A Study of LUT014 in Patients With Metastatic Colorectal Cancer With EGFR Inhibitor Induced Acneiform Lesions

Inclusion Criteria:

- Diagnosed with mCRC;

- Currently being treated with an FDA approved EGFRI for the treatment of mCRC,
including but not limited to Erbitux® (cetuximab) Injection and Vectibix®
(panitumumab) Injection, as directed by the approved labeling;

- Treatment with the FDA approved EGFRI initiated within 4 weeks prior to the Screening
Visit;

- Grade 1 or 2 acneiform lesions at the Screening and Baseline (Day 0) Visits;

- Age ≥18 years at the time of signing the informed consent form (ICF);

- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2;

- Expected life expectancy greater than 3 months;

- Subject can understand and sign the ICF, can communicate with the Investigator, can
understand and comply with the requirements of the protocol, and can apply the study
drug by himself/herself or has a care giver that can apply the drug;

- Women of childbearing potential (WCBP) must have a negative serum pregnancy test at
Screening and a negative urine pregnancy test at baseline (Day 0);

- WCBP must agree to abstain from sex or use an adequate method of contraception from
the time of informed consent through the Day 55 Visit and for 90 days after the last
dose of study drug (LUT014);

- Males must abstain from sex with WCBP or use an adequate method of contraception from
the time of informed consent through the Day 55 Visit and for 90 days after the last
dose of study drug (LUT014).

Exclusion Criteria:

- Active infection;

- Significant skin disease other than EGFRI induced acneiform lesions;

- Any cancer other than mCRC within 3 years of Screening;

- Any condition which, in the opinion of the Investigator, places the subject at
unacceptable risk if he/she were to participate in the study;

- Clinically relevant serious co-morbid medical conditions including, but not limited
to, unstable angina, symptomatic congestive heart failure, uncontrolled hypertension,
uncontrolled cardiac arrhythmias, chronic obstructive or chronic restrictive pulmonary
disease, active central nervous system (CNS) disease uncontrolled by standard of care,
known positive status for human immunodeficiency virus (HIV) and/or active hepatitis B
or C, cirrhosis, or psychiatric illness/social situations that would limit compliance
with study requirements;

- Pregnant or lactating;

- Treatment with an EGFRI other than those specified in the inclusion criteria within 30
days or 5 half-lives of the drug prior to Screening, whichever is longer;

- Treatment with a serine/threonine-protein kinase B-Raf (B-Raf) inhibitor, including
but not limited to Zelboraf® (vemurafenib), Tafinlar® (dabrafenib), BraftoviTM
(encorafenib), and Nexavar® (sorafenib), within 30 days or 5 half-lives of the drug
prior to Screening, whichever is longer;

- Treatment with a systemic antibiotic within 7 days prior to Screening;

- Treatment with a systemic corticosteroid or treatment with a topical corticosteroid to
the face, neck, or upper portion of the anterior or posterior chest within 14 days
prior to Screening;

- Treatment with another investigational drug within 30 days or 5 half-lives of drug
prior to Screening, whichever is longer;

- Known hypersensitivity to the inactive ingredients of the study drug (LUT014).