Safety and PK Study of CC-90003 in Relapsed/Refractory Solid Tumors

CC-90003-ST -001 is an open-label, multicenter, Phase 1a study in subjects with
locally-advanced or metastatic, solid tumors who are intolerant of, resistant to, or have
relapsed after at least one line of therapy and for whom no standard therapy exists. The
study will be conducted in two parts: Dose Escalation (Part 1) and Cohort Expansion (Part
2). Subjects may continue CC-90003 until progression of their underlying malignancy, the
occurrence of intolerable toxicity, or physician/subject decision to discontinue CC-90003.
In Part 1, cohorts of subjects with relapsed or refractory solid tumors will receive
increasing doses of CC-90003 in order to assess its safety and tolerability, the maximum
tolerated dose (MTD), and PK profile. In Part 2, cohorts of subjects with specific tumors
that harbor mutations involving the Mitogen -Activated Protein Kinase (MAPK) pathway will
receive CC-90003 at or below the MTD until progression of disease, intolerable toxicity, or
physician/subject decision to discontinue CC-90003.

Inclusion Criteria:

1. Eligible study subjects in Part 1 and Part 2 must be 18 years or older

2. Eligible study subjects must have histologic or cytologic confirmation of advanced,
unresectable or metastatic solid tumors, and have at least one measurable lesion per
Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1

3. Eligible study subjects must have Eastern Cooperative Oncology Group Performance
Status (ECOG PS) of 0 or 1

4. Eligible study subjects must exhibit acceptable liver, bone marrow, renal and cardiac
functions as assessed by laboratory tests, ECG and ECHO or MUGA scan.

Exclusion Criteria:

1. Subjects with symptomatic or unstable CNS metastases

2. Subjects with a history of recent (within 28 days) systemic therapy for their
underlying malignancy

3. Subjects who have had surgery/radiotherapy within 2 weeks prior to start of study