Non-Small Cell Lung CancerPhase 18479217NCT06469138
A Study to Investigate 14C-bemcentinib in Healthy Male Subjects
A Phase 1 study testing Bemcentinib in people with Non-Small Cell Lung Cancer and Metastatic Melanoma, run by BerGenBio ASA at 1 site in United Kingdom.
Trial summary
The aims of this Study were to determine: How much of the Study Drug (bemcentinib) ends up in urine and faeces How much of the Study Drug and its breakdown products get into the bloodstream The breakdown products (metabolites) of the Study Drug The safety of the Study Drug and any side effects that might be associated… Read more about this study
- Who is it for?
- Ages 35 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Non-Small Cell Lung Cancer, Metastatic Melanoma, Acute Myeloid Leukemia
- What is being tested?
- Bemcentinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Aug 2022to 23 Sep 2022
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 35 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males of any race, between 35 and 55 years of age, inclusive.
- Body mass index between 18.0 and 32.0 kg/m2, inclusive, and a total body weight between 50 and 100 kg, inclusive.
- In good health, determined by no clinically significant findings from medical history, vital signs measurements, and clinical laboratory evaluations (congenital nonhemolytic hyperbilirubinemia [eg, suspicion of Gilbert's syndrome based on total and direct bilirubin] is not acceptable) at screening and check-in and from the physical examination at check-in, as assessed by the investigator (or designee).
- No clinically significant abnormalities in 12-lead ECG determined within 28 days before dose of IMP including average PR > 220 ms and QT interval corrected for heart rate using Fridericia's formula >450 ms.
- No history of clinically significant dysrhythmias (long QT features on ECG, sustained bradycardia, left bundle branch block, or ventricular arrhythmia), atrial fibrillation, or history of familial long QT syndromes.
- Will agree to use contraception as detailed in the study protocol.
- Able to comprehend and willing to sign an ICF and to abide by the study restrictions.
- History of a minimum of 1 bowel movement per day.
Who cannot join
- Medical conditions
- Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator (or designee).
- History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator (or designee).
- History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair will be allowed).
- Positive hepatitis panel and/or positive human immunodeficiency virus test.
- Prior/concomitant therapy
Show all 28Show fewer
- Administration of a COVID-19 vaccine in the past 30 days prior to dosing.
- Use or intend to use any medications/products known to alter drug absorption, metabolism, or elimination processes, including St. John's wort, within 30 days prior to check-in, unless deemed acceptable by the investigator (or designee).
- Use or intend to use any prescription medications/products within 14 days prior to check-in, unless deemed acceptable by the investigator (or designee).
- Use or intend to use slow-release medications/products considered to still be active within 14 days prior to check-in, unless deemed acceptable by the investigator (or designee).
- Use or intend to use any nonprescription medications/products including vitamins, minerals, and phytotherapeutic/herbal/plant-derived preparations within 7 days prior to check-in, unless deemed acceptable by the investigator (or designee).
- Prior/concurrent clinical study experience
- Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 90 days prior to dosing.
- Subjects who have participated in any clinical study involving a radiolabelled investigational product within 12 months prior to check-in.
- Have previously completed or withdrawn from this study or any other study investigating bemcentinib, and have previously received bemcentinib.
- Diet and lifestyle
- Alcohol consumption of > 28 units per week for males. One unit of alcohol equals ½ pint (285 mL) of beer or lager, 1 glass (125 mL) of wine, or 1/6 gill (25 mL) of spirits.
- Positive alcohol breath test result or positive urine drug screen (confirmed by repeat) at screening or check-in.
- History of alcoholism or drug/chemical abuse within 2 years prior to check-in.
- Use of tobacco- or nicotine-containing products within 3 months prior to check-in, or positive cotinine at screening or check-in.
- Ingestion of poppy seed-, Seville orange-, or grapefruit-containing foods or beverages within 7 days prior to check-in.
- Other exclusions
- Receipt of blood products within 2 months prior to check-in.
- Donation of blood from 3 months prior to screening, plasma from 2 weeks prior to screening, or platelets from 6 weeks prior to screening.
- Poor peripheral venous access.
- Subjects with exposure to significant diagnostic or therapeutic radiation (eg, serial X-ray, computed tomography scan, barium meal) or current employment in a job requiring radiation exposure monitoring within 12 months prior to check-in.
- Subjects who, in the opinion of the investigator (or designee), should not participate in this study.
- Subjects may previously have been screened on a generic basis to determine their eligibility for inclusion in Phase 1 clinical studies conducted at the study site. If generic screening was performed within the specified study screening window, selected study-specific procedures will be repeated either at an additional screening visit or on admission to the study site on Day -1.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Labcorp Clinical Research Unit Ltd.
Leeds, LS2 9LH
About this study
Official title: A Phase 1, Open-label, Nonrandomized Study to Investigate the Mass Balance Recovery and Metabolic Profile of 14C-bemcentinib Following Single Oral Administration in Healthy Male Subjects
The aims of this Study were to determine:
- How much of the Study Drug (bemcentinib) ends up in urine and faeces
- How much of the Study Drug and its breakdown products get into the bloodstream
- The breakdown products (metabolites) of the Study Drug
- The safety of the Study Drug and any side effects that might be associated with it.
Read the detailed description
This was a Phase 1, open-label, nonrandomized, single oral dose study in up to 8 healthy male subjects (with 6 required to complete the study).
Potential subjects were screened to assess their eligibility to enter the study within 28 days prior to dose administration. Up to 8 subjects were enrolled to ensure that 6 subjects completed the study. Subjects were admitted into the study site on Day -1. On the morning of Day 1, all subjects received a single oral dose of 200 mg containing approximately 32.8 μCi (1.21 MBq) of 14C-bemcentinib, 30 minutes after starting a standard high-fat breakfast.
Subjects were confined to the study site until at least Day 8. Subjects were discharged from the study site on Day 8 if the following discharge criteria were met:
·≥90% mass balance recovery, and
·<1% of the total radioactive dose is recovered in combined excreta (urine and feces)in 2 consecutive 24-hour periods.
If these discharge criteria were not met by Day 8, subjects were required to remain resident until discharge criteria are met, up to Day 15. If criteria were not met by Day 15, subjects were asked to collect 24-hour excreta samples on up to 2 further occasions on a nonresidential basis to allow extrapolation of urinary and fecal excretion. If needed, the 2 additional 24-hour nonresidential collections started on the morning of Days 22 and 29 (to be brought into the study site at the end of the collection interval on Days 23 and 30, respectively). If on the second occasion the subject still did not meet the desired criterion, then the subject was discharged from the study, per investigator and sponsor decision.
Subjects experiencing emesis during the first 4 hours post-dose were discharged on the same day from the study site, provided there were no safety concerns, and after discharge study procedures were performed.
The total duration of study participation for each subject (from screening to outpatient visit [if required]) was anticipated to be a maximum of approximately 58 days.
- Conditions
- Non-Small Cell Lung Cancer, Metastatic Melanoma, Acute Myeloid Leukemia, Myelodysplastic Syndromes, Metastatic Pancreatic Cancer, Glioblastoma
- Being tested
- Bemcentinib
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Melanoma, Leukemia, Myeloid, Acute, Myelodysplastic Syndromes, Pancreatic Neoplasms, Glioblastoma, Mesothelioma, Malignant, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BemcentinibDrug
Also called BGB324
Each 200 mg dose contains approximately 32.8 μCi (1.21 MBq) of 14C-bemcentinib and is administered as a single dose on Day 1 of the study.
| Study group | Role | What they receive |
|---|---|---|
| Single Dose Cohort - 200 mg containing approximately 32.8 μCi (1.21 MBq) of 14C-bemcentinib | Experimental | This is the only treatment arm in this study. Up to 8 participants will receive a single oral dose of 200 mg containing approximately 32.8 μCi (1.21 MBq) of 14C-bemcentinib, 30 minutes after starting a standard high-fat breakfast. Receives: Drug: Bemcentinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Radioactivity - Plasma Maximum Observed Concentration (Cmax)
This endpoint will report the relevant data for the parameters assessed in order to measure total radioactivity in plasma (based upon plasma samples collected at set timepoints during the study). Analysis was derived from obtaining plasma samples from participants at set timepoints described and deriving PK parameters through the use of noncompartmental procedures in validated software (WinNonlin Version 8.3.5).
Measured: Samples collected over a 2-week period: Days 1-8: Predose, 15 and 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours post-dose, Days 8-15: 192, 216, 240, 264, 288, 312, and 336 hours post-dose
Total Radioactivity - Whole Blood Maximum Observed Concentration (Cmax)
This endpoint will report the relevant data for the parameters assessed in order to measure total radioactivity in whole blood (based upon whole blood samples collected at set timepoints during the study). Analysis was derived from obtaining whole blood samples from participants at set timepoints described and deriving PK parameters through the use of noncompartmental procedures in validated software (WinNonlin Version 8.3.5).
Measured: Samples collected over a 2-week period: Days 1-8: Predose, 15 and 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours post-dose, Days 8-15: 192, 216, 240, 264, 288, 312, and 336 hours post-dose
Plasma Pharmacokinetic Parameters Bemcentinib - Maximum Observed Concentration (Cmax)
Plasma samples will be obtained in order to evaluate defined plasma pharmacokinetic parameters for 14C-bemcentinib. This endpoint will report the summary of derived pharmacokinetic parameters for the maximum observed concentration (Cmax) of 14C-bemcentinib in plasma. Analysis was derived from obtaining plasma samples from participants at set timepoints described and deriving PK parameters through the use of noncompartmental procedures in validated software (WinNonlin Version 8.3.5).
Measured: Samples collected over a 2-week period: Days 1-8: Predose, 15 and 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours post-dose, Days 8-15: 192, 216, 240, 264, 288, 312, and 336 hours post-dose
Plasma Pharmacokinetic Parameters Bemcentinib - Time to Maximum Observed Concentration (Tmax)
Plasma samples will be obtained in order to evaluate defined plasma pharmacokinetic parameters for 14C-bemcentinib. This endpoint will report the summary of derived pharmacokinetic parameters for the time to maximum observed concentration (Tmax) of 14C-bemcentinib in plasma. Analysis was derived from obtaining plasma samples from participants at set timepoints described and deriving PK parameters through the use of noncompartmental procedures in validated software (WinNonlin Version 8.3.5).
Measured: Samples collected over a 2-week period: Days 1-8: Predose, 15 and 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours post-dose, Days 8-15: 192, 216, 240, 264, 288, 312, and 336 hours post-dose
Plasma Pharmacokinetic Parameters Bemcentinib - Terminal Elimination Half-life (t1/2)
Plasma samples will be obtained in order to evaluate defined plasma pharmacokinetic parameters for 14C-bemcentinib. This endpoint will report the summary of derived pharmacokinetic parameters for the terminal elimination half-life (t1/2) of 14C-bemcentinib in plasma. Analysis was derived from obtaining plasma samples from participants at set timepoints described and deriving PK parameters through the use of noncompartmental procedures in validated software (WinNonlin Version 8.3.5).
Measured: Samples collected over a 2-week period: Days 1-8: Predose, 15 and 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours post-dose, Days 8-15: 192, 216, 240, 264, 288, 312, and 336 hours post-dose
Plasma Pharmacokinetic Parameters Bemcentinib - Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-∞)
Plasma samples will be obtained in order to evaluate defined plasma pharmacokinetic parameters for 14C-bemcentinib. This endpoint will report the summary of derived pharmacokinetic parameters for the area under the concentration-time curve from time 0 extrapolated to infinity (AUC0-∞) of 14C-bemcentinib in plasma. Analysis was derived from obtaining plasma samples from participants at set timepoints described and deriving PK parameters through the use of noncompartmental procedures in validated software (WinNonlin Version 8.3.5).
Measured: Samples collected over a 2-week period: Days 1-8: Predose, 15 and 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours post-dose, Days 8-15: 192, 216, 240, 264, 288, 312, and 336 hours post-dose
Plasma Pharmacokinetic Parameters Bemcentinib - Area Under the Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-tlast)
Plasma samples will be obtained in order to evaluate defined plasma pharmacokinetic parameters for 14C-bemcentinib. This endpoint will report the summary of derived pharmacokinetic parameters for the area under the concentration-time curve from time 0 to the time of the last quantifiable concentration (AUC0-tlast) of 14C-bemcentinib in plasma. Analysis was derived from obtaining plasma samples from participants at set timepoints described and deriving PK parameters through the use of noncompartmental procedures in validated software (WinNonlin Version 8.3.5).
Measured: Samples collected over a 2-week period: Days 1-8: Predose, 15 and 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours post-dose, Days 8-15: 192, 216, 240, 264, 288, 312, and 336 hours post-dose
Secondary outcomes (5)
Number of Participants With Adverse Events
This secondary endpoint relates to the number of participants who report an adverse event (AE) during the study.
Measured: Collection of AEs occurs through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 5 weeks).
Number of Participants Who Report a Change From Normal Range Values for Laboratory Safety Parameters (Serum Biochemistry, Serum Haematology or Urinalysis) From First Dose on Day 1 to Study Completion.
This secondary endpoint will report the number of participants who record a value which is deemed as outside of the normal range (clinically significant values only) for any of the serum biochemistry, serum haematology or urinalysis parameters as defined in the study protocol following first dose administration on Day 1 up to completion of the study.
Measured: From Day 1 to study completion (up to 5 weeks)
Number of Participants Who Report a Change From Normal Range Values for Any of the Associated 12-Lead ECG Parameters From First Dose on Day 1 to Study Completion.
This secondary endpoint will report the number of participants who record a value which is deemed as outside of the normal range (clinically significant values only) for any of the 12-Lead ECG parameters as defined in the study protocol following first dose administration on Day 1 up to completion of the study.
Measured: From Day 1 to study completion (up to 5 weeks)
Number of Participants Who Report a Change From Normal Range Values for Any of the Vital Signs Parameters From First Dose on Day 1 to Study Completion.
This secondary endpoint will report the number of participants who record a value which is deemed as outside of the normal range (clinically significant values only) for any of the vital signs parameters as defined in the study protocol following first dose administration on Day 1 up to completion of the study.
Measured: From Day 1 to study completion (up to 5 weeks)
Number of Participants Who Report a Change From Normal With Respect to Physical Examination Parameters From First Dose on Day 1 to Study Completion.
This secondary endpoint will report the number of participants who record a change which is deemed as outside of normal range (clinically significant changes only) for any of the physical examination parameters as defined in the study protocol following first dose administration on Day 1 up to completion of the study.
Measured: From Day 1 to study completion (up to 5 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2024
- Study start2 Aug 2022
- Primary completion23 Sep 2022
- Study completion23 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Non-Small Cell Lung 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
- Model description
- All participants will be assigned to active treatment and will be dosed within a single cohort of up to 8 participants (with 6 required to complete).
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- BerGenBio ASA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr Brooks, MBChB, Principal investigator, Labcorp Clinical Research Unit Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06469138
- Sponsor's protocol ID
- BGBC021
- Acronym
- 8479217
- Status last verified
- Dec 2024
- First submitted
- 17 Jun 2024
- Last updated
- 29 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: At this stage, it is not planned that any IPD information will be shared with other researchers outside of the Sponsor and Clinical Research Organisation undertaking the conduct of this study.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Nonrandomized Study to Investigate the Mass Balance Recovery and Metabolic Profile of 14C-bemcentinib Following Single Oral Administration in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT06469138
- Acronym / sponsor ID
- 8479217 / BGBC021
- Conditions
- Non-Small Cell Lung Cancer, Metastatic Melanoma, Acute Myeloid Leukemia, Myelodysplastic Syndromes, Metastatic Pancreatic Cancer, Glioblastoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- BerGenBio ASAIndustry (pharma, biotech, devices)
- Study start
- 2 Aug 2022 (actual)
- Primary completion
- 23 Sep 2022 (actual)
- Study completion
- 23 Sep 2022 (actual)
- First posted
- 21 Jun 2024 (actual)
- Results
- Posted 29 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aims of this Study were to determine:
- How much of the Study Drug (bemcentinib) ends up in urine and faeces
- How much of the Study Drug and its breakdown products get into the bloodstream
- The breakdown products (metabolites) of the Study Drug
- The safety of the Study Drug and any side effects that might be associated with it.
Detailed description
This was a Phase 1, open-label, nonrandomized, single oral dose study in up to 8 healthy male subjects (with 6 required to complete the study).
Potential subjects were screened to assess their eligibility to enter the study within 28 days prior to dose administration. Up to 8 subjects were enrolled to ensure that 6 subjects completed the study. Subjects were admitted into the study site on Day -1. On the morning of Day 1, all subjects received a single oral dose of 200 mg containing approximately 32.8 μCi (1.21 MBq) of 14C-bemcentinib, 30 minutes after starting a standard high-fat breakfast.
Subjects were confined to the study site until at least Day 8. Subjects were discharged from the study site on Day 8 if the following discharge criteria were met:
·≥90% mass balance recovery, and
·<1% of the total radioactive dose is recovered in combined excreta (urine and feces)in 2 consecutive 24-hour periods.
If these discharge criteria were not met by Day 8, subjects were required to remain resident until discharge criteria are met, up to Day 15. If criteria were not met by Day 15, subjects were asked to collect 24-hour excreta samples on up to 2 further occasions on a nonresidential basis to allow extrapolation of urinary and fecal excretion. If needed, the 2 additional 24-hour nonresidential collections started on the morning of Days 22 and 29 (to be brought into the study site at the end of the collection interval on Days 23 and 30, respectively). If on the second occasion the subject still did not meet the desired criterion, then the subject was discharged from the study, per investigator and sponsor decision.
Subjects experiencing emesis during the first 4 hours post-dose were discharged on the same day from the study site, provided there were no safety concerns, and after discharge study procedures were performed.
The total duration of study participation for each subject (from screening to outpatient visit [if required]) was anticipated to be a maximum of approximately 58 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will be assigned to active treatment and will be dosed within a single cohort of up to 8 participants (with 6 required to complete).
| Arm | Type | Receives |
|---|---|---|
| Single Dose Cohort - 200 mg containing approximately 32.8 μCi (1.21 MBq) of 14C-bemcentinib | Experimental | Drug: BemcentinibThis is the only treatment arm in this study. Up to 8 participants will receive a single oral dose of 200 mg containing approximately 32.8 μCi (1.21 MBq) of 14C-bemcentinib, 30 minutes after starting a standard high-fat breakfast. |
Who may qualify
- Ages
- 35 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Males of any race, between 35 and 55 years of age, inclusive.
- Body mass index between 18.0 and 32.0 kg/m2, inclusive, and a total body weight between 50 and 100 kg, inclusive.
- In good health, determined by no clinically significant findings from medical history, vital signs measurements, and clinical laboratory evaluations (congenital nonhemolytic hyperbilirubinemia [eg, suspicion of Gilbert's syndrome based on total and direct bilirubin] is not acceptable) at screening and check-in and from the physical examination at check-in, as assessed by the investigator (or designee).
- No clinically significant abnormalities in 12-lead ECG determined within 28 days before dose of IMP including average PR > 220 ms and QT interval corrected for heart rate using Fridericia's formula >450 ms.
- No history of clinically significant dysrhythmias (long QT features on ECG, sustained bradycardia, left bundle branch block, or ventricular arrhythmia), atrial fibrillation, or history of familial long QT syndromes.
Key exclusion criteria (28 listed)
- Medical conditions
- Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator (or designee).
- History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator (or designee).
- History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair will be allowed).
- Positive hepatitis panel and/or positive human immunodeficiency virus test.
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 |
|---|---|---|
| BemcentinibAlso: BGB324Each 200 mg dose contains approximately 32.8 μCi (1.21 MBq) of 14C-bemcentinib and is administered as a single dose on Day 1 of the study. | Drug | Single Dose Cohort - 200 mg containing approximately 32.8 μCi (1.21 MBq) of 14C-bemcentinib |
Primary outcome
Total Radioactivity - Plasma Maximum Observed Concentration (Cmax)
Time frame: Samples collected over a 2-week period: Days 1-8: Predose, 15 and 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours post-dose, Days 8-15: 192, 216, 240, 264, 288, 312, and 336 hours post-dose
This endpoint will report the relevant data for the parameters assessed in order to measure total radioactivity in plasma (based upon plasma samples collected at set timepoints during the study). Analysis was derived from obtaining plasma samples from participants at set timepoints described and deriving PK parameters through the use of noncompartmental procedures in validated software (WinNonlin Version 8.3.5).
Total Radioactivity - Whole Blood Maximum Observed Concentration (Cmax)
Time frame: Samples collected over a 2-week period: Days 1-8: Predose, 15 and 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours post-dose, Days 8-15: 192, 216, 240, 264, 288, 312, and 336 hours post-dose
This endpoint will report the relevant data for the parameters assessed in order to measure total radioactivity in whole blood (based upon whole blood samples collected at set timepoints during the study). Analysis was derived from obtaining whole blood samples from participants at set timepoints described and deriving PK parameters through the use of noncompartmental procedures in validated software (WinNonlin Version 8.3.5).
Plasma Pharmacokinetic Parameters Bemcentinib - Maximum Observed Concentration (Cmax)
Time frame: Samples collected over a 2-week period: Days 1-8: Predose, 15 and 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours post-dose, Days 8-15: 192, 216, 240, 264, 288, 312, and 336 hours post-dose
Plasma samples will be obtained in order to evaluate defined plasma pharmacokinetic parameters for 14C-bemcentinib. This endpoint will report the summary of derived pharmacokinetic parameters for the maximum observed concentration (Cmax) of 14C-bemcentinib in plasma. Analysis was derived from obtaining plasma samples from participants at set timepoints described and deriving PK parameters through the use of noncompartmental procedures in validated software (WinNonlin Version 8.3.5).
Plasma Pharmacokinetic Parameters Bemcentinib - Time to Maximum Observed Concentration (Tmax)
Time frame: Samples collected over a 2-week period: Days 1-8: Predose, 15 and 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours post-dose, Days 8-15: 192, 216, 240, 264, 288, 312, and 336 hours post-dose
Plasma samples will be obtained in order to evaluate defined plasma pharmacokinetic parameters for 14C-bemcentinib. This endpoint will report the summary of derived pharmacokinetic parameters for the time to maximum observed concentration (Tmax) of 14C-bemcentinib in plasma. Analysis was derived from obtaining plasma samples from participants at set timepoints described and deriving PK parameters through the use of noncompartmental procedures in validated software (WinNonlin Version 8.3.5).
Plasma Pharmacokinetic Parameters Bemcentinib - Terminal Elimination Half-life (t1/2)
Time frame: Samples collected over a 2-week period: Days 1-8: Predose, 15 and 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours post-dose, Days 8-15: 192, 216, 240, 264, 288, 312, and 336 hours post-dose
Plasma samples will be obtained in order to evaluate defined plasma pharmacokinetic parameters for 14C-bemcentinib. This endpoint will report the summary of derived pharmacokinetic parameters for the terminal elimination half-life (t1/2) of 14C-bemcentinib in plasma. Analysis was derived from obtaining plasma samples from participants at set timepoints described and deriving PK parameters through the use of noncompartmental procedures in validated software (WinNonlin Version 8.3.5).
Plasma Pharmacokinetic Parameters Bemcentinib - Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-∞)
Time frame: Samples collected over a 2-week period: Days 1-8: Predose, 15 and 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours post-dose, Days 8-15: 192, 216, 240, 264, 288, 312, and 336 hours post-dose
Plasma samples will be obtained in order to evaluate defined plasma pharmacokinetic parameters for 14C-bemcentinib. This endpoint will report the summary of derived pharmacokinetic parameters for the area under the concentration-time curve from time 0 extrapolated to infinity (AUC0-∞) of 14C-bemcentinib in plasma. Analysis was derived from obtaining plasma samples from participants at set timepoints described and deriving PK parameters through the use of noncompartmental procedures in validated software (WinNonlin Version 8.3.5).
Plasma Pharmacokinetic Parameters Bemcentinib - Area Under the Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-tlast)
Time frame: Samples collected over a 2-week period: Days 1-8: Predose, 15 and 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours post-dose, Days 8-15: 192, 216, 240, 264, 288, 312, and 336 hours post-dose
Plasma samples will be obtained in order to evaluate defined plasma pharmacokinetic parameters for 14C-bemcentinib. This endpoint will report the summary of derived pharmacokinetic parameters for the area under the concentration-time curve from time 0 to the time of the last quantifiable concentration (AUC0-tlast) of 14C-bemcentinib in plasma. Analysis was derived from obtaining plasma samples from participants at set timepoints described and deriving PK parameters through the use of noncompartmental procedures in validated software (WinNonlin Version 8.3.5).
5 secondary outcomes
Number of Participants With Adverse Events
Time frame: Collection of AEs occurs through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 5 weeks).
Number of Participants Who Report a Change From Normal Range Values for Laboratory Safety Parameters (Serum Biochemistry, Serum Haematology or Urinalysis) From First Dose on Day 1 to Study Completion.
Time frame: From Day 1 to study completion (up to 5 weeks)
Number of Participants Who Report a Change From Normal Range Values for Any of the Associated 12-Lead ECG Parameters From First Dose on Day 1 to Study Completion.
Time frame: From Day 1 to study completion (up to 5 weeks)
Number of Participants Who Report a Change From Normal Range Values for Any of the Vital Signs Parameters From First Dose on Day 1 to Study Completion.
Time frame: From Day 1 to study completion (up to 5 weeks)
Number of Participants Who Report a Change From Normal With Respect to Physical Examination Parameters From First Dose on Day 1 to Study Completion.
Time frame: From Day 1 to study completion (up to 5 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. At this stage, it is not planned that any IPD information will be shared with other researchers outside of the Sponsor and Clinical Research Organisation undertaking the conduct of this study.
Related trials for Non-Small Cell Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
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.
Dr Brooks, MBChB principal investigator
Labcorp Clinical Research Unit Ltd.
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 Bemcentinib in people with Non-Small Cell Lung Cancer and Metastatic Melanoma, run by BerGenBio ASA at 1 site in United Kingdom.
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 8 inclusion and 28 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 Jan 2025. 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 United Kingdom. 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?
Yes. Results are posted in the registry (first posted 29 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Total Radioactivity - Plasma Maximum Observed Concentration (Cmax) (time frame: Samples collected over a 2-week period: Days 1-8: Predose, 15 and 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours post-dose, Days 8-15: 192, 216, 240, 264, 288, 312, and 336 hours post-dose). The study lists 7 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 29 Jan 2025; AzTrials last refreshed its copy on 8 Nov 2026.