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Trial details imported from ClinicalTrials.gov
Ethics application status
A Study of CS3006 in Subjects With Locally Advanced or Metastatic Solid Tumors
A Phase I, Open Label, Multiple Dose, Dose Escalation and Expansion Study to Investigate the Safety, Tolerability, PK and Antitumor Activities of the MEK Inhibitor CS3006 in Subjects With Locally Advanced or Metastatic Solid Tumors
Universal Trial Number (UTN)
Solid Tumor, Adult
Description of intervention(s) / exposure
Treatment: Drugs - CS3006
Experimental: CS3006 - Participants will receive CS3006 orally at specified dose on specified days
Treatment: Drugs: CS3006
In the dose escalation part, the dose levels will be escalated following a modified 3+3 dose escalation scheme.
In the dose expansion part, participants will receive CS3006 at specified dose level(s).
Intervention code 
Comparator / control treatment
Primary outcome 
Number of participants with adverse events
From the day of first dose to 30 days after last dose of CS3006
Key inclusion criteria
1. Subjects with histologically or cytologically confirmed advanced or metastatic solid
tumor(s) for which no effective standard therapy is available or tolerable.
2. ECOG performance status of 0 or 1.
3. Life expectancy =12 weeks.
4. Able to swallow and retain oral medication.
5. Subjects must have adequate organ function.
6. Use of effective contraception.
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
1. Subjects receiving anti-cancer therapy at the time of enrollment.
2. 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.
3. Receipt of any prior therapy with a MEK inhibitor.
4. Use of any investigational anti-cancer drug within 28 days before the first dose of
5. Current use of a prohibited medication or use during treatment of CS3006.
6. Current use of warfarin.
7. Any condition that will interfere significantly with the absorption, distribution,
metabolism, or excretion of drugs.
8. History of retinal vein occlusion (RVO) or central serous retinopathy (CSR).
9. Visible retinal pathology as assessed by ophthalmologic exam.
10. Intraocular pressure > 21mm Hg as measured by tomography.
11. Glaucoma diagnosed within one month prior to the first dose of CS3006.
12. Known brain metastasis or other CNS metastasis that is either symptomatic or
13. Primary malignancy of CNS.
14. Evidence of severe or uncontrolled systemic diseases.
15. Subjects with clinically significant cardiovascular disease.
16. QTc interval >= 450 msecs for male or >= 470 msecs for female
17. Known history of HIV.
18. Subjects with active Hepatitis B or C infection
19. History of immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs
chemically related to CS3006.
For more information regarding trial participation, please contact at
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment
Methods used to generate the sequence in which subjects will be randomised (sequence
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?
Statistical methods / analysis
Active, not recruiting
Reason for early stopping/withdrawal
Accrual to date
Recruitment hospital 
St Vincent's hospital - Sydney
Recruitment postcode(s) 
Primary sponsor type
Ethics application status
This is a multicenter, open label, dose escalation & expansion phase I study to evaluate the
clinical safety, tolerability, PK, and preliminary efficacy of CS3006.
Trial related presentations / publications