Gastric CancerPhase 1NCT04149691
Safety, Tolerability and Pharmacokinetics of Oral CPL304110, in Adult Subjects With Advanced Solid Malignancies
A Phase 1 study testing CPL304110 in people with Gastric Cancer and Bladder Cancer, run by Celon Pharma SA at 7 sites in Poland.
Trial 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 more about this study
- Who is it for?
- Ages 25 years and older
- Conditions the study is for
- Gastric Cancer, Bladder Cancer, Squamous Non-small Cell Lung Cancer
- What is being tested?
- CPL304110
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 7 sitesPoland
- Study dates
- 19 Jul 2019to 23 Jan 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
- 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
Who cannot join
- 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,
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- 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.
- Part 2 and 3
- No FFPE tumour sample available to conduct FGFR alteration eligibility tests and no biopsy option.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Poland7 sites
Uniwersyteckie Centrum Kliniczne w Gdańsku
Gdansk
BioResearch Group sp. z o.o.
Nadarzyn
SP ZOZ MSWiA z Warmińsko-Mazurskim Centrum Onkologii w Olsztynie
Olsztyn
Klinika Onkologii, Europejskie Centrum Zdrowia
Otwock
Centrum Onkologii - Instytut im. Marii Skłodowskiej-Curie
Warsaw
Instytut Gruźlicy i Chorób Płuc
Warsaw
Wojskowy Instytut Medyczny
Warsaw
About this study
Official title: 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
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).
- Conditions
- Gastric Cancer, Bladder Cancer, Squamous Non-small Cell Lung Cancer, Cholangiocarcinoma, Sarcoma, Endometrial Cancer
- Being tested
- CPL304110
- Keywords
- FGFR, kinase inhibitor, advanced solid tumors, carcinoma, neoplasms, gastric cancer, bladder cancer, squamous non-small cell lung cancer, squamous immunophenotype
- Medical subject headings
- Stomach Neoplasms, Urinary Bladder Neoplasms, Cholangiocarcinoma, Sarcoma, Endometrial Neoplasms, Carcinoma, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPL304110Drug
Also called PG19
CPL304110 is to be administered orally as hard gelatine capsules once daily in 28-day cycles.
| Study group | Role | What they receive |
|---|---|---|
| CPL304110 | Experimental | CPL304110 will be administered once daily to adults with advanced solid malignancies in 28-day cycles. Receives: Drug: CPL304110 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: First cycle of 28 days
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.
Measured: First cycle of 28 days
Secondary outcomes (8)
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.
Measured: Approximately up to 12 months
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.
Measured: Approximately up to 12 months
Maximum plasma concentration (Cmax)
Cmax defines the maximum concentration of the product in plasma during observation period.
Measured: up to 24 hours after CPL304110 administration
Time to maximum plasma concentration (tmax)
tmax defines Time to reach maximum plasma concentration
Measured: up to 24 hours after CPL304110 administration
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
Measured: up to the time of last quantifiable concentration after CPL304110 administration
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
Measured: up to 24 hours after CPL304110 administration
Terminal half-life (t½)
Plasma elimination half-life
Measured: up to 24 hours after CPL304110 administration
Kel: Terminal elimination rate constant
Terminal elimination rate constant
Measured: up to 24 hours after CPL304110 administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2019
- Study start19 Jul 2019
- Primary completion23 Jan 2025
- Study completion23 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celon Pharma SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Center for Research and Development, Poland
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04149691
- Sponsor's protocol ID
- 01FGFR2018
- Status last verified
- Oct 2026
- First submitted
- 31 Oct 2019
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04149691
- Acronym / sponsor ID
- 01FGFR2018
- Conditions
- Gastric Cancer, Bladder Cancer, Squamous Non-small Cell Lung Cancer, Cholangiocarcinoma, Sarcoma, Endometrial Cancer
- Keywords
- FGFR, kinase inhibitor, advanced solid tumors, carcinoma, neoplasms, gastric cancer, bladder cancer, squamous non-small cell lung cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Celon Pharma SAIndustry (pharma, biotech, devices)
- Collaborators
- National Center for Research and Development, Poland
- Study start
- 19 Jul 2019 (actual)
- Primary completion
- 23 Jan 2025 (actual)
- Study completion
- 23 Jan 2025 (actual)
- First posted
- 4 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CPL304110 | Experimental | Drug: CPL304110CPL304110 will be administered once daily to adults with advanced solid malignancies in 28-day cycles. |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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)
Key exclusion criteria (16 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CPL304110Also: PG19CPL304110 is to be administered orally as hard gelatine capsules once daily in 28-day cycles. | Drug | CPL304110 |
Primary outcome
Maximum tolerated dose (MTD)
Time frame: First cycle of 28 days
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.
Safety profile
Time frame: First cycle of 28 days
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.
8 secondary outcomes
Recommended Phase 2 Dose (RP2D) determined on the base of the MTD.
Time frame: Approximately up to 12 months
ORR, objective rate response
Time frame: Approximately up to 12 months
Maximum plasma concentration (Cmax)
Time frame: up to 24 hours after CPL304110 administration
Time to maximum plasma concentration (tmax)
Time frame: up to 24 hours after CPL304110 administration
Area under the plasma concentration versus time curve (AUC) from 0 up to the time of last quantifiable concentration (AUC0-t)
Time frame: up to the time of last quantifiable concentration after CPL304110 administration
Area under the plasma concentration versus time curve AUC from 0 to infinity (AUC0-inf)
Time frame: up to 24 hours after CPL304110 administration
Terminal half-life (t½)
Time frame: up to 24 hours after CPL304110 administration
Kel: Terminal elimination rate constant
Time frame: up to 24 hours after CPL304110 administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Derived from this study: PubMed 33199155Yamani 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CPL304110 in people with Gastric Cancer and Bladder Cancer, run by Celon Pharma SA at 7 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose (MTD) (time frame: First cycle of 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04149691, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.