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

• Status: Recruiting
• Trial end date: 2021-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to determine to evaluate safety and tolerability of CPL304110 when administered once daily to adults with advanced solid malignancies.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Celon Pharma SA
• Collaborator: National Center for Research and Development, Poland

Criteria

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.