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EGFR Mutant Advanced Non-small Cell Lung CancerPhase 1NCT07620951

Material Balance of [14C]Zorifertinib in Healthy Adult Male Participants in China

A Phase 1 study testing [14C]Zorifertinib Oral Formulation in people with EGFR Mutant Advanced Non-small Cell Lung Cancer and Central Nervous System (CNS) Metastases, run by Alpha Biopharma (Jiangsu) Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a single-center, single-dose, open-label, Phase I study to evaluate the mass balance, biotransformation, pharmacokinetic characteristics, excretion pathways, and safety of a single oral 200 mg/5 µCi dose of [14C]Zorifertinib in healthy Chinese adult male participants. Read more about this study

Who is it for?
Ages 18 to 45 years, men onlyHealthy volunteers can take part
What is being tested?
[14C]Zorifertinib Oral Formulation
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 siteChina
Study dates
6 Jul 2026to 3 Aug 2026
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 to 45 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy Chinese males;
  • Age at the time of signing the informed consent form: 18-45 years (inclusive);
  • Body mass index (BMI) ranging from 19-26 kg/m2 (inclusive), with a body weight of no less than 50 kg;
  • Fully understand the purpose and requirements of this study and voluntarily sign the informed consent form;
  • Be able to communicate well with the investigators and complete the trial according to the protocol.
  • The 14C content in plasma and urine samples obtained during screening are within general environmental 14C background levels. Directly analyzed plasma samples must have values ≤150 pMC, and urine samples containing petroleum-based carbon carriers must have values ≤50 pMC.

Who cannot join

  • Ancillary Examinations:
  • Abnormal findings from comprehensive physical examination, vital signs, laboratory tests (hematology, blood biochemistry, coagulation function, urinalysis, routine stool + occult blood, thyroid function), 12-lead ECG, chest X-ray (posteroanterior view), abdominal ultrasound, digital rectal examination, etc., that are judged by the investigator as clinically significant.
  • Resting corrected QT interval (Fridericia correction, QTcF = QT/RR1/3) obtained from 12-lead ECG >450 ms in males, or other abnormalities judged by the investigator as clinically significant.
  • Positive result for any of the following: hepatitis B surface antigen or hepatitis B e antigen, hepatitis C virus antibody, Treponema pallidum antibody, or human immunodeficiency virus antigen/antibody combination test (HIV-Ag/Ab).
  • Abnormal findings from ophthalmic examination (slit lamp, intraocular pressure, fundus photography) that are clinically significant.
  • Medication History:
Show all 29Show fewer
  • Use of any drugs that inhibit or induce the drug-metabolizing enzyme CYP3A4 within 30 days prior to the screening period.
  • Use of any prescription drugs, over-the-counter drugs, herbal medicines, or food supplements (e.g., vitamins, calcium supplements) within 14 days prior to the screening period.
  • Medical and Surgical History:
  • History of any clinically serious disease or condition that the investigator believes may affect the trial results, including but not limited to circulatory, respiratory, endocrine, nervous, digestive, urinary, hematologic, immune, psychiatric, or metabolic diseases;
  • History of dysphagia or any condition that may affect drug absorption, e.g., gastrectomy, cholecystectomy, gastric bypass, duodenotomy, colectomy, inflammatory bowel disease;
  • History of organic heart disease, heart failure, myocardial infarction, angina pectoris, arrhythmia, ventricular tachycardia, clinically symptomatic AV block, long QT syndrome, or family history of long QT syndrome (evidenced by genetic proof or sudden cardiac death of a close relative at a young age);
  • Major surgery within 6 months prior to the screening period, or surgical incision not fully healed; Major surgery includes, but is not limited to, any procedure with significant bleeding risk, prolonged general anesthesia, incisional biopsy, or significant traumatic injury;
  • Allergic constitution, e.g., known history of allergy to two or more substances; Or judged by the investigator as potentially allergic to the investigational drug;
  • Hemorrhoids or perianal diseases with regular/ongoing hematochezia, irritable bowel syndrome, inflammatory bowel disease.
  • Lifestyle Habits:
  • Habitual constipation or diarrhea;
  • Alcoholism or regular alcohol consumption within 6 months prior to screening, i.e., alcohol intake exceeding 14 units per week (1 unit = 360 mL beer, or 45 mL spirit with 40% alcohol, or 150 mL wine), or a breath alcohol test result ≥20 mg/dL at screening, or inability to abstain from alcohol during the trial period;
  • Smoking >5 cigarettes per day or habitual use of nicotine-containing products within 3 months prior to screening, or inability to abstain during the trial period;
  • Drug abuse or use of soft drugs (e.g., cannabis) within 3 months prior to screening, or use of hard drugs (e.g., amphetamines, phencyclidine) within 1 year prior to screening; Or positive urine screen for drugs of abuse during the screening period;
  • Habitual consumption of grapefruit juice or excessive tea, coffee, and/or caffeinated beverages, and inability to abstain during the study period.
  • Others:
  • Participation in a radiolabeled drug trial within 1 year prior to screening, or participation in a 14C-labeled breath test within 3 months prior to screening;
  • History of needle phobia or blood phobia, difficulty with blood collection, or inability to tolerate venous puncture;
  • Participation in any other clinical trial (including drug and device trials) within 3 months prior to the screening period;
  • Vaccination within 1 month prior to screening, or planned vaccination during the study period;
  • Plan to father a child or donate sperm during the study period or within 1 year after study completion, or disagreement to use strict contraceptive measures (see Appendix 1) for themselves and their partners during the study period and within 1 year after study completion;
  • Blood loss or blood donation of ≥400 mL within 3 months prior to screening, or blood transfusion within 1 month;
  • Any other factor that, in the investigator's opinion, makes the participant unsuitable for participation in this trial.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215000

Other trials in China

About this study

Official title: Phase I Clinical Study on Material Balance of [14C]Zorifertinib in Healthy Adult Male Participants in China

This is a single-center, single-dose, open-label, Phase I study to evaluate the mass balance, biotransformation, pharmacokinetic characteristics, excretion pathways, and safety of a single oral 200 mg/5 µCi dose of [14C]Zorifertinib in healthy Chinese adult male participants. The study includes a screening period (Day -14 to Day -1) and a dosing and observation period (Day 1 to Day 14). Blood, urine, and feces samples will be collected to measure radioactivity, drug concentrations, and metabolites. Safety will be assessed by adverse events, vital signs, laboratory tests, 12-lead ECG, and ophthalmic examinations. The target total radioactivity recovery is ≥90% of the administered dose.

Being tested
[14C]Zorifertinib Oral Formulation
Medical subject headings
Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • [14C]Zorifertinib Oral FormulationDrug

    Single oral administration of 200 mg/5 µCi [¹⁴C]Zorifertinib in healthy male subjects under fasting condition

Study groups in NCT07620951
Study groupRoleWhat they receive
Single Dose Zorifertinib GroupExperimentalNot described
Receives: Drug: [14C]Zorifertinib Oral Formulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Total radioactive recovery and cumulative total radioactive recovery in urine and feces at each time interval

    Measured: Pre-dose up to 312 hours after dosing, or until termination criteria met

  2. Percentage of total radioactivity exposure (%AUC), percentage of parent drug and its metabolites (%Dose), and metabolite identification

    Percentage of total radioactivity exposure (%AUC) accounted for by parent drug and its metabolites in plasma. Percentage of administered dose (%Dose) accounted for by parent drug and its metabolites in urine and faeces. Identification of metabolites in plasma, urine, and feces

    Measured: Pre-dose up to 312 hours after dosing, or until termination criteria met

  3. Peak Plasma Concentration (Cmax)

    Pharmacokinetic parameters of total radioactivity in plasma and whole blood (if applicable)

    Measured: Pre-dose up to 120 hours after dosing,or until termination criteria met

  4. Time to Peak Concentration (Tmax)

    Pharmacokinetic parameters of total radioactivity in plasma and whole blood (if applicable)

    Measured: Pre-dose up to 120 hours after dosing,or until termination criteria met

  5. Area under the plasma concentration versus time curve (AUC)

    Pharmacokinetic parameters of total radioactivity in plasma and whole blood (if applicable)

    Measured: Pre-dose up to 120 hours after dosing,or until termination criteria met

  6. Elimination Half-Life (t1/2)

    Pharmacokinetic parameters of total radioactivity in plasma and whole blood (if applicable)

    Measured: Pre-dose up to 120 hours after dosing,or until termination criteria met

  7. Terminal Rate Constant (λz)

    Pharmacokinetic parameters of total radioactivity in plasma and whole blood (if applicable)

    Measured: Pre-dose up to 120 hours after dosing,or until termination criteria met

  8. Apparent Volume of Distribution (Vz/F)

    Pharmacokinetic parameters of total radioactivity in plasma and whole blood (if applicable)

    Measured: Pre-dose up to 120 hours after dosing,or until termination criteria met

  9. Apparent Clearance (CLz/F)

    Pharmacokinetic parameters of total radioactivity in plasma and whole blood (if applicable)

    Measured: Pre-dose up to 120 hours after dosing,or until termination criteria met

  10. Mean Residence Time (MRT)

    Pharmacokinetic parameters of total radioactivity in plasma and whole blood (if applicable)

    Measured: Pre-dose up to 120 hours after dosing,or until termination criteria met

  11. Whole blood / plasma total radioactivity ratio

    Measured: Pre-dose up to 120 hours after dosing,or until termination criteria met

Secondary outcomes (9)

  1. Peak Plasma Concentration (Cmax)

    Pharmacokinetic parameters for zorifertinib, its metabolite (AZ'1168), and other major metabolites (if applicable) in plasma

    Measured: Pre-dose up to 120 hours after dosing,or until termination criteria met

  2. Time to Peak Concentration (Tmax)

    Pharmacokinetic parameters for zorifertinib, its metabolite (AZ'1168), and other major metabolites (if applicable) in plasma

    Measured: Pre-dose up to 120 hours after dosing,or until termination criteria met

  3. Area under the plasma concentration versus time curve (AUC)

    Pharmacokinetic parameters for zorifertinib, its metabolite (AZ'1168), and other major metabolites (if applicable) in plasma

    Measured: Pre-dose up to 120 hours after dosing,or until termination criteria met

  4. Elimination Half-Life (t1/2)

    Pharmacokinetic parameters for zorifertinib, its metabolite (AZ'1168), and other major metabolites (if applicable) in plasma

    Measured: Pre-dose up to 120 hours after dosing,or until termination criteria met

  5. Terminal Rate Constant (λz)

    Pharmacokinetic parameters for zorifertinib, its metabolite (AZ'1168), and other major metabolites (if applicable) in plasma

    Measured: Pre-dose up to 120 hours after dosing,or until termination criteria met

  6. Apparent Volume of Distribution (Vz/F)

    Pharmacokinetic parameters for zorifertinib, its metabolite (AZ'1168), and other major metabolites (if applicable) in plasma

    Measured: Pre-dose up to 120 hours after dosing,or until termination criteria met

  7. Apparent Clearance (CLz/F)

    Pharmacokinetic parameters for zorifertinib, its metabolite (AZ'1168), and other major metabolites (if applicable) in plasma

    Measured: Pre-dose up to 120 hours after dosing,or until termination criteria met

  8. Mean Residence Time (MRT)

    Pharmacokinetic parameters for zorifertinib, its metabolite (AZ'1168), and other major metabolites (if applicable) in plasma

    Measured: Pre-dose up to 120 hours after dosing,or until termination criteria met

  9. Incidence and severity of Adverse Events (AEs)

    All adverse events were classified according to the CTCAE (version: 6.0)

    Measured: Pre-dose up to 312 hours after dosing, or until termination criteria met

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jun 2026
  2. Study start6 Jul 2026
  3. Primary completion18 Jul 2026
  4. Study completion3 Aug 2026

Resources

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
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07620951
Sponsor's protocol ID
AZD3759-CIT-101
Status last verified
Sep 2026
First submitted
20 May 2026
Last updated
22 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing [14C]Zorifertinib Oral Formulation in people with EGFR Mutant Advanced Non-small Cell Lung Cancer and Central Nervous System (CNS) Metastases, run by Alpha Biopharma (Jiangsu) Co., 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 6 inclusion and 29 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 22 Sep 2026. 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?

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?

Total radioactive recovery and cumulative total radioactive recovery in urine and feces at each time interval (time frame: Pre-dose up to 312 hours after dosing, or until termination criteria met). The study lists 11 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 NCT07620951.

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 22 Sep 2026.

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