Solid TumorPhase 1NCT05212987
Study of FCN-098 in Patients With Advanced Solid Tumor
A Phase 1 study testing FCN-098 in people with Solid Tumor, run by Fochon Pharmaceuticals, Ltd. at 1 site in China.
Trial summary
A multi-center, open, single-arm phase I dose exploratory study to evaluate the safety, tolerability, pharmacokinetic characteristics and primary antitumor activity of FCN-098 in patients with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- FCN-098
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteChina
- Study dates
- 31 Dec 2021to 12 Oct 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Age ≥ 18 years，no gender limitation；
- 2. Patients with inoperable solid tumors, stage III or IV, confirmed histologically or cytologically by standard treatment failure or no standard treatment;
- 3. Dose-escalation stage: patients with advanced solid malignancies after failure of standard treatment (patients with positive NTRK gene fusion or mutations in the TRK kinase region are preferred); Dose expansion stage: patients with advanced solid malignant tumors with NTRK gene fusion positive or TRK kinase region mutation after standard treatment failure; NTRK gene fusion positive or TRK kinase region mutation can be included based on the positive report of the local laboratory, but tissues must be provided to the central laboratory for confirmation;
- 4. The ECOG Scores 0 or 1 for physical fitness (Dose-escalation stage),0-2(Dose expansion stage);
- 5. Can understand and be willing to sign informed consent prior to the commencement of any research procedure;
- 6. Expected survival at least 12 weeks;
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- 7. Patients with adequate organ and bone marrow function: absolute value of neutrophils ≥ 1.0 × 10^9/L (no G-CSF treatment within 7 days);Hemoglobin ≥ 80g/L (no erythrocyte infusion within 7 days);Platelet ≥ 75 × 10^9/L; Serum total bilirubin ≤ 1.5 × upper limit normal (ULN), and patients with Gilbert syndrome ≤3.0 × ULN. Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 2.5 × ULN; For patients with liver metastasis, AST and ALT should be ≤ 5 × ULN. Creatinine<1.5×ULN or Creatinine clearance was ≥ 60 ml/min in dose-escalation stage, and ≥ 45ml/min in dose expansion stage. Creatinine clearance was calculated by Cockroft - Gault formula. Albumin ≥ 3g/dL;
- 8. At least one evaluable lesion (Dose escalation stage) was assessed according to RECIST 1.1 or RANO criteria; According to RECIST 1.1 or RANO standard to evaluate, at least one measurable lesions (Dose expansion stage) (primary central nervous system tumors according to the standard definition RANO, needs to have one or more measurable lesions by MRI assessment, size for at least 10 mm or more, and appeared in two or more ≤ 5 mm thick section, the measure does not include cystic cavity.) The imaging evaluation should be completed within 28 days before enrollment, and the patient's hormone dosage should be stable for at least 5 days or more.
- 9. A fertile woman must have a negative serum pregnancy test within 28 days of the first study drug administration and agree to contraception between 28 days before the first study drug administration and 90 days after the last study drug administration; Male patients are required to undergo ligation or agree to contraception and refuse sperm donation from 7 days before the first dose to 30 days after the last dose; The failure rate of contraceptive methods<1% per year, such as double screen contraceptive methods, condoms, oral or injectable contraceptives.
Who cannot join
- 1. Patients who received targeted therapy or tyrosine kinase inhibitor therapy within 2 weeks or within 5 half-lives (whichever is shorter) before starting administration, and who received chemotherapy, major surgery, radiotherapy, Anti-tumor biopharmaceutical treatment, immunotherapy or clinical trials within 4 weeks or within 5 half-lives (which is shorter);
- 2. Uncontrolled or symptomatic brain metastases (asymptomatic or stably controlled CNS metastases and no hormone therapy within 2 weeks are allowed to be enrolled);Patients with spinal cord metastasis with symptoms of spinal cord compression;Primary CNS tumors were allowed to be enrolled.
- 3. The toxicity of previous anti-tumor therapy has not recovered (>NCI-CITCAE 5.0 level 2), neurotoxic reaction level 2, except hair loss;
- 4. Patients should use strong CYP3A4 inhibitors (except drugs permitted in Section 6.8), inducers or sensitive substrates and sensitive substrates of CYP2B6, CYP2C8, CYP2C6 at the same time;
- 5. Patients take drugs (mainly Ia, Ic, class III anti-arrhythmia drugs) that will prolong the QTc interval or have risk factors for extending the QTc interval;
- 6. Difficulty in swallowing, or having an absorbance syndrome, or other medical conditions that prevent the absorption of drugs through the intestinal tract, or affect the absorption of FCN-098;
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- 7. Cardiac function and disease meet one of the following conditions:
- screening period in research center 3 times of 12 lead ECG measurement, according to the instrument of QTc formula for calculating the average three times, QTc>470 ms for female and QTc>450 ms for male.
- continue uncontrolled hypertension, systolic blood pressure under antihypertensive treatment >150 mmHg, and/or diastolic pressure >100 mmHg.
- the American New York Heart Association (New York Heart Association, NYHA) classification of grade 3 or more congestive Heart failure;
- Arrhythmias of clinical significance, including but not limited to complete left bundle branch conduction anomaly, degree II atrioventricular block;
- within 6 months prior to screening of a history of heart attack or a stroke within three months.
- 8. Active bacterial, fungal or viral infections of clinical significance, including hepatitis B (hepatitis B virus surface antigen-positive with HBV DNA exceeding 1000 IU/ml or meet the criteria for active hepatitis B infection) or hepatitis C (HCV RNA positive), human immunodeficiency virus infection (HIV positive);
- 9. Suffered from a malignant tumor other than the selected indications in the past 5 years (other than fully treated cervical carcinoma in situ, non-melanoma basal cell or squamous epithelial cell skin cancer, local prostate cancer after radical operation, ductal carcinoma in situ after radical operation);
- 10. Women who are pregnant or breastfeeding. Any patient who becomes pregnant during the trial should withdraw from the study;
- 11.Rule out any situation that is not suitable for entry into the group. For example, it may cause confusion in research results, interfere with patients' participation in research procedures, or have a history of other diseases, treatments, or laboratory abnormalities, or current evidence that does not meet the clinical benefits of participating in the research. (Such as uncontrollable diabetes, active or uncontrollable infection, etc.).
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
夕春 胡, 13816110335, xchu2009@hotmail.com
About this study
Official title: A Multi-center, Open, Single-arm Phase I Dose Exploratory Study to Evaluate the Safety, Tolerability, Pharmacokinetic Properties and Primary Antitumor Activity of FCN-098 in Patients With Advanced Solid Tumors
A multi-center, open, single-arm phase I dose exploratory study to evaluate the safety, tolerability, pharmacokinetic characteristics and primary antitumor activity of FCN-098 in patients with advanced solid tumors.
Read the detailed description
This study is a multicenter, open, single-arm Phase I clinical study. The safety, tolerance and PK characteristics of FCN-098 in patients with advanced solid tumors were determined, the MTD of oral FCN-098 was determined, and the RP2D of FCN-098 was determined, and the efficacy of FCN-098 was preliminarily evaluated.
- Conditions
- Solid Tumor
- Being tested
- FCN-098
- Keywords
- Solid Tumor, NTRK
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FCN-098Drug
FCN-098 will be given orally in ascending doses starting at 40 mg Q12h until the maximum tolerated dose or recommended dose is reached.
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation and Expansion | Experimental | FCN-098 will be given orally in ascending doses in patients with advanced solid tumor , until the maximum tolerated dose or recommended dose is reached. Receives: Drug: FCN-098 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of dose-limiting toxicity within 2 days of single administration and 28 days of continuous administration.
Measured: From first dose up to 28 days
Determine the recommended phase II dose
Measured: From first dose up to 28 days
Secondary outcomes (5)
To quantify the occurrence of adverse events (AEs) reported in all subjects who received study drug
Incidence of untoward medical occurrences (adverse event = AE) in a participant who received study drug. Adverse events will be evaluated by dosing cohort and recorded according to NCI CTCAEv5 Common Toxicity Criteria.
Measured: From enrollment up to 30 days after last dose
To quantify the occurrence of TESAE during the treatment and cause permanent withdrawal of toxic effects
Measured: From enrollment up to 30 days after last dose
the death of the last medicine occurred within 30 days of frequency and cause of death
Measured: From enrollment up to 30 days after last dose
To quantify the Plasma Concentration of FCN-098 and its metabolite M1 (FCN-097)
Measured: 2 months
To determine the best overall response rate (ORR) by Response Criteria in Solid Tumors (RECIST) v1.1 in subjects with advanced solid tumors
To evaluate the proportion of patients with an objective response (SD, PR, CR) as defined by RECIST 1.1.
Measured: Baseline up to approximately 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2022
- Study start31 Dec 2021
- Primary completion8 May 2024 (estimated)
- Study completion12 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies 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
- Sequential
- Model description
- Open-Label Phase 1 Dose escalation study
- Masking
- None (open label)
- Enrolment
- 43 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fochon Pharmaceuticals, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hu Xi chun, MD, Study director, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05212987
- Sponsor's protocol ID
- FCN-098-001
- Status last verified
- Dec 2021
- First submitted
- 28 Dec 2021
- Last updated
- 28 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Open, Single-arm Phase I Dose Exploratory Study to Evaluate the Safety, Tolerability, Pharmacokinetic Properties and Primary Antitumor Activity of FCN-098 in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05212987
- Acronym / sponsor ID
- FCN-098-001
- Conditions
- Solid Tumor
- Keywords
- Solid Tumor, NTRK
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- Fochon Pharmaceuticals, Ltd.Industry (pharma, biotech, devices)
- Study start
- 31 Dec 2021 (actual)
- Primary completion
- 8 May 2024 (estimated)
- Study completion
- 12 Oct 2024 (estimated)
- First posted
- 28 Jan 2022 (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.
A multi-center, open, single-arm phase I dose exploratory study to evaluate the safety, tolerability, pharmacokinetic characteristics and primary antitumor activity of FCN-098 in patients with advanced solid tumors.
Detailed description
This study is a multicenter, open, single-arm Phase I clinical study. The safety, tolerance and PK characteristics of FCN-098 in patients with advanced solid tumors were determined, the MTD of oral FCN-098 was determined, and the RP2D of FCN-098 was determined, and the efficacy of FCN-098 was preliminarily evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open-Label Phase 1 Dose escalation study
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation and Expansion | Experimental | Drug: FCN-098FCN-098 will be given orally in ascending doses in patients with advanced solid tumor , until the maximum tolerated dose or recommended dose is reached. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 1. Age ≥ 18 years，no gender limitation；
- 2. Patients with inoperable solid tumors, stage III or IV, confirmed histologically or cytologically by standard treatment failure or no standard treatment;
- 3. Dose-escalation stage: patients with advanced solid malignancies after failure of standard treatment (patients with positive NTRK gene fusion or mutations in the TRK kinase region are preferred); Dose expansion stage: patients with advanced solid malignant tumors with NTRK gene fusion positive or TRK kinase region mutation after standard treatment failure; NTRK gene fusion positive or TRK kinase region mutation can be included based on the positive report of the local laboratory, but tissues must be provided to the central laboratory for confirmation;
- 4. The ECOG Scores 0 or 1 for physical fitness (Dose-escalation stage),0-2(Dose expansion stage);
- 5. Can understand and be willing to sign informed consent prior to the commencement of any research procedure;
Key exclusion criteria (16 listed)
- 1. Patients who received targeted therapy or tyrosine kinase inhibitor therapy within 2 weeks or within 5 half-lives (whichever is shorter) before starting administration, and who received chemotherapy, major surgery, radiotherapy, Anti-tumor biopharmaceutical treatment, immunotherapy or clinical trials within 4 weeks or within 5 half-lives (which is shorter);
- 2. Uncontrolled or symptomatic brain metastases (asymptomatic or stably controlled CNS metastases and no hormone therapy within 2 weeks are allowed to be enrolled);Patients with spinal cord metastasis with symptoms of spinal cord compression;Primary CNS tumors were allowed to be enrolled.
- 3. The toxicity of previous anti-tumor therapy has not recovered (>NCI-CITCAE 5.0 level 2), neurotoxic reaction level 2, except hair loss;
- 4. Patients should use strong CYP3A4 inhibitors (except drugs permitted in Section 6.8), inducers or sensitive substrates and sensitive substrates of CYP2B6, CYP2C8, CYP2C6 at the same time;
- 5. Patients take drugs (mainly Ia, Ic, class III anti-arrhythmia drugs) that will prolong the QTc interval or have risk factors for extending the QTc interval;
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 |
|---|---|---|
| FCN-098FCN-098 will be given orally in ascending doses starting at 40 mg Q12h until the maximum tolerated dose or recommended dose is reached. | Drug | Dose Escalation and Expansion |
Primary outcome
Incidence of dose-limiting toxicity within 2 days of single administration and 28 days of continuous administration.
Time frame: From first dose up to 28 days
Determine the recommended phase II dose
Time frame: From first dose up to 28 days
5 secondary outcomes
To quantify the occurrence of adverse events (AEs) reported in all subjects who received study drug
Time frame: From enrollment up to 30 days after last dose
To quantify the occurrence of TESAE during the treatment and cause permanent withdrawal of toxic effects
Time frame: From enrollment up to 30 days after last dose
the death of the last medicine occurred within 30 days of frequency and cause of death
Time frame: From enrollment up to 30 days after last dose
To quantify the Plasma Concentration of FCN-098 and its metabolite M1 (FCN-097)
Time frame: 2 months
To determine the best overall response rate (ORR) by Response Criteria in Solid Tumors (RECIST) v1.1 in subjects with advanced solid tumors
Time frame: Baseline up to approximately 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2022.
- 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.
Hu Xi chun, MD study director
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing FCN-098 in people with Solid Tumor, run by Fochon Pharmaceuticals, Ltd. at 1 site in China.
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 9 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: status not confirmed, as of the sponsor's last update on 28 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hu Xi chun, MD (13816110335, xchu@2009hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of dose-limiting toxicity within 2 days of single administration and 28 days of continuous administration. (time frame: From first dose up to 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?
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 28 Jan 2022.