FGFR Inhibitor ET0111 Monotherapy in Patients With Advanced Solid Tumors

Inclusion Criteria:

1. Provision of signed and dated, written informed consent prior to any study specificprocedures, sampling and analyses.
2. Aged at least 18 years at the time of ICF signature.
3. Histological or cytological confirmation of a solid tumor and have progressed despitestandard therapy(ies), or are intolerant to standard therapy (ies), or have a tumorfor which no standard therapy(ies) exists. Locally recurrent disease must not beamenable to surgical resection or radiotherapy with curative intent (patients who areconsidered suitable for surgical or ablative techniques following down-staging withstudy treatment are not eligible).
4. Estimated life expectancy of minimum of 12 weeks.
5. Patient with solid tumors must have at least 1 lesion, not previously irradiated, thatcan be accurately measured at pre-dose as ≥ 10 mm in the longest diameter (exceptlymph nodes which must have short axis ≥ 15 mm) with Computerised Tomography (CT) ormagnetic resonance imaging (MRI) and which is suitable for accurate repeatedmeasurements.
6. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 at ICF signature.
7. Males and Females of child-bearing potential must agree to use effective contraceptionfrom the time ICF signature until 12 weeks after the last dose. Females ofchildbearing potential include those who are premenopausal and those who are 2 yearspostmenopausal. Pregnancy tests for female of child-bearing potential must have anegative serum pregnancy test at Screening.

Exclusion Criteria:

1. Have a history and/or current evidence of extensive tissue calcification including,but not limited to, the soft tissue, kidneys, intestine, myocardium, vascular system,and lung with the exception of calcified lymph nodes, minor pulmonary parenchymalcalcifications, and asymptomatic coronary calcification..
2. Have current evidence of endocrine alterations of calcium/phosphate homeostasis, e.g.,parathyroid disorders, history of parathyroidectomy, tumor lysis, tumoral calcinosisetc.
3. As judged by the investigator, any evidence of significant ophthalmologicalabnormalities including but not limited to history or current evidence of retinal veinocclusion (RVO) or current risk factors for RVO, retinal macular degeneration,uncontrolled glaucoma, cataract or marked decrease in visual acuity, symptomaticsevere dry eye, conjunctivitis, or corneal ulcer. Prior bone marrow or organ transplantation
4. Central nervous system metastatic disease, leptomeningeal disease, or metastatic cordcompression.
5. Prior therapy with any irreversible FGFR inhibitor.