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

  • STATUS
    Recruiting
  • End date
    Apr 26, 2025
  • participants needed
    91
  • sponsor
    Celgene
Updated on 29 April 2022
platelet count
antibiotics
cancer
lymphoma
hodgkin's disease
growth factor
lung cancer
conventional treatment
neutrophil count
blood transfusion
cancer treatment
primary cancer
follicular lymphoma
diffuse large b-cell lymphoma
b-cell lymphoma
solid tumor
solid neoplasm

Summary

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.

Details
Condition Lymphoma, Non-Hodgkin, Neoplasms
Treatment rifampicin, Itraconazole, CC-90011
Clinical Study IdentifierNCT02875223
SponsorCelgene
Last Modified on29 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Advanced or unresectable solid tumors including those who have progressed on (or not been able to tolerate due to medical comorbidities or unacceptable toxicity) standard anticancer therapy or for whom no other approved conventional therapy exists
Eastern Cooperative Oncology Group Performance Status of 0 to 1

Exclusion Criteria

Prior autologous stem cell transplant ≤ 3 months before first dose or those who have not recovered
Symptomatic or uncontrolled ulcers (gastric or duodenal), particularly those with a history of and/or risk of perforation and gastrointestinal tract hemorrhages
Impaired cardiac function or clinically significant cardiac diseases
Poor bone marrow reserve as assessed by Investigator
Refer to protocol defined exclusion criteria for parts C and D. Other protocol-defined
inclusion/exclusion criteria apply
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