A Phase 1 interventional study of FCN-437 in Solid Tumor, Adult, sponsored by Fochon Pharmaceuticals, Ltd.. Completed at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-16.
Sponsored by Fochon Pharmaceuticals, Ltd. · Phase 1, Interventional, and Treatment
This research study is studying a drug called FCN-437c as a possible treatment for patients with advanced unresectable/metastatic solid tumors.
This research study is a Phase I clinical trial, which tests the safety of an investigational intervention and also tries to define the appropriate dose of the investigational intervention to use for further studies. "Investigational" means that the intervention is being studied.
In this research study, the investigators are evaluating a new drug, FCN-437c, as a potential new treatment for cancer.
The FDA (the U.S. Food and Drug Administration) has not approved FCN-437c as a treatment for any disease.
FCN-437c is a new generation CDK4/6 inhibitor. The CDK 4/6 inhibitors play a key role in regulating the transition from G1 to the S-phase of the cell cycle.
The cyclin D-cyclin dependent kinase (CDK) 4/6-inhibitor of CDK4 (INK4)-retinoblastoma (Rb) pathway controls cell cycle progression by regulating the G1-S checkpoint. Dysregulation of the cyclin D-CDK4/6-INK4-Rb pathway results in increased proliferation, and is frequently observed in many types of cancer. Due to the importance of CDK4/6 activity in cancer cells, CDK4/6 inhibitors have emerged as promising candidates for cancer treatment.
FCN-437c is a novel, potent and selective inhibitor of CDK4/6 exhibiting cellular potency against a number of human tumor cell lines.
Laboratory experiments show that FNC-437c may stop tumor growth.
The purposes of this study are:
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's enrollment of 22 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Fochon Pharmaceuticals, Ltd. is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Histologically/cytologically confirmed, unresectable locally advanced or metastatic solid tumors that are refractory to standard therapy or for which no standard therapy exists. Note for patients with non-small cell lung cancer [NSCLC] and patients with activating ALK translocation, or EFGR mutations must have been treated and failed appropriate targeted treatment).
Subjects enrolled in cohort expansion at MTD should have specific tumor types as below:
All subjects should have evaluable disease as per RECIST 1.1 (Eisenhauer, 2009).
Subjects enrolled in cohort expansion at MTD should have measurable disease (presence of at least one measurable lesion) as per RECIST 1.1.
Must have adequate organ function, including the following:
Exclusion Criteria:
The dose-escalation cohort: * Participants will receive FCN-437c monotherapy once daily (QD) for 21 days followed by a 7 day rest period (28-day cycle). * FCN-437c will be administered orally. * Participants with histologically or cytologically confirmed advanced unresectable/metastatic solid tumor will participate in this cohort.
Drug: FCN-437
FCN-437c is a selective and potent CDK4/6 dual inhibitor, with broad antitumor activity in preclinical pharmacology models, favorable physical and pharmacokinetic (PK) properties, and acceptable toxicity profile in nonclinical studies.
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.
Time frame: From enrollment up to 30 days after last dose
To determine the occurrence of treatment-emergent adverse events (TEAs)
Incidence of untoward medical occurrences (adverse event = AE) attributed to study drug in a participant who received study drug. Adverse events will be evaluated and recorded by dosing cohort according to NCI CTCAEv5 Common Toxicity Criteria.
Time frame: From first dose up to 30 days after last dose
To determine the occurrence of treatment-related adverse events meeting the criteria for dose limiting toxicities (DLTs)
Incidence of the DLT population will consist all subjects who received the required amount of study drug during the DLT observation period of 28 days (21 days of daily dosing, 7 days of no dosing) of study treatment . Treatment-related AE is any untoward medical occurrence attributed to study drug in a participant that who received study drug. Treatment-related AE is any untoward medical occurrence attributed to study drug in a participant who received study drug. DLTs are adverse events meeting the protocol-specified criteria, evaluated and recorded according to NCI CTCAEv5 Common Toxicity Criteria will use medical terminology based on the Medical Dictionary for Regulatory Activities Terminology (MedDRA).
Time frame: From first dose up to 28 days
To quantify the area under the serum concentration versus time curve (AUC) of FCN-437c after administration as a single agent
Quantify the dose-dependent area under the serum concentration versus time curve (AUC) for FCN-437c following single dosing FCN-437c
Time frame: 2 months
To quantify the last time point with a quantifiable concentration (AUClast) of FCN-437c after administration as a single agent
Determine the dose-dependent plasma concentrations of FCN-437c from the time of dosing to the last time point with a quantifiable concentration (AUClast) of FCN-437-c following single doses of FCN-437c as a single agent.
Time frame: 2 months
To quantify the plasma concentrations at the end of a dosing interval (Ctau) of FCN-437c after administration as a single agent
Determine the dose-dependent serum concentrations (Cmax) of FCN-437c as as a single agent at the end of a dosing interval (Ctau), where tau is 24 hours
Time frame: 2 months
To quantify the lowest plasma concentration at the end of a dosing interval (Ctrough)
Determine the dose-dependent lowest plasma concentrations (Ctrough) of FCN-437c as a single agent at the end of a dosing interval
Time frame: 2 months
To measure the time to reach the highest plasma concentrations (Tmax) of FCN-437c after single agent administration
Determine the dose-dependent time (Tmax) to reach the highest plasma concentrations of FCN-437c by direct inspection of the plasma concentration time curves of FCN-437c following single agent doses of FCN-437c
Time frame: 2 months
To quantify the terminal half-life (T1/2) of FCN-437c after administration as a single agent
Determine the dose-dependent terminal plasma half-life of FCN-437 (T 1/2) as single agent
Time frame: 2 months
To quantify the plasma clearance (CL/f) of FCN-437c after administration as a single agent
Determine the dose-dependent apparent total plasma clearance (CL/f) of FCN-437c after administration as a single agent
Time frame: 2 months
To evaluate the volume of distribution (Vf) of FCN-437c after administration as a single agent
Determine the apparent steady-state volume of distribution (Vf) during terminal phase after administration of FCN-437c as single agent
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
To evaluate the proportion of patients with an objective response (SD, PR, CR) as defined by RECIST 1.1.
Time frame: Baseline up to approximately 1 year
To correlate the degree of tumor-specific CDK4/6 inhibition to the dose level of FCN-437c
Determine the association between plasma levels of FCN-437C and the degree of tumor-specific CDK4/6 inhibition.
Time frame: Baseline up to approximately 1 year
To correlate the degree of dose-related tumor-specific CDK4/6 inhibition of FCN-437c and tumor response
Determine the association between FCN-437C antitumor activity and tumor-specific CDK4/6 inhibition
Time frame: Baseline up to approximately 1 year
To correlate the retinoblastoma (Rb) protein expression as a potential predictive biomarker to FCN-437c tumor response according to RECIST 1.1 criteria
To evaluate the proportion of patients expressing the retinoblastoma (Rb) protein with a reduction in tumor burden as defined by RECIST 1.1. criteria that may predict a response or resistance to FCN-437c treatment in solid tumors
Time frame: Baseline up to approximately 1 year
To correlate phosphorylated retinoblastoma (Rb) protein expression as a potential predictive biomarker for FCN-437c tumor response according to RECIST 1.1 criteria
To evaluate the proportion of patients expressing phosphorylated retinoblastoma (Rb) protein with a reduction in tumor burden as defined by RECIST 1.1. criteria that may predict a response or resistance to FCN-437c treatment in solid tumors
Time frame: Baseline up to approximately 1 year
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Fochon Pharmaceuticals, Ltd.