternative tolerable dosing schedule, based on review of available safety, PK, and PD data. Part B expansion cohorts will include relapsed and/or refractory DLBCL (Cohort 1), advanced basal cell carcinoma (BCC), advanced NUT midline carcinoma. advanced salivary gland carcinoma as well as advanced endometrial carcinoma (Cohort 2). Part B will evaluate the safety and preliminary efficacy of CC-90010 in combination with CC-122 in subjects with relapsed and/or refractory DLBCL (Cohort 3), after confirmation of the CC-90010 combination dose/schedule on a small cohort of relapsed and/or refractory DLBCL subjects.

Follow-up Period:

In the Follow-up Period, subjects will be followed for 28 days ( 3 days) after the last dose of CC-90010 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: NCT03220347

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Recruitment Status: Open

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