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RecruitingNCT04149691Updated Feb 7, 2024

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

A Phase 1 interventional study of CPL304110 in Gastric Cancer, Bladder Cancer and Squamous Non-small Cell Lung Cancer, sponsored by Celon Pharma SA. Recruiting at 7 sites in Poland. Open to participants aged 25 Years and older. Per ClinicalTrials.gov, last updated 2024-02-07.

Sponsored by Celon Pharma SA · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2024, 2 years 4 months ago, but the record still lists the study as recruiting.
  • Registered 3 months after the study started (first participant enrolled Jul 2019, registered Oct 2019).
  • Started Jul 2019; still recruiting 7 years 2 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
42
Allocation
Not applicable
Ages
25 Years and older
Sex
All
01

Study 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.

Read the detailed description

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).

02

Conditions studied

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

Keywords

  • FGFR
  • kinase inhibitor
  • advanced solid tumors
  • carcinoma
  • neoplasms
  • gastric cancer
  • bladder cancer
  • squamous non-small cell lung cancer
  • squamous immunophenotype
03

In context

Carcinoma, Non-Small-Cell Lung

6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.

This study's planned enrollment of 42 is below the median of 62 across 5,213 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.

Browse Carcinoma, Non-Small-Cell Lung studies →

Lead sponsor

Celon Pharma SA is the lead sponsor of 11 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
42 participants (estimated)

Study arms

  • Experimental
    CPL304110

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

    Drug: CPL304110

Interventions

  • DrugCPL304110

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

    Also known as: PG19

06

What researchers measure

Primary outcomes

  1. Maximum tolerated dose (MTD)

    Maximum tolerated dose (MTD) of CPL304110 when administered orally once daily to adults with advanced solid malignancies. The MTD is the highest dose associated with the occurrence of dose-limiting toxicities (DLTs) in \<33% of patients.

    Time frame: First cycle of 28 days

  2. Safety profile

    Overall safety profile of CPL304110, as assessed by the type, frequency, severity, timing, and relationship to study drug of any adverse events (AEs), serious adverse events (SAEs), and changes in vital signs, ECGs, and safety laboratory test.

    Time frame: First cycle of 28 days

Secondary outcomes

  1. Recommended Phase 2 Dose (RP2D) determined on the base of the MTD.

    The RP2D will be determined after review and discussion of the pharmacokinetics (PK) profile, type and severity of drug related toxicity and clinical suitability for long-term administration.

    Time frame: Approximately up to 12 months

  2. ORR, objective rate response

    ORR, objective rate response defined as the rate of confirmed complete response (CR) or partial response (PR) by RECIST 1.1.

    Time frame: Approximately up to 12 months

  3. Maximum plasma concentration (Cmax)

    Cmax defines the maximum concentration of the product in plasma during observation period.

    Time frame: up to 24 hours after CPL304110 administration

  4. Time to maximum plasma concentration (tmax)

    tmax defines Time to reach maximum plasma concentration

    Time frame: up to 24 hours after CPL304110 administration

  5. Area under the plasma concentration versus time curve (AUC) from 0 up to the time of last quantifiable concentration (AUC0-t)

    AUC(0-t) defines the area under the curve of plasma concentration vs time, from time point zero up to the time of last quantifiable concentration

    Time frame: up to the time of last quantifiable concentration after CPL304110 administration

  6. Area under the plasma concentration versus time curve AUC from 0 to infinity (AUC0-inf)

    AUC0-inf defines the area under the curve of plasma concentration vs time, from time point zero extrapolated to infinity

    Time frame: up to 24 hours after CPL304110 administration

  7. Terminal half-life (t½)

    Plasma elimination half-life

    Time frame: up to 24 hours after CPL304110 administration

  8. Kel: Terminal elimination rate constant

    Terminal elimination rate constant

    Time frame: up to 24 hours after CPL304110 administration

07

Study locations

5 of 7 sites recruiting
  • 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
08

References and documents

Publications

  • Yamani A, Zdzalik-Bielecka D, Lipner J, Stanczak A, Piorkowska N, Stanczak PS, Olejkowska P, Hucz-Kalitowska J, Magdycz M, Dzwonek K, Dubiel K, Lamparska-Przybysz M, Popiel D, Pieczykolan J, Wieczorek M. Discovery and optimization of novel pyrazole-benzimidazole CPL304110, as a potent and selective inhibitor of fibroblast growth factor receptors FGFR (1-3). Eur J Med Chem. 2021 Jan 15;210:112990. doi: 10.1016/j.ejmech.2020.112990. Epub 2020 Nov 7. PubMed 33199155 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 7, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04149691
Lead sponsor
Celon Pharma SA
Collaborators
National Center for Research and Development, Poland
Responsible party
Sponsor
First posted
Nov 4, 2019
Start date
Jul 19, 2019
Primary completion
Jun 2024 (estimated)
Completion
Jun 2024 (estimated)
Last update
Feb 7, 2024

Study contacts

CROS CRO
Contact
clinicaltrials@cros-cro.com
+48 791 690 990

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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