A Study of CS3006 in Subjects with Locally Advanced or Metastatic Solid Tumors

Inclusion criteria

• Subjects with histologically or cytologically confirmed advanced or metastatic solid tumor(s) for which no effective standard therapy is available or tolerable.
• ECOG performance status of 0 or 1.
• Life expectancy ≥12 weeks.
• Able to swallow and retain oral medication.
• Subjects must have adequate organ function.
• Use of effective contraception.

Exclusion criteria

• Subjects receiving anti-cancer therapy at the time of enrollment.
• Subjects who had prior chemotherapy, targeted therapy, immunotherapy or any other systemic anti-cancer treatment, within 14 days prior to the first dose of CS3006 or who has not recovered from adverse events due to a prior therapy.
• Receipt of any prior therapy with a MEK inhibitor.
• Use of any investigational anti-cancer drug within 28 days before the first dose of CS3006.
• Current use of a prohibited medication or use during treatment of CS3006.
• Current use of warfarin.
• Any condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of drugs.
• History of retinal vein occlusion (RVO) or central serous retinopathy (CSR).
• Visible retinal pathology as assessed by ophthalmologic exam.
• Intraocular pressure > 21mm Hg as measured by tomography.
• Glaucoma diagnosed within one month prior to the first dose of CS3006.
• Known brain metastasis or other CNS metastasis that is either symptomatic or untreated.
• Primary malignancy of CNS.
• Evidence of severe or uncontrolled systemic diseases.
• Subjects with clinically significant cardiovascular disease.
• QTc interval >= 450 msecs for male or >= 470 msecs for female
• Known history of HIV.
• Subjects with active Hepatitis B or C infection
• History of immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to CS3006.

For more information regarding trial participation, please contact at [email protected]