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A Phase 1, Open-label, Dose Finding Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of CC-90011 in Subjects With Relapsed and/or Refractory Solid Tumors and Non-Hodgkin's Lymphomas
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 extranodal MZL \[EMZL\], splenic MZL \[SMZL\], nodal MZL \[NMZL\], and histologic transformation of 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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Local Institution - 101
Dijon, France
Local Institution - 102
Marseille, France
Local Institution - 100
Villejuif, France
Local Institution - 200
Bologna, Italy
Local Institution - 201
Milan, Italy
Local Institution - 202
Milan, Italy
Local Institution - 501
Chuo-ku, Tokyo, Japan
Local Institution - 502
Koto-Ku, Tokyo, Japan
Local Institution - 500
Kashiwa, Japan
Local Institution - 400
Barcelona, Spain
Start Date
August 31, 2016
Primary Completion Date
March 25, 2024
Completion Date
March 25, 2024
Last Updated
April 20, 2025
75
ACTUAL participants
CC-90011
DRUG
Rifampicin
DRUG
Itraconazole
DRUG
Lead Sponsor
Celgene
NCT07169851
NCT07213804
Data Source & Attribution
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Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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