Brief Title: Safety, Tolerability and Pharmacokinetics of Oral CPL304110, in Adult Subjects With Advanced Solid Malignancies

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Maximum tolerated dose (MTD)

Primary Outcome 1 - Timeframe: First cycle of 28 days

Primary Outcome 2 - Measure: Safety profile

Primary Outcome 2 - Timeframe: First cycle of 28 days

CONDITION

• Gastric Cancer
• Bladder Cancer
• Squamous Non-small Cell Lung Cancer
• Cholangiocarcinoma
• Sarcoma
• Endometrial Cancer
• Other Solid Tumours

ELIGIBILITY

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.

Gender: All

Minimum Age: 25 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: N/A

Role: N/A

Affiliation: N/A

Overall Contact

Name: CROS CRO

Phone: +48 791 690 990

Email: [email protected]

LOCATION