A Safety and Efficacy Study of CC-90011 in Combination With Nivolumab in Subjects With Advanced Cancers

Inclusion Criteria

Subjects must satisfy the following criteria to be enrolled in the study:

• Subject is ≥ 18 years of age at the time of signing the informed consent form (ICF).
• Subject with histological or cytological confirmation of extensive stage Small Cell Lung Cancer (ES SCLC) or Stage IIIb or IV squamous Non-Small Cell Lung Cancer (sqNSCLC)
• Subject has received 1 or 2 prior lines of therapies, defined as:
• Cohort A (SCLC, Immune Checkpoint Inhibitor naïve):
• At least 1 prior treatment including a platinum-based chemotherapy doublet
• A minimum of 3 cycles of platinum-based chemotherapy in first line treatment, unless stopped at 2 cycles due to treatment-related toxicity
• Cohort B (SCLC, ICI progressors):
• At least 1 prior first or second line treatment includes an ICI
• If treatment includes an ICI as maintenance therapy, at least 1 cycle of ICI in maintenance should have been completed
• At least 1 prior treatment including a platinum-based chemotherapy doublet
• A minimum of 3 cycles of platinum-based chemotherapy, with or without ICI, in first line treatment, unless stopped at 2 cycles due to treatment-related toxicity
• Subject must have progressed during ICI therapy, defined as unequivocal progression on or within 3 months of the last dose of ICI therapy (if no subsequent therapy)
• Cohort C (sqNSCLC, ICI progressors):
• At least 1 prior first or second line treatment includes an ICI
• If treatment includes an ICI as maintenance therapy, at least 1 cycle of ICI in maintenance should have been completed
• At least 1 prior treatment including a platinum-based chemotherapy doublet
• A minimum of 3 cycles of platinum-based chemotherapy, with or without an ICI, in first line treatment, unless stopped at 2 cycles due to treatment-related toxicity
• Subject must have progressed during ICI therapy, defined as unequivocal progression on or within 3 months of the last dose of ICI therapy (if no subsequent therapy)
• Subject has progressed at the last line of therapy.
• Subject has a measurable disease defined by RECIST v1.1.
• Subject agrees to provide a tumor biopsy from primary or metastatic site prior to first dose and at a pre-specified timepoint during treatment. Core biopsy is required however, in the event a core biopsy may not otherwise be feasible in the opinion of the treating physician, an endobronchial ultrasound-guided fine needle aspirate [EBUS-FNA]) biopsy, using the largest gauge needle, may be performed instead.
• Subject has ECOG Performance Status of 0 to 1.
• Subject must have the following laboratory values:
• Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
• Hemoglobin (Hgb) ≥ 9 g/dL (one-time blood transfusion is allowed)
• Platelet (Plt) Count ≥ 150 x 109/L
• White blood cells (WBC) ≥ 2 x 109L
• Serum AST/serum glutamic oxaloacetic transaminase (SGOT) or ALT/serum glutamic pyruvic transaminase (SGPT) ≤ 3 x upper limit of normal (ULN) or ≤ 5 x ULN if presence of liver metastases
• Total serum bilirubin ≤ 1.5 x ULN (≤ 3 x ULN, if Gilbert's syndrome or if indirect bilirubin concentrations are suggestive of extrahepatic source of the elevation)
• Creatinine clearance (CrCl) ≥ 60 mL/minute based on Cockcroft-Gault or modification of diet in renal disease (MDRD) or ≥ 60 mL/min/1.73 m2

Exclusion Criteria

The presence of any of the following will exclude a subject from enrollment:

• Subject has not recovered to Grade 2 or lower clinically significant toxicities related to the prior therapy (alopecia excluded).
• Subject has received prior LSD1 therapies.
• Subject has a history of severe hypersensitivity reactions to other monoclonal antibodies
• Subject with symptomatic and untreated or unstable central nervous system (CNS) metastases.
• Subject has recently been treated with whole brain radiation or stereotactic radiosurgery for CNS metastases must have completed therapy at least 2 weeks prior to Cycle 1 Day 1 and has a follow-up brain computed tomography (CT) or