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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Lymphoma, Non-Hodgkin, Neoplasms

Intervention / Treatment
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* Drug: CC-90011
* Drug: Rifampicin
* Drug: Itraconazole


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CC-90011 and Rifampicin<br> | Drug: CC-90011<br>* Specified dose on specified days<br>Drug: Rifampicin<br>* Specified dose on specified days<br>|
| Experimental: CC-90011 and Itraconazole<br> | Drug: CC-90011<br>* Specified dose on specified days<br>Drug: Itraconazole<br>* Specified dose on specified days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose-Limiting Toxicity (DLT) | Number of participants with DLT | Up to approximately 28 days | 
| Maximum tolerated dose (MTD) evaluated using the NCI CTCAE criteria |  | Up to approximately 28 days | 
| Maximum observed plasma concentration (Cmax) |  | Up to approximately 9 years | 
| Area under the plasma concentration-time curve (AUC) from time zero extrapolated to infinity (AUC0-∞) |  | Up to approximately 9 years | 
| AUC from time zero to the last quantifiable concentration (AUC0-t) |  | Up to approximately 9 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Benefit Rate (CBR) determined by response and stable disease rates by disease appropriate response criteria | Is defined as tumor responses (as assessed by the Investigators) of complete response (CR), partial response (PR) and durable stable disease (SD) (SD of ≥ 4 months duration) | Up to approximately 8 years | 
| Objective Response Rate (ORR) | Is defined as the percent of subjects whose best response is complete response (CR) or partial response (PR) | Up to approximately 8 years | 
| Progression-Free Survival (PFS) | Is defined as the time from the first dose of CC-90011 to the first occurrence of disease progression or death from any cause | Up to approximately 8 years | 
| Overall Survival (OS) | Is measured as the time from the first dose of CC-90011 to death due to any cause | Up to approximately 8 years | 
| Duration of Response (DOR) |  | Up to approximately 8 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Safety, CC-90011, Advanced unresectable solid Tumors, Low intermediate-grade lung neuroendocrine tumors (Typical and Atypical carcinoids), Neuroendocrine prostate cancer (NEPC), R/R Non-Hodgkin's Lymphomas