Clinical Trial Finder

Inclusion Criteria:

• - Patient or legal guardian, if permitted by local regulatory authorities, provides informed consent to participate in the study must be performed before any procedure's protocol related.

• - age of ≥25 years old.

• - Performance Score ≥70 in accordance with the Karnofsky Performance Score (KPS), - life expectancy period of at least 3 months on the screening day, - Have measurable disease according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) - subject (or his/her partner) of childbearing potential willingness to use acceptable forms of contraception.

• - adequate blood, liver, renal and urine parameters.

• - phosphate levels within normal range.

• - HIV, HCV (hepatitis C virus) and HBV negative (hepatitis B virus), - adequate cardiac function.

Inclusion Criteria Specific for parts: Part 1.

• - Patients with histologically confirmed advanced gastric cancer, bladder cancer, squamous lung cancer or non-small cell lung cancer with squamous immunophenotype, cholangiocarcinoma, sarcoma or endometrial cancer, be refractory to prior therapies and without effective further treatment options.

Part 2 and 3.

• - Patients with histologically confirmed advanced gastric cancer, bladder cancer, squamous lung cancer or non-small cell lung cancer with squamous immunophenotype, be refractory to prior therapies and without effective further treatment options.

• - Subject's archival formalin-fixed paraffin-embedded (FFPE) tumour sample available for molecular alteration diagnostics, and/or a possibility to collect a new biopsy.

• - Present molecular alteration within FGFR 1, 2 or 3.

Exclusion Criteria:

• - Any other current malignancy or malignancy diagnosed within the past five (5) years.

• - Active brain metastases or leptomeningeal metastases.

• - concurrent anticancer treatment within 28 days before the start of trial treatment; major surgery within 28 days before the start of trial treatment); use of blood transfusion within 7 days before the start of trial treatment, - prior therapy with an agent directed to another FGFR inhibitor, - pregnancy and/or breastfeeding, - phosphate levels above the upper limit of normal, - ectopic calcification/mineralization, - endocrine alteration related to calcium/phosphate homeostasis e.g. parathyroid disorders, history of parathyroidectomy, - concomitant therapies increasing calcium/phosphate serum levels, - inability to take oral medicines, - corneal disorder and/or keratopathy, - persisting toxicity related to prior therapy Grade > 1 CTCAE v5.0, except polyneuropathy and alopecia, - clinically significant (i.e., active) cardiovascular disease.

History of abdominal fistula, bowel obstruction (Grade IV), gastrointestinal perforation, intra-abdominal abscess within 6 months of enrollment. Other significant diseases, which, in the opinion of the investigator, might impair the subject's tolerance of trial treatment.

• - Receipt of any organ transplantation including allogeneic stem-cell transplantation.

Exclusion Criteria Specific for parts: Part 2 and 3.

• - No FFPE tumour sample available to conduct FGFR alteration eligibility tests and no biopsy option.

01FGFR2018 is an Open-label, Multicentre, Dose Escalation Study to Assess Safety, Tolerability and Pharmacokinetics of Oral CPL304110, in Adult Subjects with Advanced Solid Malignancies. The study consists of 3 parts: initial dose escalation (Part 1

• - without FGFR, fibroblast growth factor receptor, molecular aberrations), dose escalation (Part 2 - with FGFR molecular aberrations) and dose extension (Part 3 - with FGFR molecular aberrations).

Arms

Experimental: CPL304110

CPL304110 will be administered once daily to adults with advanced solid malignancies in 28-day cycles.

Interventions

Drug: - CPL304110

CPL304110 is to be administered orally as hard gelatine capsules once daily in 28-day cycles.