Evaluating the safety and tolerability of CPL304110 in adults with advanced solid tumors
A Phase I, Open-label, Multicentre, Dose Escalation Study to Assess Safety, Tolerability and Pharmacokinetics of Oral CPL304110, in Adult Subjects With Advanced Solid Malignancies
This study is testing a new oral medication called CPL304110 to see if it's safe and how well it works for adults with advanced solid tumors.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 42 (estimated) |
| Ages | 25 Years and up |
| Sex | All |
| Sponsor | Celon Pharma SA Industry-sponsored |
| Locations | 7 sites (Gdańsk and 6 other locations) |
| Trial ID | NCT04149691 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the safety, tolerability, and pharmacokinetics of CPL304110, an oral medication, in adult patients with advanced solid malignancies. It is an open-label, multicenter, dose escalation study divided into three parts: the initial dose escalation for patients without FGFR molecular aberrations, followed by dose escalation and extension for those with FGFR aberrations. The study will monitor participants for adverse effects and how the drug is processed in the body.
Who should consider this trial
Good fit: Ideal candidates include adults aged 25 and older with advanced gastric cancer, bladder cancer, squamous non-small cell lung cancer, or cholangiocarcinoma.
Not a fit: Patients with early-stage cancers or those without the specified types of advanced solid malignancies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients with advanced solid tumors, potentially improving their outcomes.
How similar studies have performed: Other studies involving FGFR inhibitors have shown promise, indicating that this approach may be beneficial.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Gdańsk and 6 other locations
- Uniwersyteckie Centrum Kliniczne w Gdańsku — Gdańsk, Poland (Recruiting)
- BioResearch Group sp. z o.o. — Nadarzyn, Poland (Recruiting)
- SP ZOZ MSWiA z Warmińsko-Mazurskim Centrum Onkologii w Olsztynie — Olsztyn, Poland (Recruiting)
- Klinika Onkologii, Europejskie Centrum Zdrowia — Otwock, Poland (Not_yet_recruiting)
- Centrum Onkologii - Instytut im. Marii Skłodowskiej-Curie — Warsaw, Poland (Recruiting)
- Instytut Gruźlicy i Chorób Płuc — Warsaw, Poland (Recruiting)
- Wojskowy Instytut Medyczny — Warsaw, Poland (Not_yet_recruiting)
Study contacts
- Study coordinator: Cros Cro
- Email: clinicaltrials@cros-cro.com
- Phone: +48 791 690 990
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.